Legend Biotech is seeking participants for Legend's Manufacturing Management, Leadership Development Program as part of the Technical Operations team based in Raritan, NJ.

Role Overview

The Early Career Leadership Program at Legend Biotech is a strategic, enterprise-focused development experience designed to accelerate the growth of high-potential professionals early in their careers. Rooted in our commitment to cultivating enterprise-minded, value-driven leaders, this program provides structured rotational exposure, executive mentorship, and real-time business impact across scientific, operational, and corporate functions.

Legend’s U.S. manufacturing network supports clinical trials and commercial CAR-T therapies for patients across the United States, with CARVYKTI® available at more than 140 treatment centers nationwide. Through our collaboration with Johnson & Johnson, we continue to expand manufacturing capabilities across both regions to meet growing patient demand. top

Join us in redefining what’s possible and build a career where your growth and patient impact go hand in hand

Key Responsibilities

• The Manufacturing Hi-Po Leadership Development Program at Legend Biotech is a 2.5–3 year leadership accelerator designed for high-potential Master’s graduates seeking to build careers at the intersection of advanced therapy manufacturing, operational strategy, and global supply.
• Participants will complete multiple-functional rotations (12 months each) within areas of Global Manufacturing; including Manufacturing Science & Technology (MSAT), Quality, Manufacturing, or Supply Chain over the course of the program. Rotations are tailored based on individual development goals, business needs, and participant interests, allowing candidates to gain targeted experience across key operational functions.
• This structured program integrates high-impact operations experiences, executive mentorship, and a Leadership Development Series focused on developing leaders at every level — from leading self and others to influencing senior stakeholders and driving enterprise-wide business outcomes.
• At Legend Biotech, we believe our people are our greatest asset. This program reflects our unwavering commitment to professional development, career mobility, and long-term leadership growth; empowering early-career talent to take on meaningful challenges, expand their impact, and shape the future of our organization.

Requirements

• Recent M.S or M.A Graduate (Class of 2023-2026)
• 2-3 years of professional experience in life sciences, manufacturing, engineering, or supply chain environments
• Strong analytical, problem-solving, and cross-functional collaboration skills.
• Demonstrated leadership potential and aspiration to grow into future operational and enterprise leadership roles.
• Degree in Biomedical Engineering, Supply Chain/Manufacturing, or related discipline.

#Li-CC1

#Li-Onsite

Legend Biotech is seeking a Principal Scientist, Lentivirus Downstream Process Development as part of the Technical Development team based in Somerset, NJ.

Role Overview

The Principal Scientist, Lentivirus Downstream Process Development, will be a key technical leader responsible for designing, optimizing, and scaling purification processes for lentiviral vectors (LVV) within our innovative pipeline. This role focuses on delivering high-quality vector products to support LVV generation and other advanced cell therapy programs. The successful candidate will drive scientific excellence in downstream processing (DSP)—including clarification, chromatography, TFF, sterile filtration and fill/finish—ensuring processes are robust, scalable, and phase-appropriate for GMP manufacturing. This position demands a blend of hands-on technical mastery and strategic thinking to accelerate timelines while maintaining a patient-focused approach.

Key Responsibilities

• Design and execute highly efficient purification strategies for lentiviral vectors, specifically optimized for CAR-T applications.
• Direct the development and optimization of downstream processes including and not limited to: clarification (depth filtration, centrifugation), chromatography (AEX, SEC, HIC), and Tangential Flow Filtration (TFF) for concentration and diafiltration.
• Provide hands-on training as needed.
• Direct the translation of bench-scale processes to GMP manufacturing, ensuring seamless technology transfer and providing troubleshooting support during clinical production runs
• Lead the execution of study protocols to define operating parameters and performance limits; implement state-of-the-art knowledge management for DSP data.
• Communicate the potential for issues and delays along with solutions and mitigation approaches.
• In collaboration with the Senior Leaders, CMC Project Manager, Project Leader, and other technical leads identify project acceleration opportunities.
• Leverage advanced science and technology to maximize vector recovery, purity, and potency, identifying creative solutions to define unknowns in the viral vector field.
• Guide a team of scientists in the execution of project-specific activities, fostering a culture of transparency, scientific rigor, and continuous improvement.
• Author and serve as a primary reviewer for technical documents, including development reports, SOPs, and CMC sections for regulatory submissions (IND/IMPD).
• Work closely with Upstream Process Development and Analytical Development teams to ensure integrated and holistic process outcomes.
• Tech transfer process to/from other Legend sites or CDMOs
• Resolve conflict and proactively identify/address performance issues.
• Ensure compliance with regulatory requirements. 

Requirements

• Advanced degree (PhD preferred, or MS) in Chemical Engineering, Biomedical Engineering, Virology, Molecular Biology, or a related field.
• 8+ years (PhD) or 10+ years (MS) of experience in process development or manufacturing within a biotech or pharmaceutical setting.
• Deep technical hands-on experience in purification, chromatography, and TFF specifically for viral vectors (Lentivirus preferred)
• Strong understanding of GMP manufacturing requirements and CMC strategies for early-phase clinical trials.
• Deep knowledge and hands-on experiences in cell and lentiviral vector technologies within the current emerging field
• Ability to implement closed-system processes and maximize cost effectiveness
• Strong knowledge in engineering modeling and optimization.
• Excellent leadership, emotional intelligence, and communication skills; ability to maintain composure and strategic focus during challenging development timelines.
• Creative, strategic thinking
• Strong troubleshooting skills
• Preferred experience in developing vector processes tailored for CAR-T generation and systemic delivery
• Preferred experience in handling large scale(>50L) purification process.
• Language: English. Mandarin is a plus. 

#Li-JR1

#Li-Hybrid

Job Summary of the Material Control Technician

The Material Control Technician will help support and execute process controls for human tissue, critical supplies, and support functions throughout the Axogen Processing Center cGMP facility for surgical transplantation while ensuring compliance with applicable federal, state and AATB/FDA regulations. The Material Control Technician will support the Supervisor, Lead Technician and Engineering team as required in the Manufacturing and Processing Operations.

Requirements of the Material Control Technician

• High School Diploma or equivalent
• Valid driver’s license
• Experience in a cGMP environment is preferred, not required
• Forklift Cetification is preferred, not required
• ERP system experience is preferred, not required
• Must be proficient and able to effectively assist in training of current processes.
• Experience in 1 or more additional cross-functional support skills required (e.g. environmental monitoring, inventory recording, etc.).
• Ability to make decisions based on awareness of area operations is necessary.
• Good written/verbal communication skills, interpersonal skills and analytical troubleshooting skills.
• Must be able to deal with people under high pressure and in a constantly changing environment.
• Must be able to travel to and work at other Axogen locations on an as needed basis.
• Requires exerting up to 50 pounds of force occasionally and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to lift, carry, push, pull or otherwise move objects.
• Requires the following physical abilities: mental acuity, visual acuity, walking and standing for longer period of time, repetitive motion, speaking, grasping, manual dexterity, talking, and hearing.

Responsibilities of the Material Control Technician

The specific duties of the Material Control Technician include but are not limited to:

• Receives, stores, picks and ships raw materials, supplies and/or finished products in conjunction with internal and external requirements.
• Handles, moves and stores various non-hazardous and hazardous materials.
• Coordinates timely accurate flow of materials from warehouse inventory to work-in-process/production areas.
• Coordinates timely accurate flow of finished products to support shipments to customers and other destinations.
• Responsible for implementing and maintaining the effectiveness of the quality system, including maintaining proper first in and first out.
• Store, issue, or prepare materials in the warehouse, verifying the lot number, quantity, release status and any other unique identifiers using good documentation practices.
• Check materials against packaging lists, invoices, freight bills or other pertinent documentation to assure conformity and accuracy.
• Deliver materials to processing areas in a timely manner, maintain proper FIFO flow of raw materials and other time sensitive supplies.
• Maintain and sustain organized workspaces for tissue, supplies, and finished goods warehouse areas.
• Maintain accurate records and reconcile inventory errors.
• Accountable for personal safety and adhering to the safety guidelines.
• Must supply materials to functional areas or move to and from dock areas to maintain efficient shipping and receiving operations.
• This position is accountable for complying with applicable FDA (GMP), USDA, OSHA and Axogen regulations, policies, procedures or guidelines, assembly and review, processing, debridement, cleaning, safety, cleanroom behavior and documentation as needed.
• Participate in daily stand-up meetings, continuous improvement projects, adhere to established work practices like Kanban signals, and 5S initiatives.
• Performs other duties as directed by Supervisor.
• May be required to work in other Axogen roles or departments as needed.
• Complies with all company policies, procedures and SOPs.
• Required to cover call schedule, to include, holidays and weekends as assigned.

Working & Environmental Conditions

• Subject to handle potential infectious human tissue, nerves, umbilical cords, blood and bodily fluids. Also, subject to handle chemicals and hazardous / non-hazardous waste. Work involves risks or discomforts which require proper standard and universal precautions in a Biomedical manufacturing environment e.g., use of safe workplace practices with manufacturing equipment, wearing PPE during various tasks/activities including but not limited to, gowns, gloves, masks and safety glasses. Potential exposure to latex from gloves.
• May be required to sit for 2-4 hours or more debriding and evaluating unprocessed and processed human tissue. Required to wear surgical magnification loupes for 2-4 hours or more to evaluate tissue unprocessed and processed tissue.

Location

913 Industrial Drive Place, Vandalia, OH  45377

Benefits/Compensation

Applied Research Engineer II, Human Wellness 

Needham, MA, United States 

Our purpose is to positively impact people’s lives every day in every home around the world! We work very hard to provide our consumers with high-quality, exciting 5-star products that make life easier. We thrive on passion and innovation and are looking for great people, with great ideas, who want to build the next big thing and develop while they do. 

Are you ready to take your skills to the next level and join a company that thrives on Innovation?  If yes, I have the perfect position for you!  

Our mission to positively impact people's lives every day in every home around the world allows our employees to be thinkers and tinkerers, designers and doers, creators and number crunchers, makers of things they love.  As we continue to grow, we are excited to add an Applied Research Engineer II to our global team.  

Overview 

The Research and Development Team at SharkNinja is seeking an experienced, versatile Engineer II to help deliver an exceptional pipeline of new technologies across the beauty and human wellness spaces. In this role, you will work at the intersection of research and engineering—translating scientific insight into real-world solutions that meaningfully improve people’s lives. 

As an Engineer II, you will take ownership of complex, open-ended technical challenges, partner closely with cross-functional teams, and influence technical direction and product definition through technology exploration and applied scientific research. This role is well-suited for someone who thrives in ambiguity, takes initiative, and enjoys shaping problems as much as solving them. 

What You’ll Do 

• Evaluate emerging technologies and help guide research roadmaps and investment decisions 
• Lead applied research initiatives in human health and wellness to test hypotheses and support product claims 
• Develop and refine algorithms, models, and experimental methods across a broad range of biomechanical and physiological data streams 
• Synthesize findings and communicate clearly through presentations and written materials for both technical and non-technical audiences 
• Collaborate closely with engineering, product, marketing, and regulatory partners to translate research into impact 
• Engage with external experts to accelerate innovation and support clinical studies for medical devices 
• Mentor junior researchers and provide hands-on technical leadership across projects 
• Uphold high standards for scientific rigor, reproducibility, and ethical research practices 

Attributes and Skills 

• MS in Bioengineering, Biomedical Engineering, Mechanical Engineering, Physical Therapy, or a related field—or equivalent practical experience  with 2+ years' of experience or a PhD in the same fields with 0+ years' of experience.
• 0 - 2+ years of applied research experience in industry, research labs, or translational academic environments 
• Strong foundation in experimental design, statistical analysis, and data interpretation 
• Hands-on experience working in laboratory settings with diverse test equipment and instrumentation 
• Knowledge in one or more of the following areas: human anatomy and physiology, biomechanics, physics of biological tissues, or human gait and movement 
• Proficiency in computational programming (e.g., Python, MATLAB) 
• Ability to work independently, prioritize effectively, and make progress amid evolving requirements 
• This is an in-person role based in our Needham, MA office 

Preferred Attributes 

• Demonstrated success translating research into shipped products, deployed systems, or validated claims 
• Experience developing wearable sensors or medical devices 
• Hands-on prototyping and experimental protocol development experience 
• Comfort balancing multiple initiatives and adapting to shifting priorities while maintaining focus on long-term goals 

Work Period: July 2026 to December 2026

Location & Schedule: This is a full-time, 40-hour-per-week position with 5 days per week onsite in Needham, MA.  There is no relocation or housing assistance for this position.

Join the SharkNinja Early Edge Experience: Built for early career talent. Geared toward impact. Driven by speed. Whether you're in a co-op or internship, our early talent program is designed to provide valuable exposure to the industry and a fast-paced professional environment. You’ll dive into meaningful projects and tasks that sharpen your skills and deepen your knowledge. Along the way, you’ll benefit from professional development opportunities, community events, and connections that make your experience well-rounded and enriching. Your time with us will culminate in an opportunity to showcase your contributions and learnings to SharkNinja leaders because this is a program for those ready to shape what’s next — fast.

This role: As a Mechanical Engineering Co-op, Wearable and Biomedical Devices at SharkNinja, you will work alongside a world-class group of engineers working on wearable, biosensing, and medical device technologies within our Shark skincare space. This role offers hands-on experience across the full product lifecycle, including prototyping, testing, data analysis, and refinement of devices that integrate sensors, embedded hardware, and user-centered design. You will contribute to the development of systems that measure and interpret physiological signals such as ECG, PPG, EMG, temperature, motion, and impedance, applying core concepts in biomechanics, signal processing, and control systems. This role provides hands-on exposure across the full product lifecycle, from early concept development and prototyping through testing, refinement, and validation. You will support the design and evaluation of sensor-enabled systems, contribute to data-driven engineering decisions, and collaborate across disciplines to deliver solutions that balance performance, usability, and reliability. If you are motivated by applying engineering fundamentals to real-world health and wellness challenges and want to help shape the future of how people interact with technology on and around the body, this could be your next role.

Here are some of the EXCITING things you’ll get to do:

• Support research, ideation, and exploration of wearable and biomedical product opportunities within the Shark skincare space (like Shark CryoGlow)
• Apply knowledge of biomechanics, signal processing, or control systems to real-world engineering challenges
• Support the collection, interpretation, and analysis of physiological and system-level data to inform design and performance decisions
• Work with sensor-enabled systems and data acquisition platforms to help evaluate functionality and user experience
• Use MATLAB and or Python to analyze data, visualize trends, and support the development of analytical tools and models
• Participate in design discussions and technical reviews, considering principles of safety, usability, and reliability throughout development
• Gain exposure to materials and components intended for skin-contact and body-worn applications, with an emphasis on user comfort and performance
• Collaborate cross-functionally with engineers, designers, and product partners to align technical insights with user needs
• Develop an understanding of the user journey and the role of data-driven design in creating intuitive, trustworthy health-focused products

 ATTRIBUTES & SKILLS:

• Education: Current student in a related bachelor's, master’s, or doctorate program, or has graduated from such a program within the past year
• Coursework or project experience in biomechanics, signal processing, or control systems
• Must be able to work a full-time, 40-hour-per-week schedule with 5 days per week onsite in Needham, MA
• Familiarity with physiological signals (e.g., ECG, PPG, EMG, temperature, motion, impedance) and basic signal processing concepts
• Working knowledge of MATLAB and/or Python for data analysis, visualization, and algorithm development
• Strong understanding of mechanical engineering/physics fundamentals including thermodynamics, fluid mechanics, and mechanical design
• Understanding of medical device design principles, including safety, usability, and reliability
• Solid analytical skills, attention to detail, and relentless drive to identify potential problems and take responsibility for their resolution
• Intellectual curiosity and creativity, strong first principles thinking, positive can-do attitude, and proven ability to deliver robust, elegant, and innovative solutions to complex design challenges
• Willingness to roll up sleeves and dive into hands-on development and testing workstreams
• Ability to communicate with both technical and non-technical colleagues  , effectively, and concisely
• Comfortable multitasking and responding quickly to shifting priorities without losing sight of longer-term projects
• Passionate about product design & function
• Can identify, solve, implement and verify technical solutions autonomously and as part of a team
• “Hands-on” experimental testing of some sort, either in the workshop or in a science context
• Experience with Developer kits such as Python, Arduino, Raspberry Pi is desirable
• Experience with biocompatible materials, electrodes, or skin-contact sensors is preferred
• Embodies SharkNinja's success drivers:
  • Rarely Satisfied – Adopt a “no delays” mentality in delivering against market needs/timing
  • Progress over Perfection - Make quick, daily progress and continuously adapts to achieve results rather than requiring perfect planning
  • Details Make the Difference - Can coordinate timelines & deliverables to ensure accuracy and consistency across all consumer-facing materials
  • Winning is a Team Sport - Ability to develop strong cross-functional relationships
  • Communicate for Impact - Strong communication skills - ability to deliver effective presentations to all levels of management

Please note that, due to the high volume of applications for early talent roles, response times may vary depending on the specific role and timeline. Our team appreciates your patience!

Job Summary of the Sr. IT Project Manager, ERP & Process Improvement

We are seeking a highly skilled Sr. IT Project Manager with proven success delivering IT projects ranging from simple enhancements to complex, multi-system initiatives and implementations within the biomedical, life sciences, or healthcare technology sectors.  This hybrid role is based out of Tampa, FL, supporting the IT organization with a blend of project management, business process improvement, and organizational change management. This role will partner with cross-functional operational and corporate teams to improve systems, strengthen processes, deliver projects on time and on budget, and ensure successful adoption of technology solutions in a regulated environment.

Requirements of the Sr. IT Project Manager, ERP & Process Improvement

Required

• • Minimum 5 years of progressive project management experience in IT environments.
  • Minimum 3 end-to-end ERP Implementations.
  • Grasp of broader enterprise systems such as ERP, LIMS, HRIS, QMS, MES, CRM, data platforms, and/or validated systems.
  • Proven business process improvement achievements with quantifiable results.
  • Hands-on experience executing change management strategies and adoption plans.
  • Strong communication and executive presentation skills.

 Preferred

• • Certifications: PMP, Lean Six Sigma Green/Black Belt, and/or Agile.
  • Experience in biomedical, life sciences, pharma, biotech, med device, or healthcare.
  • Familiarity with regulatory frameworks and validated IT environments.
  • Previous work within an IT PMO or Digital Transformation group.

Responsibilities of the Sr. IT Project Manager, ERP & Process Improvement

The specific duties of the Sr. IT Project Manager, ERP & Process Improvement include but are not limited to:

Project Management

• • Lead full-lifecycle projects for IT systems supporting lab operations, research, clinical workflows, QA/RA, and enterprise functions.
  • Build and manage detailed project plans, schedules, budgets, and governance structures.
  • Ensure compliance with GxP, FDA guidance, HIPAA, cybersecurity standards, CSV, and organizational policies.
  • Manage vendors, contracts, and cross-functional resources supporting system implementations and enhancements.
  • Identify and mitigate risks, issues, and interdependencies with data-driven decision-making.

Business Process Improvement (BPI)

• • Analyze current-state processes across biomedical and IT domains; design measurable future-state improvements.
  • Facilitate process mapping, Lean/Six Sigma problem solving, and workflow optimization sessions.
  • Implement process controls and documentation aligned with regulatory and audit expectations.
  • Partner with QA/RA, lab, and business owners to ensure processes remain efficient and compliant.

Organizational Change Management (OCM)

• • Develop and execute OCM strategies for IT-led transformations, system deployments, and process redesigns.
  • Conduct stakeholder analysis, change impact assessments, and readiness evaluations.
  • Create communications, training, and adoption plans tailored to technical and scientific audiences.
  • Track adoption KPIs and adjust strategies to ensure sustained behavior and process change.

Stakeholder & Cross-Functional Collaboration

• • Serve as a strategic liaison across IT, research, lab operations, clinical, regulatory, supply chain, and leadership teams.
  • Facilitate workshops, requirements sessions, demos, and executive updates.
  • Drive alignment and ensure stakeholders understand impacts, timelines, and decisions.
  • Collaborate with cross-functional teams and vendors to deliver projects on time and within budget
  • Ensure system scalability, security, and adherence to best practices for enterprise architecture

Location

111 W. Oak Ave., Tampa, FL 

Benefits/Compensation

The Opportunity:

We are seeking an experienced drug developer and effective leader to serve as Executive Director of Clinical Development in support of Revolution Medicines’ clinical-stage molecule(s) and/or pre-clinical molecule(s). In this critical role, you will be responsible for developing the strategic plans and ensuring efficient operational execution of the molecule(s)’ clinical development program in one or more disease indications, from early-stage studies to regulatory submissions and potential commercialization. You will play a pivotal role in shaping the future of our pipeline and driving the development of transformative therapies for patients.

• Provide critical insights/contributions and implement comprehensive/execute upon the clinical development plans for Revolution Medicines’ molecules, ensuring alignment with scientific, regulatory, and commercial objectives.

• Lead, mentor, and manage a high-performing cross-functional team of clinical development professionals, fostering a culture of collaboration, innovation, and excellence.

• Oversee all aspects of clinical trial design and execution, including site selection, patient recruitment, data management, and regulatory compliance.

• Establish and maintain strong relationships with clinical investigators, regulatory agencies, and key stakeholders.

• Gather, analyze and interpret clinical data, providing strategic insights to inform critical decisions and guide program development.

• Manage clinical development timelines effectively, ensuring efficient resource allocation and achievement of milestones.

• Stay abreast of the latest scientific advancements and regulatory trends in the field of clinical development.

• Partner with cross-functional teams, including research, regulatory affairs, commercial, and finance, to ensure seamless program execution and achieve shared goals.

• Manage multiple direct reports; potentially be a manager of managers.

Required Skills, Experience and Education:

• MD, PhD or similar advanced biomedical graduate degree with 13+ or more years experience in pharmaceutical/biotech industry or academic background at the level of Associate Professor or higher.

• Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance as related to the pharmaceutical/biotech industry.

• Proven track record of successfully designing and conducting multiple clinical trials as part of a wider clinical development programs from early-stage to late-stage, direct experience with Phase 1 drug development.

• Experience authoring and clinical development strategy(ies) and bringing forward for governance.

• Extensive understanding of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA, and other relevant guidelines and regulations.

• Proven experience to steer an IMP during its clinical development plan through major and varied Health Authority interactions (e.g. FDA, EMA, others). Has led Health Authority interaction(s).

• Strong orientation to teamwork. Excellent leadership, communication, and interpersonal skills, with the ability to inspire, motivate and mentor a diverse team.

• Expertise in building and maintaining strong relationships with internal and external stakeholders.

• Superb strategic thinking and analytical skills, with the ability to make data-driven decisions in a fast-paced environment. Able to recognize trade-off decisions and can determine priorities and goals.

• Outstanding written and business presentation skills. Experience publishing results of a clinical trial in a peer-reviewed journal is required.

• Proven ability to manage budgets and timelines effectively.

• Passion for innovation and a commitment to developing therapies that make a meaningful difference in patients' lives.

Preferred skills:

• Experience in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources in the pharmaceutical/biotech industry.

• Experience creating clinical development strategy(ies) that led to label-enabling outcomes and commercialization.

• Experience submitting an NDA/BLA/MAA to global health authorities is a significant plus.

• Has led regulatory and other internal partners/stakeholders in the completion and submission of regulatory documentation. Successfully provided clinical science information and input for regulatory development of label(s) and packaging language, etc.

• Has led or overseen data generation to address unmet medical needs and identify new or extended Clinical Development studies for the assigned program or other programs.

• Direct experience with Phase IV drug development.

• Has proven abilities to present [a] compelling business case and facilitates effective and expeditious decision-making. Has demonstrated the ability to serve as a company spokesperson both internally and externally.

• Has demonstrated collaborate behaviors on enterprise-level strategic initiatives with a variety of internal and external partners and stakeholders - including clinical investigators/clinicians, scientists and key opinion leaders (KOLs), as well as internal groups, including other groups in development, research, business development, commercial, legal, etc. - resulting in demonstrable outcomes (e.g. new study proposals or new disease indications).

• Has demonstrated courage and conviction in past positions and responsibilities. Skilled in conflict resolution.  

  #LI-Hybrid  #LI-GL1

AI in Residence

AI in Residence is a highly selective role at the intersection of frontier machine learning and drug discovery. Designed as an industry alternative to a traditional postdoctoral position, the program is for exceptional researchers and engineers who want to apply advanced AI to real biomedical problems end to end, from data to deployed systems.

Residents join a small cohort working on high-impact AI efforts across Xaira. You’ll collaborate closely with AI scientists, research engineers, and drug discovery teams to design, build, and ship machine learning capabilities that directly influence therapeutic programs. This is hands-on, system-level work with real scientific consequence.

We’re looking for candidates with technical depth, intellectual independence, strong research judgment, and evidence of delivering high-quality work—whether through publications, open-source, or production systems.

What You’ll Do

• Develop and advance ML models for biological, preclinical, and translational datasets (e.g., multimodal omics, imaging, text, assay data)
• Design and implement scalable pipelines for data curation, training, evaluation, and inference integrated into discovery workflows
• Own projects end-to-end: problem framing → prototyping → validation → deployment
• Evaluate robustness and reliability (generalization, uncertainty, failure modes), plus interpretability where it supports scientific decision-making
• Contribute technical leadership by proposing new directions, shaping platform capabilities, and raising engineering/research standards through collaboration
  
  

You Might Work On

Examples include (not limited to):

• Foundation / representation models over multimodal biological and translational data
• Methods for small, biased, noisy datasets; distribution shift; and uncertainty estimation
• ML systems for experimental prioritization, assay interpretation, or translational signal discovery
• Evaluation frameworks and benchmarks tailored to discovery decision-making
• Tooling that makes models usable by scientists (interfaces, automation, monitoring)
  
  

What Success Looks Like

• You ship one or more models or pipelines that are used in real discovery workflows
• Your work improves decision quality (e.g., better prioritization, faster iteration, clearer uncertainty)
• You raise the bar on evaluation rigor and reproducibility (strong baselines, error analysis, reliable metrics)
• You leave behind maintainable systems (tests, documentation, monitoring) that others can build on
  
  

We Value

• Strong research judgment: choosing the right problems and knowing what “good evidence” looks like
• Rigor: careful experimental design, ablations, error analysis, and honest reporting
• Systems thinking: reliability, scalability, and maintainability—not just prototypes
  Clear communication: writing, documentation, and sharing decisions/assumptions
• Collaborative execution with scientific and engineering partners
  
  

Program Structure

Duration
6–12 months, with the possibility of extension or conversion to full-time

Start Dates
First hires beginning March 2026, with rolling applications and additional intakes in Summer and Fall 2026

Cohort Size
Small, highly selective cohort to enable meaningful ownership and close collaboration

Mentorship & Support
Dedicated technical mentor, plus structured feedback from senior AI, engineering, and scientific leadership

Publications & Presentations
We value scientific contribution and may support publications and conference presentations when appropriate. Publication scope and timing depend on project needs and are subject to internal review (e.g., IP and confidentiality). Authorship follows standard contribution-based guidelines.

Who Should Apply

We encourage applications from candidates who meet most of the following:

• Recent MS or PhD graduates (or equivalent research experience) in ML/AI, computational biology, biomedical engineering, or related fields
• Evidence of research excellence through high-quality publications or artifacts. Top venues (e.g., NeurIPS, ICML, ICLR, CVPR, ACL; Nature Methods, Cell Systems) are a plus, but strong preprints, open-source contributions, or shipped systems with demonstrated impact are equally compelling
• Demonstrated ability to lead substantial technical work with originality—new modeling ideas, rigorous experiments, or production-grade systems adopted by others
• Motivation to translate rigorous research into reliable, deployable AI systems that support therapeutic discovery
  
  

Please include a brief cover letter describing your interest in this role, why you’re excited about this area, and what you hope to gain from the experience.

Compensation:

The expected monthly compensation range is $10,000–$15,000, depending on experience and qualifications. We are open to higher compensation for candidates with exceptional experience or impact.

About the Role
We are looking for an AI Scientist to join our team at the intersection of machine learning and single-cell biology. This role will focus on developing and applying foundation models to large-scale perturb-seq and single-cell datasets to uncover new biological mechanisms and therapeutic opportunities. You will help design scalable ML architectures that can extract insight from high-dimensional perturbation data and integrate across multi-omic modalities.

Key Responsibilities

• Design, train, and refine foundation models tailored to perturb-seq and other single-cell datasets.
  Build pipelines for preprocessing, normalization, and integration of large-scale single-cell and perturbation data.
• Apply ML/AI approaches to model cellular responses to perturbations and identify causal biological insights.
• Collaborate with experimental biologists to align computational methods with experimental design and discovery goals.
• Develop multimodal integration approaches across transcriptomic, epigenomic, and proteomic single-cell readouts.
• Publish methods and results in top scientific journals and present at conferences.
  
  

Qualifications

• PhD or equivalent in Computational Biology, Computer Science, Bioinformatics, or related discipline.
• Strong expertise in single-cell data analysis, particularly perturb-seq 
• Hands-on experience with foundation models or large-scale self-supervised learning (e.g., transformers, variational autoencoders).
• Strong coding skills in Python, ML frameworks (PyTorch/TensorFlow), and single-cell analysis tools (Scanpy, Seurat).
• Experience in developing scalable ML methods for large biological datasets.
  
  

Preferred

• Background in causal inference, generative models, or representation learning for biological systems.
• Familiarity with multi-omics integration and cross-modal foundation models.
• Track record of impactful publications in computational biology, machine learning, or related fields.

Compensation

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants. We offer a competitive package that includes base salary, bonus, and equity. The base pay range for this position is expected to be $150,000 - $240,000 annually; however, the base pay offered may vary depending on the market, job-related knowledge, skills and capabilities, and experience.

Xaira Therapeutics an equal-opportunity employer. We believe that our strength is in our differences. Our goal to build a diverse and inclusive team began on day one, and it will never end.

TO ALL RECRUITMENT AGENCIES: Xaira Therapeutics does not accept agency resumes. Please do not forward resumes to our jobs alias or employees. Xaira Therapeutics is not responsible for any fees related to unsolicited resumes.

Role Overview
The Senior Director, Supply Chain and Strategic Sourcing will lead and integrate Xaira’s supply chain, procurement, and contract governance functions, ensuring reliable access to the external partners, platforms, and services that support Research, Biomedical AI, Platform Engineering, and Corporate teams.

This role is responsible for establishing disciplined sourcing strategy, strengthening vendor management, building contract governance infrastructure, and ensuring operational continuity across critical suppliers and service providers. The individual will provide strategic oversight while elevating two existing functions, procurement and contracts, into a cohesive, scalable supply chain capability.

Operating at the intersection of research, technology infrastructure, and external partnerships, This role is responsible for bringing strategic focus to how Xaira engages its external partners, ensuring that sourcing, vendor, and contract decisions serve the company's mission, growth, and long-term goals

Key Responsibilities

Supply Chain Leadership

• Develop and lead overall supply chain strategy
• Ensure continuity, reliability, and risk mitigation across critical vendors and external partners
• Oversee vendor selection, onboarding, performance monitoring, and renewal planning
• Provide leadership with visibility into external dependencies and operational risk exposure
• Map and monitor critical vendor dependencies across research services, cloud infrastructure, data providers, and platform suppliers

Strategic Sourcing

• Guide category strategy development across cloud infrastructure, AI/ML platforms, research services, data providers, lab suppliers, and corporate systems
• Oversee competitive sourcing processes and major vendor negotiations
• Ensure cost discipline and long-term value across supplier relationships
• Partner with Finance to strengthen forecasting, budget alignment, and spend transparency

Contracts and Governance

• Oversee contract negotiation and execution standards across MSAs, SOWs, SaaS agreements, data licenses, and research vendor agreements.
• Ensure structured intake, review, and lifecycle management processes are followed
• Establish clear governance for renewals, amendments, and contractual obligations
• Strengthen coordination between Legal, Finance, and operational stakeholders
• Build contract architecture that gives Legal and leadership a strategic view of risk

Leadership

• Lead and develop procurement and contracts team members
• Establish performance expectations, KPIs, and operating cadence
• Build scalable systems and processes appropriate for company growth
• Elevate supply chain operations from reactive processing to a strategic operational partner

Core Capabilities

• Supply Chain Integration and Operational Continuity
  Ability to ensure reliable supply and vendor performance across research services, cloud infrastructure, laboratory suppliers, and external partners while identifying and mitigating operational risks before they impact the organization.
• Advanced Strategic Sourcing and Negotiation
  Demonstrated ability to structure and lead complex negotiations across cloud infrastructure, software platforms, research services, and vendor agreements while balancing cost, flexibility, speed, and long-term value.
• Contract Architecture and Governance Design
  Ability to design and implement structured contract frameworks, approval workflows, and lifecycle management processes that create visibility, enforce standards, and reduce legal and financial exposure.
• Financial Stewardship and Vendor Risk Management
  Strong analytical capability to model vendor spend, forecast commitments, evaluate total cost of ownership, and proactively surface financial and operational risk.
• Cross-Functional Partnership and Organizational Influence
  Ability to align Legal, Finance, Research, and Engineering stakeholders around sourcing strategy, vendor commitments, and contractual decisions while balancing operational needs and risk management.

Qualifications

• 10+ years of experience in supply chain, procurement, or strategic sourcing leadership
• Experience operating in biotech, life sciences, or technology-driven R&D environments
• Demonstrated experience managing vendor ecosystems spanning cloud infrastructure, SaaS platforms, research services, or technical R&D environments
• Prior responsibility for leading both sourcing and contract management functions
• Proven ability to build structure and operational discipline in growth-stage organizations
• Strong financial acumen, vendor risk management capability, and negotiation experience

Compensation

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants. We offer a competitive package that includes base salary, bonus, and equity. The base pay range for this position is expected to be $215,000 - $280,000 annually; however, the base pay offered may vary depending on the market, job-related knowledge, skills and capabilities, and experience.

Xaira Therapeutics an equal-opportunity employer. We believe that our strength is in our differences. Our goal to build a diverse and inclusive team began on day one, and it will never end.

TO ALL RECRUITMENT AGENCIES: Xaira Therapeutics does not accept agency resumes. Please do not forward resumes to our jobs alias or employees. Xaira Therapeutics is not responsible for any fees related to unsolicited resumes.

About the Role

The Senior Director, Project Management, will lead cross-functional execution of the company’s most complex scientific and platform initiatives, ensuring work across biology, computational science, protein design, and engineering teams progresses with clarity, alignment, and momentum.Working closely with scientific and technical leadership, this individual translates strategic priorities into well-structured projects with clear scope, milestones, ownership, and dependencies. The role requires strong project management discipline combined with a product lens, helping teams prioritize work based on impact, define clear outcomes, and focus effort on the highest-value initiatives.Operating at the center of scientific, technical, and organizational execution, this leader brings structure to complex work while enabling teams to move quickly in a discovery-driven environment.

Key Responsibilities
Project Leadership

• Lead planning and execution of complex, cross-functional projects spanning research, computational science, protein design, and engineering teams
• Translate strategic priorities into clearly structured projects with defined scope, timelines, ownership, and success criteria
• Apply a product lens to project leadership, ensuring initiatives are prioritized based on impact, feasibility, and organizational goals
• Partner with scientific and technical leaders to define clear outcomes and success criteria rather than activity-based workstreams
• Manage scope intentionally, balancing scientific exploration with disciplined execution
• Identify risks early and implement mitigation strategies to maintain project momentum

Strategic Execution Partnership

• Partner with scientific and technical leadership to translate organizational priorities into executable project plans
• Help shape the sequencing of major initiatives to ensure resources are focused on the highest-impact work
• Provide leadership with clear visibility into progress, dependencies, and emerging execution risks across projects
• Frame execution progress, tradeoffs, and emerging risks in ways that enable leadership to make timely and informed decisions

Cross-Functional Alignment

• Align stakeholders across biology, computational science, protein design, and engineering teams around shared priorities and sequencing of work
• Coordinate interdependent projects across research and platform teams, ensuring work is sequenced appropriately and dependencies are clearly understood
• Identify points where progress in one initiative enables or constrains work in another, helping teams adjust plans accordingly
• Resolve cross-team bottlenecks and maintain forward momentum across projects

Project Operating Model

• Establish consistent project planning, tracking, and reporting practices across teams
• Introduce planning frameworks and decision rhythms that improve transparency and coordination
• Evaluate, select, and harmonize project management tools and platforms across the organization, ensuring teams operate with a consistent and scalable PM infrastructure
• Strengthen the organization’s ability to execute complex scientific and technical initiatives predictably

AI-Enabled Project Management

• Champion the integration of AI tools and workflows into project management practices, identifying opportunities to improve planning, tracking, risk identification, and reporting through intelligent automation
• Stay current on emerging AI capabilities relevant to PM operations and serve as an internal advocate for thoughtful, effective adoption across teams
• Partner with computational and engineering teams to ensure AI-driven initiatives are managed with appropriate rigor while leveraging AI to enhance the PM function itself

Team Leadership

• Build and develop a high-performing project management team as the organization grows
• Establish expectations for rigor, clarity, and accountability in project execution
• Mentor project managers to operate as strategic partners to scientific and technical leaders
• Define team structure, hiring priorities, and development pathways that scale with organizational growth
• Foster a culture of continuous improvement within the PM team, regularly evaluating and refining how the team operates

Core Capabilities

• Complex Project Execution - Demonstrated ability to lead large, cross-functional projects involving multiple stakeholders, dependencies, and evolving scientific priorities.
• Product-Oriented Thinking - Ability to approach project leadership with a product mindset—prioritizing work based on impact, defining clear outcomes, managing scope intentionally, and ensuring initiatives deliver meaningful value.
• Cross-Functional Leadership - Proven ability to align scientific, technical, and operational teams around shared priorities and drive execution through influence.
• Structured Planning and Risk Management - Strong capability in dependency mapping, risk identification, mitigation planning, and maintaining forward progress in complex environments.
• Executive Communication and Decision Framing - Ability to synthesize complex scientific and technical work into clear updates, priorities, and tradeoffs that support effective leadership decision-making.

Qualifications

• Bachelor’s degree required; advanced degree preferred (MBA, MS, PhD, or equivalent)
• 10+ years of experience leading complex cross-functional projects in biotech, TechBio, or similarly interdisciplinary environments where computational and experimental research intersect.
• Strong understanding of AI/ML-enabled biological research, with experience partnering closely with computational biology, protein design, biomedical AI, or research engineering teams.
• Experience working closely with scientific and engineering teams in research or platform settings
• Deep understanding of drug development processes, including preclinical through early clinical stages, with the ability to connect research and platform initiatives to the broader development continuum
• Demonstrated ability to bring structure and clarity to complex initiatives in fast-moving organizations
• Strong organizational, communication, and stakeholder alignment skills
• Proven ability to influence highly skilled teams without relying on formal authority
• Experience managing and developing high-performing teams

Compensation

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants. We offer a competitive package that includes base salary, bonus, and equity.  The base pay range for this position is expected to be $225,000 - $285,000 annually; however, the base pay offered may vary depending on the market, job-related knowledge, skills and capabilities, and experience.

Xaira Therapeutics an equal-opportunity employer. We believe that our strength is in our differences. Our goal to build a diverse and inclusive team began on day one, and it will never end.

TO ALL RECRUITMENT AGENCIES: Xaira Therapeutics does not accept agency resumes. Please do not forward resumes to our jobs alias or employees. Xaira Therapeutics is not responsible for any fees related to unsolicited resumes.

About the Role
We are seeking a scientific leader to serve as our Director of Biomarkers and Experimental Medicine. This role will create and execute biomarker strategies across discovery and early development, grounded in human biology and designed to scale from target-agnostic disease understanding through program-specific development. You will work closely with Biomedical AI to use multi-modal human data to identify biomarker signals, define patient hypotheses, and establish biomarkers that guide indication choices, patient selection, and proof-of-biology.

A core part of the role is building biomarker capability before programs fully crystallize. This includes defining disease-state and patient stratification frameworks, developing assay and data standards, and creating a biomarker toolkit that can be applied as targets emerge.

Key Responsibilities

• Help create and execute strategies and incorporate human patient data to build AI models for patient stratification, target validation and biomarker discovery, in conjunction with a cross-functional team of experts including Biomedical AI
• Establish a target-agnostic biomarker strategy that defines disease biology, patient subgroups, and measurable signals of disease state, progression, and response potential, even before a specific therapeutic target is selected.
• Define biomarker hypotheses and evidence plans that connect human biology to program direction, including how biomarkers will influence indication strategy, cohort definitions, and clinical readiness.
• Work closely with Biomedical AI/ML to translate biomarker questions into ML-ready problem definitions, including cohort definitions, endpoints, labels, success criteria, and validation expectations.
• Identify and prioritize AI/ML model outputs needed for biomarker work, including patient segmentation, biomarker signal models, multi-modal integration, and response or outcome prediction where appropriate.
• Lead assay strategy and readiness planning, including platform choices, fit-for-purpose validation, sample strategy, and decision points that allow teams to act on biomarker results.
• Create standards for biomarker and model quality, reproducibility, and documentation so outputs are decision-grade and usable across programs.
• Build biomarker data assets and workflows that scale, including reference cohorts, baseline datasets, and repeatable analyses that can be reused as targets and indications evolve.
• Drive cross-functional alignment so biomarker insights consistently inform discovery priorities, program selection, and early development planning.
• Establish and manage an external network of biomarker experts, clinical and translational advisors, and key opinion leaders to pressure-test strategy and strengthen clinical relevance.

Qualifications

• PhD, MD, or MD/PhD with 8+ years of experience in biomarkers, translational science, or human biology within biotech or pharma.
• Deep expertise in biomarker discovery and development, including experience defining biomarker strategies that support program decisions and differentiation.
• Strong experience with human data and multi-modal biology, including genetics and omics, and comfort operating when targets and programs are still being defined.
• Demonstrated ability to work closely with AI/ML teams and translate biomarker questions into ML-ready problem definitions and model development plans.
• Track record of building biomarker capabilities and standards in early-stage environments, including assay readiness, evidence planning, and cross-functional execution.
• Excellent communication and scientific judgment, with the ability to drive clear decisions from complex data, and work collaborative in multidisciplinary teams.

Compensation

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants. We offer a competitive package that includes base salary, bonus, and equity.  The base pay range for this position is expected to be $196,000 - $245,000 annually; however, the base pay offered may vary depending on the market, job-related knowledge, skills and capabilities, and experience.

Xaira Therapeutics an equal-opportunity employer. We believe that our strength is in our differences. Our goal to build a diverse and inclusive team began on day one, and it will never end.

TO ALL RECRUITMENT AGENCIES: Xaira Therapeutics does not accept agency resumes. Please do not forward resumes to our jobs alias or employees. Xaira Therapeutics is not responsible for any fees related to unsolicited resumes.

About the Role
We are seeking a Biomedical AI Engineer to design and deploy agentic AI systems that can reason over biomedical knowledge, plan multi-step analyses, and autonomously integrate diverse scientific data sources to accelerate therapeutic discovery.

This role goes beyond traditional LLM + RAG pipelines. You will build AI agents that can retrieve, synthesize, evaluate, and act on biomedical information across literature, omics datasets, and clinical records operating as intelligent systems embedded within discovery workflows.

Key Responsibilities

• Design and implement agentic AI architectures capable of multi-step reasoning, planning, and tool use in biomedical contexts.
• Develop LLM-based agents that dynamically retrieve, rank, and synthesize knowledge from scientific literature, knowledge graphs, omics datasets, and clinical data.
• Build memory and feedback mechanisms that allow agents to refine hypotheses, update context, and adapt to evolving data.
• Integrate external tools (analysis pipelines, simulation engines, statistical models, databases) into autonomous agent workflows.
• Architect scalable systems that combine structured and unstructured biomedical data within production-grade AI environments.
• Collaborate closely with computational biologists, translational scientists, and software engineers to embed agentic systems into real-world discovery pipelines.
• Evaluate robustness, reliability, and interpretability of autonomous systems in high-stakes biomedical settings.

Qualifications

• Degree in Computer Science, Machine Learning, Computational Biology, Biomedical Informatics, or related field.
• Strong hands-on experience with large language models, including fine-tuning, alignment, and structured prompting.
• Experience building agent-based systems or complex LLM orchestration frameworks (e.g., multi-agent systems, tool-using LLMs, planning modules).
• Proficiency in Python and modern ML frameworks (PyTorch, JAX, TensorFlow).
• Experience working with large-scale biomedical datasets (genomics, transcriptomics, clinical records, or scientific corpora).

Preferred

• Experience designing autonomous research assistants or AI systems that perform multi-step scientific reasoning.
• Familiarity with knowledge graphs, hybrid symbolic-neural systems, or multimodal foundation models.
• Understanding of privacy, security, and regulatory considerations in healthcare AI.

Compensation

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants. We offer a competitive package that includes base salary, bonus, and equity. The base pay range for this position is expected to be $190,000 - $280,000 annually; however, the base pay offered may vary depending on the market, job-related knowledge, skills and capabilities, and experience.

Xaira Therapeutics an equal-opportunity employer. We believe that our strength is in our differences. Our goal to build a diverse and inclusive team began on day one, and it will never end.

TO ALL RECRUITMENT AGENCIES: Xaira Therapeutics does not accept agency resumes. Please do not forward resumes to our jobs alias or employees. Xaira Therapeutics is not responsible for any fees related to unsolicited resumes.

• Develop multimodal foundation models spanning image and molecular data
• Design approaches that unify representation learning and generative modeling
• Train large-scale models on structured, high-dimensional datasets
• Explore cross-modal alignment, prediction, and generation
• Build scalable systems for data processing, training, and evaluation
• Work in a research-driven environment with evolving problem definitions

• Experience with representation learning (self-supervised, contrastive, masked modeling, etc.)
• Experience with generative modeling (diffusion, autoregressive models, VAEs, or related approaches)
• Proficiency in Python, ML frameworks, and CI/CD (PyTorch, JAX, etc.)

• Work on multimodal learning or cross-domain representation learning
• Experience with image data, molecular / omics-like data, or both
• Familiarity with large-scale training

• Exposure to biological or scientific datasets
• Experience with paired or partially aligned multimodal data
• Comfortable working in open-ended, evolving problem spaces

Compensation

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants. We offer a competitive package that includes base salary, bonus, and equity. The base pay range for this position is expected to be $170,000 - $240,000 annually; however, the base pay offered may vary depending on the market, job-related knowledge, skills and capabilities, and experience.

Xaira Therapeutics an equal-opportunity employer. We believe that our strength is in our differences. Our goal to build a diverse and inclusive team began on day one, and it will never end.

TO ALL RECRUITMENT AGENCIES: Xaira Therapeutics does not accept agency resumes. Please do not forward resumes to our jobs alias or employees. Xaira Therapeutics is not responsible for any fees related to unsolicited resumes.

Job Summary of the Material Control Technician

The Material Control Technician will help support and execute process controls for human tissue, critical supplies, and support functions throughout the Axogen Processing Center cGMP facility for surgical transplantation while ensuring compliance with applicable federal, state and AATB/FDA regulations. The Material Control Technician will support the Supervisor, Lead Technician and Engineering team as required in the Manufacturing and Processing Operations.

Requirements of the Material Control Technician

• High School Diploma or equivalent
• Valid driver’s license
• Experience in a cGMP environment is preferred, not required
• Forklift Cetification is preferred, not required
• ERP system experience is preferred, not required
• Must be proficient and able to effectively assist in training of current processes.
• Experience in 1 or more additional cross-functional support skills required (e.g. environmental monitoring, inventory recording, etc.).
• Ability to make decisions based on awareness of area operations is necessary.
• Good written/verbal communication skills, interpersonal skills and analytical troubleshooting skills.
• Must be able to deal with people under high pressure and in a constantly changing environment.
• Must be able to travel to and work at other Axogen locations on an as needed basis.
• Requires exerting up to 50 pounds of force occasionally and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to lift, carry, push, pull or otherwise move objects.
• Requires the following physical abilities: mental acuity, visual acuity, walking and standing for longer period of time, repetitive motion, speaking, grasping, manual dexterity, talking, and hearing.

Responsibilities of the Material Control Technician

The specific duties of the Material Control Technician include but are not limited to:

• Receives, stores, picks and ships raw materials, supplies and/or finished products in conjunction with internal and external requirements.
• Handles, moves and stores various non-hazardous and hazardous materials.
• Coordinates timely accurate flow of materials from warehouse inventory to work-in-process/production areas.
• Coordinates timely accurate flow of finished products to support shipments to customers and other destinations.
• Responsible for implementing and maintaining the effectiveness of the quality system, including maintaining proper first in and first out.
• Store, issue, or prepare materials in the warehouse, verifying the lot number, quantity, release status and any other unique identifiers using good documentation practices.
• Check materials against packaging lists, invoices, freight bills or other pertinent documentation to assure conformity and accuracy.
• Deliver materials to processing areas in a timely manner, maintain proper FIFO flow of raw materials and other time sensitive supplies.
• Maintain and sustain organized workspaces for tissue, supplies, and finished goods warehouse areas.
• Maintain accurate records and reconcile inventory errors.
• Accountable for personal safety and adhering to the safety guidelines.
• Must supply materials to functional areas or move to and from dock areas to maintain efficient shipping and receiving operations.
• This position is accountable for complying with applicable FDA (GMP), USDA, OSHA and Axogen regulations, policies, procedures or guidelines, assembly and review, processing, debridement, cleaning, safety, cleanroom behavior and documentation as needed.
• Participate in daily stand-up meetings, continuous improvement projects, adhere to established work practices like Kanban signals, and 5S initiatives.
• Performs other duties as directed by Supervisor.
• May be required to work in other Axogen roles or departments as needed.
• Complies with all company policies, procedures and SOPs.
• Required to cover call schedule, to include, holidays and weekends as assigned.

Working & Environmental Conditions

• Subject to handle potential infectious human tissue, nerves, umbilical cords, blood and bodily fluids. Also, subject to handle chemicals and hazardous / non-hazardous waste. Work involves risks or discomforts which require proper standard and universal precautions in a Biomedical manufacturing environment e.g., use of safe workplace practices with manufacturing equipment, wearing PPE during various tasks/activities including but not limited to, gowns, gloves, masks and safety glasses. Potential exposure to latex from gloves.
• May be required to sit for 2-4 hours or more debriding and evaluating unprocessed and processed human tissue. Required to wear surgical magnification loupes for 2-4 hours or more to evaluate tissue unprocessed and processed tissue.

Location

913 Industrial Drive Place, Vandalia, OH  45377

Benefits/Compensation

Team Description:

The Neuralink Clinical team is at the heart of an ecosystem that merges neuroscience, engineering, and medicine. We work to shape the future of brain-computer interface (BCI) technology through the planning, launch, and execution of groundbreaking human clinical trials. Our team is built on a foundation of excellence, aiming to uphold the highest standards of Good Clinical Practice (GCP) while redefining what’s possible and revolutionizing the way people interact with technology. Through strict compliance with ethical and regulatory protocols, we focus on ensuring the well-being of our trial participants while advancing the frontiers of neuroscience! Every day will bring fresh challenges and unprecedented opportunities to pioneer new approaches in the pursuit of our mission. From navigating regulatory pathways, designing trial protocols and documentation, and executing clinical trials, our team is instrumental in translating Neuralink’s BCI technology for use in people!

Job Description and Responsibilities:

As a Clinical Scientist I, you will support the development, design, and execution of Neuralink’s clinical evidence strategy. This role focuses on translating product and research objectives into clinical study designs, supporting data analysis, and ensuring scientific rigor across clinical programs.

This individual is  a self-driven and analytically strong individual who can contribute to clinical strategy while executing with precision. The ideal contributor is detail-oriented, collaborative, and comfortable working in a fast-paced, multidisciplinary environment.

In this role, you will:

• Support the design and development of clinical study protocols, including endpoints, inclusion/exclusion criteria, and statistical considerations
• Contribute to clinical strategy by translating research and product goals into evidence-generating study plans
• Partner with other team members to support execution of clinical studies and ensure alignment between scientific intent and operational delivery
• Build and maintain strong working relationships with internal teams, investigators, and external partners
• Support preparation of study-related documents, including protocols, investigator brochures, clinical study reports, and regulatory submissions
• Contribute to EDC and CRF design by ensuring alignment between protocol objectives, endpoints, and data collection strategy
• Translate clinical and scientific requirements into structured, high-quality data capture and validation approaches
• Assist in data review, analysis, and interpretation to evaluate safety and performance outcomes
• Contribute to development of abstracts, presentations, and publications
• Support interactions with ethics committees (e.g., IRB, RECs) and regulatory bodies as needed
• Ensure scientific and clinical activities are conducted in compliance with Good Clinical Practice (GCP), applicable regulations, and internal SOPs
• Identify data trends, inconsistencies, or risks and proactively communicate findings to the broader team

Required Qualifications:

• Familiarity with statistical methods or programming (e.g., Python, R)
• 5+ years of experience in clinical research or scientific roles within medical devices or related fields
• Strong analytical and problem-solving skills with the ability to interpret complex data
• Familiarity with clinical study design, endpoints, and data analysis concepts
• Working knowledge of Good Clinical Practice (GCP) and basic regulatory requirements (e.g., ISO 14155)
• Ability to work cross-functionally with clinicians, engineers, and operational teams
• Strong written and verbal communication skills, particularly in scientific and technical contexts
• High attention to detail and ability to manage multiple priorities

Preferred Qualifications:

• Experience with neurological, neurosurgical, or implantable medical device studies
• Experience supporting protocol development, data analysis, or clinical reporting
• Publications or scientific presentations in biomedical engineering or neuroscience
• PhD  in neuroscience, biomedical engineering, or a related field
  

Additional Requirements and Competencies: 

• Willingness to travel (up to ~20–30%) to support site visits, investigator meetings, and study activities
• Strong organizational and documentation skills
• Ability to work independently while collaborating closely with cross-functional teams
• Adaptability and comfort in a fast-paced, high-growth environment
• Commitment to scientific rigor, patient safety, and high-quality evidence generation

Team Description:

Join our innovative Equipment Quality Team, a dynamic collective of experts dedicated to maintaining the precision and efficacy of high-tech equipment in preclinical and manufacturing domains. Engage with the latest in biomedical devices, industrial instrumentation, and high-end technologies like lasers and RF systems. As pioneers who've crafted a robust equipment program from scratch, we champion creative problem-solving and strive to set industry benchmarks. Immerse yourself in a mission-critical role that propels safety and regulatory compliance to new heights, and become part of a collaborative force driving the future of biomedical quality.

Job Description and Responsibilities:

Neuralink is seeking an Equipment Quality Technician with a strong knowledge of applied metrology. This technician will calibrate, repair, and perform preventative maintenance on equipment in the quality program. In addition, they will troubleshoot and repair instruments and systems. This role requires participation in cross-functional teams and some travel. Additionally, you will be expected to:

• Calibrate and perform preventive maintenance on any instrument or device in the equipment quality program with little to no supervision
• Provide the technical expertise for assisting management in developing work procedures and protocols
• Assist in the design, fabrication, check-out, start-up, and acceptance of new or modified equipment
• Determine and requisition parts required for maintenance repairs
• Adhere to cGxP guidelines, SOPs, and safety rules/regulations
• Assist management with determining work schedules and project costs
• Work closely with cross-functional team members  in regards to continuous improvement activities, solving problems, and improving overall product quality
• Explain calibration issues and processes to equipment custodians and management

Required Qualifications:

• Ability to comprehend and apply manuals and schematics for maintenance and troubleshooting
• Proficiency in using hand tools, physical/dimensional test instruments, and electronic test instruments
• Able to work in a dynamic, fast-paced environment
• Strong interpersonal skills: ability to work with colleagues and cross-functional teams in a professional and organized manner
• Competence in operating computing hardware and standard software
• Minimum of 1 year of experience related industrial instrumentation/calibration experience and/or training; or equivalent combination of education and experience
• Willingness to assist with other Quality Engineering activities such as facilities, equipment, and facilities validation

Preferred Qualifications:

• Experience in PMEL, TMDE, Metrology, Calibration, Instrumentation, Validation, or Biomedical Equipment
• Associates or Bachelors Degree in Science, Technology, Engineering, Mathematics or military training in calibration
• Relevant experience working in a highly regulated (e.g., GMP, GCP, GLP) environments

Team Description:

The Preclinical Team is responsible for designing, conducting, documenting, analyzing, and reporting preclinical studies. Our team provides a means for ensuring the safe, effective, and robust implantation of Neuralink devices into animals and, ultimately, humans.

Job Description and Responsibilities:

The Study Coordinator provides critical operational and project management support to the Study Director in GLP-regulated preclinical studies for Neuralink devices. This role handles the majority of day-to-day coordination, scheduling, data compilation, and administrative tasks, enabling the Study Director to focus on scientific oversight, data interpretation, and regulatory compliance. The Study Coordinator acts as a key liaison across the preclinical team, technical staff, and cross-functional groups to ensure studies progress smoothly, on time, and in compliance with protocols and SOPs. The Study Coordinator will:

• Support the Study Director in developing study protocols, amendments, and related documentation.
• Facilitate cross-functional communication, establish and track study timelines, and prepare/lead study milestone meetings.
• Identify and help eliminate roadblocks that could delay study progress.
• Assist with implementation of test methods and practices described in the study protocol and SOPs.
• Help ensure all experimental data, including observations of unanticipated responses of the test system, are accurately recorded and verified.
• Manage the study schedule, alerting the Study Director and team to critical data collection points or deadlines.
• Support the documentation and addressing of self-reported or QAU-generated deviations that may affect study quality.
• Compile data, organize contributing scientist reports, and assist in preparing the final study report so it accurately reflects study results.
• Maintain organized study files, track communications, and support archiving of data, documentation, protocols, specimens, and reports per GLP.
• Coordinate day-to-day study activities with technical staff, veterinary teams, and external partners (e.g., CROs if applicable).
• Contribute to internal tracking systems, meeting minutes, and status updates for the Preclinical Team.

Required Qualifications:

• Bachelor’s degree  in biology, neuroscience, biomedical engineering, animal science, or a related field.
• Minimum 1 year of experience in preclinical research support, study coordination, or project management (academic experience applies).
• Solid understanding of GLP regulations (21 CFR Part 58), basic knowledge of ISO 10993, and familiarity with in vivo animal studies.
• Strong organizational and project management skills with proven ability to manage timelines and multiple priorities.
• Excellent attention to detail and proficiency in data compilation, documentation, and Microsoft Office (or equivalent) tools.
• Experience working in or supporting animal research facilities with IACUC protocols.

Preferred Qualifications:

• Master’s degree  in biology, neuroscience, biomedical engineering, animal science, or a related field.
• Direct experience with neural device implantation studies or neurosurgical models.
• Background in a CRO or medical device preclinical setting.
• Familiarity with electronic data capture systems or GLP-compliant documentation platforms.

Additional Requirements and Competencies:

• Willingness to work in an animal research facility environment (with required training and PPE).
• Flexibility in schedule to support critical study timepoints.

Team Description:

The Neuralink Clinical team is at the heart of an ecosystem that merges neuroscience, engineering, and medicine. We work to shape the future of brain-computer interface (BCI) technology through the planning, launch, and execution of groundbreaking human clinical trials. Our team is built on a foundation of excellence, aiming to uphold the highest standards of Good Clinical Practice (GCP) while redefining what’s possible and revolutionizing the way people interact with technology. Through strict compliance with ethical and regulatory protocols, we focus on ensuring the well-being of our trial participants while advancing the frontiers of neuroscience! Every day will bring fresh challenges and unprecedented opportunities to pioneer new approaches in the pursuit of our mission. From navigating regulatory pathways, designing trial protocols and documentation, and executing clinical trials, our team is instrumental in translating Neuralink’s BCI technology for use in people!

Job Description and Responsibilities:

As a Field Clinical  Engineer, you will be on the front lines of Neuralink’s clinical programs, working directly with participants, clinicians, and internal teams to translate cutting-edge neurotechnology into meaningful functional outcomes. This role is ideal for individuals with a background in PM&R, occupational therapy, or physical therapy who also have experience in medical devices and thrive in dynamic clinical environments.

You will play a critical role in bridging clinical care, engineering, and research by supporting device use, optimizing participant performance, and ensuring high-quality data collection in both clinical and home settings.

This role requires someone who is hands-on, clinically grounded, technically curious, and able to adapt quickly. You should be comfortable working with participants with significant neurological impairments and motivated by improving independence and quality of life.

In this role, you will:

• Work directly with study participants to support device use, training, and optimization during clinical sessions and at home
• Apply principles of rehabilitation (PM&R, OT, PT) to maximize participant outcomes and functional performance with the system
• Collaborate closely with surgeons, investigators, and site staff to ensure seamless clinical execution across all phases of the study
• Serve as the primary interface between participants and the technology, troubleshooting issues in real time and escalating when needed
• Support surgical and post-operative workflows, including intraoperative and early post-implant sessions where applicable
• Ensure high-quality, protocol-compliant data collection by aligning participant activities with study endpoints and data capture requirements
• Partner with clinical, engineering, and data teams to translate real-world use into actionable insights for product and algorithm development
• Identify trends in participant performance, usability challenges, and safety signals, and communicate clearly to cross-functional teams
• Contribute to development and refinement of training protocols, user workflows, and clinical best practices
• Support site onboarding, training, and ongoing engagement to ensure consistency and scalability across clinical sites
• Assist in preparation for regulatory inspections and ensure activities are conducted in compliance with GCP, protocol requirements, and internal procedures
• Travel to clinical sites as needed to support study execution and participant care

The ideal candidate:

• Has a clinical background in PM&R, occupational therapy, or physical therapy, with hands-on experience working with neurological populations (e.g., SCI, ALS, stroke)
• Has experience working with medical devices in a clinical or field-based role
• Is highly adaptable, proactive, and comfortable operating in a fast-paced, evolving environment
• Is technically curious and able to engage with engineers to troubleshoot and improve system performance
• Communicates clearly and builds trust with participants, clinicians, and cross-functional teams
• Is detail-oriented and understands the importance of protocol adherence and data integrity in clinical research

Required Qualifications: 

• Clinical training and hands-on experience in PM&R, occupational therapy, or physical therapy, with a focus on neurological populations (e.g., SCI, ALS, stroke)
• 3+ years of experience in a clinical, field-based, or medical device–adjacent role (rehab, neuromodulation, assistive technology, or similar)
• Demonstrated experience working directly with patients and clinicians in dynamic care environments
• Strong problem-solving skills with the ability to troubleshoot clinical and technical issues in real time
• Ability to interpret participant performance, functional outcomes, and device behavior to inform next steps
• Comfort working with technology, including basic data review and interaction with software-driven systems (no need to be a coder, but not afraid of one either)
• Working knowledge of clinical research principles, including protocol adherence, endpoint-driven activities, and data quality expectations
• Familiarity with Good Clinical Practice (GCP) and general clinical study conduct
• Ability to collaborate effectively across clinical, engineering, and operations teams
• Strong communication skills, with the ability to engage both participants and highly technical teams
• High attention to detail, with the ability to manage multiple participants, sites, and priorities simultaneously
• Willingness to travel frequently to support clinical sites and participants

Preferred Qualifications:

• Degree or formal training in bioengineering, biomedical engineering, or a related field, with exposure to neurotechnology or implantable systems
• Experience working with neuromodulation, brain-computer interfaces, or other neurorehabilitation technologies
• Prior experience in a clinical field engineer, clinical specialist, or applications role within a medical device company
• Experience supporting surgical procedures, intraoperative environments, or early post-implant programming and troubleshooting
• Familiarity with signal-based systems (e.g., neural data, EMG, EEG) and comfort interpreting system performance in real time
• Exposure to rehabilitation technology integration, including assistive devices, digital interfaces, or adaptive control systems
• Experience supporting multi-site clinical studies or working directly with investigators and study coordinators
• Comfort working with data systems (e.g., EDC platforms, basic data visualization tools) to review participant performance and study metrics
• Understanding of usability, human factors, and patient-centered design principles
• Prior involvement in training clinicians or participants on device use and workflows
• Experience working in early-stage or rapidly evolving clinical programs where processes are still being defined

Team Description:

The Next Gen team at Neuralink is developing the next generation of brain-computer interfaces. We are laying the groundwork for intuitive, high-dimensional, and bidirectional interfaces between brains and machines, with the goal of helping people challenged by a variety of neurological disorders and conditions. Our team consists of scientists and engineers, working closely together to define the engineering requirements for these future products. As a Neuroengineer on this team, you will contribute across a wide range of projects, from designing novel experimental preparations, to interpreting neural signals and behavioral data, to developing novel BCI paradigms. Successful candidates will be highly adaptable, able to deploy their core technical and creative skills to tackle a wide range of problems, and have a keen sense of urgency.

Job Description and Responsibilities:

• Develop computational models of, and design encoding strategies for, electrical stimulation
• Design, execute, interpret, and communicate the results of neural recording and stimulation experiments
• Implement end-to-end hardware and software solutions for prosthetic vision, including machine vision algorithms, smart glasses, and eye tracking technology
• Run and support research sessions in coordination with software engineers, field engineers, and animal specialists
• Present results in a collaborative setting

Required Qualifications: 

• Evidence of exceptional ability in neuroscience, biomedical engineering, electrical engineering, machine learning, or a related field
• 4+ years of academic or industry experience
• A strong understanding of the scientific method and engineering first principles
• Fluency with Python for data analysis

Preferred Qualifications: 

• Experience with modern statistical inference and machine learning, including for machine vision applications
• Experience with neural stimulation
• Experience modeling the influence of electrical stimulation on neural activity, for example using the NEURON modeling environment
• Experience modeling electric fields using finite element modeling (FEM)
• Experience building and programming experimental instrumentation 
• Experience with in-vivo electrophysiology, awake behaving recordings, and in particular, closed-loop brain-computer interface

Team Description:

The Next Gen team at Neuralink is developing the next generation of brain-computer interfaces. We are laying the groundwork for intuitive, high-dimensional, and bidirectional interfaces between brains and machines, with the goal of helping people challenged by a variety of neurological disorders and conditions. Our team consists of scientists and engineers, working closely together to define the engineering requirements for these future products. As a Mechanical engineering Intern on this team you will contribute across a wide range of projects, from designing novel benchtop experiment setups to test the next generation of implants. Successful candidates will be highly adaptable, able to deploy their core technical and creative skills to tackle a wide range of problems, and have a keen sense of urgency.

Job Description and Responsibilities:

As a Mechanical Engineering Intern, you will design and build versatile benchtop test setups for evaluating next-generation brain-computer interface (BCI) implants. These setups will enable rapid algorithm iteration and system level validation. You will collaborate closely with the Next-Gen team to define requirements and implement best practices for scalable, reusable test hardware. Specifically, you will:

• Design and build custom benchtop fixtures and electrical/mechanical assemblies to test implant prototypes and related hardware
• Develop setups that mimic neural environments, including spiking-activity emulators, saline or tissue-like baths, and controlled noise sources to replicate in-vivo signal conditions
• Establish and document SOPs for assembly, calibration, and routine testing to ensure repeatability and reliability
• Integrate electrical and mechanical components to support algorithm development, automated data collection, and noise characterization
• Collaborate across disciplines to translate experimental needs into robust solutions
• Iterate and generalize test platforms for future implant designs and evolving experimental requirements

Required Qualifications:

• Currently pursuing a Bachelor’s, Master’s, or PhD degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or a related field 6+ months of relevant academic coursework or project experience
• 9+ months of experience applying technical skills outside the classroom (e.g., personal projects, prior internships, or work experience)
• 1+ years of mechanical design experience
• Strong understanding of engineering first principles
• Effective written and verbal communication skills

Preferred Qualifications: 

• 1+ years of mechanical engineering industry experience, including owning products from concept to production
• Familiarity with machining and rapid prototyping technologies
• Experience with electrical engineering, data acquisition modules

Team Description:

As part of the Surgery & Robot Hardware, the Robot Manufacturing Team is responsible for producing and scaling the precisely engineered robotic systems and custom hardware that enable our life-changing surgical procedures. Balancing immediate production needs with long-term scalability, we drive manufacturing innovation to ensure the safety, reliability, and high-quality execution of every surgical implant.

Job Description and Responsibilities:

The Robot Manufacturing Intern will contribute directly to the production and scaling of Neuralink's advanced surgical robotic systems. This role provides hands-on experience in a fast-paced, high-precision manufacturing environment, focusing on developing processes, improving efficiency, and ensuring the quality and reliability of critical hardware used in our surgical procedures

• Manufacturing Process Support: Assist the team in the assembly, testing, and documentation of robotic components and systems.
• Process Improvement: Identify and implement improvements to existing manufacturing workflows to increase throughput, reduce errors, and enhance product quality.
• Documentation and Control: Help create and maintain detailed manufacturing work instructions, process flow diagrams, and standard operating procedures (SOPs) to ensure compliance with quality systems.
• Tooling and Fixture Design: Work on the design and fabrication of jigs, fixtures, and production aids to streamline assembly and inspection tasks.
• Quality Assurance: Perform in-process quality checks and contribute to failure analysis and root cause investigations for non-conforming materials or devices.
• Data Analysis: Collect, analyze, and report on manufacturing data to track key performance indicators (KPIs) and support data-driven decisions.

Required Qualifications:

• Currently pursuing a Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or a closely-related engineering field.
• Demonstrated passion and aptitude for hands-on technical work, manufacturing, or robotics, evidenced by relevant coursework, technical clubs, or personal projects.
• Strong foundational understanding of physics and mathematics relevant to engineering principles.
• Proven ability to be highly detail-oriented and organized in a high-precision environment.
• Excellent written and verbal communication skills for creating clear documentation and collaborating with a technical team.
• Must be able to commit to a full-time intern schedule.

Preferred Qualifications:

• Prior hands-on experience in a manufacturing or lab environment related to robotics or high-precision assembly
• Proficiency with SolidWorks or similar CAD software for designing production aids and tooling
• Familiarity with regulated environments (e.g., medical device, ISO 13485) and Quality Management Systems (QMS) documentation

Pay Transparency:

Based on California law, the following details are for California individuals only:

California Hourly Range: 

$25.00/hr USD

Team Description:

As part of the Surgery & Robot Hardware Department, the Surgical Consumables Team is responsible for producing a wide range of critical mechanical devices that enable our life-changing surgical procedures. Balancing immediate needs with long-term scalability, we drive innovation with precisely engineered tools that ensure safety, reliability, and high-quality surgical execution.

Job Description and Responsibilities:

We’re looking for a Manufacturing Engineer to help scale the manufacturing of consumables used in our robotic surgeries. These consumables include the Needle Cartridge (the end effector that inserts electrodes into the cortex) as well as other complex mechanical assemblies and surgical proxies, like the one being assembled here.

In this role, you will help expand our team’s capabilities by supporting the build-out of a new manufacturing site in Texas while sustaining production at existing sites. You’ll work hands-on to troubleshoot manufacturing issues, analyze data, improve processes, and design fixtures. You will collaborate closely with hardware designers, machinists, quality engineers, and the surgery team to ensure parts are built correctly, released on time, and delivered where they’re needed. 

You will contribute to technical solutions for complex manufacturing problems and help design processes that scale as production ramps. This role is well suited to someone who enjoys working closely with hardware, learning how products move from development to production, and operating in a fast-paced environment. The Manufacturing Engineer will:

• Support day-to-day production to meet consumables demand across the company
• Provide manufacturability input as products move into more mature lifecycle stages
• Design, test, and implement production fixtures, tooling, workstations, and assembly aids
• Troubleshoot manufacturing issues, perform root cause analysis, and implement corrective actions
• Support quality control activities in compliance with Design Control requirements, cGMP, FDA regulations, and internal policies
• Generate and maintain manufacturing documentation, including work instructions, Device Master Records (DMRs), and Design History Files (DHFs)
• Conduct risk assessments and support mitigation efforts to ensure product safety and reliability
• Drive continuous improvement efforts focused on yield, throughput, and process robustness

Required Qualifications:

• Strong interest in manufacturing small, safety-critical assemblies where precision and quality are paramount
• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, Biomedical Engineering, or a related field, or equivalent experience
• 1+ year of experience in manufacturing engineering or engineering design
• Experience in Solidworks (preferred), OnShape, Creo, or an equivalent CAD program
• Demonstrated ability to execute on hardware-focused projects
• Hands-on experience physically building hardware (machining, fabrication, soldering, assembly, prototyping, etc.); personal projects are a plus
• A genuine interest in manufacturing and passion for learning

Preferred Qualifications:

• Experience working in a manufacturing environment
• Familiarity with ISO 13485, FDA 21 CFR Part 820, or other regulated manufacturing standards
  
  

Additional Requirements and Competencies:

• This role will initially require frequent travel to Fremont, CA, which is expected to decrease over time

Team Description:

The Neuralink Clinical team is at the heart of an ecosystem that merges neuroscience, engineering, and medicine. We work to shape the future of brain-computer interface (BCI) technology through the planning, launch, and execution of groundbreaking human clinical trials. Our team is built on a foundation of excellence, aiming to uphold the highest standards of Good Clinical Practice (GCP) while redefining what’s possible and revolutionizing the way people interact with technology. Through strict compliance with ethical and regulatory protocols, we focus on ensuring the well-being of our trial participants while advancing the frontiers of neuroscience! Every day will bring fresh challenges and unprecedented opportunities to pioneer new approaches in the pursuit of our mission. From navigating regulatory pathways, designing trial protocols and documentation, and executing clinical trials, our team is critical  in translating Neuralink’s BCI technology for clinical use!

Job Description and Responsibilities:

As a Clinical Program Manager, you will be the primary architect of Neuralink’s human clinical trial operations, transforming high-level strategy into rigorous, executable clinical programs. We are seeking a high-autonomy leader who thrives on ambiguity and drives projects to completion with surgical precision. In our hyper-dynamic environment, you aren't just managing timelines—you are building the infrastructure for the future of neurotechnology. You will be expected to:

Strategic Oversight & Relationship Management

• Act as the Principal Lead for complex clinical programs, owning end-to-end delivery and ensuring all milestones align with broader organizational objectives.
• Cultivate High-Stakes Partnerships across internal engineering and regulatory teams, as well as external vendors, strategic partners, and world-class clinical research sites.
• Champion Stakeholder Readiness by overseeing the training and credentialing of cross-functional teams, ensuring every contributor is equipped to operate within the trial’s rigorous requirements.

Operational Excellence & Scalability

• Engineer Scalable Frameworks to expand clinical operations across diverse global geographies, prioritizing safety, quality, and regulatory compliance at every inflection point.
• Lead Commercial & Financial Negotiations with trial sites, driving contract execution, budget optimization, and long-term financial planning to maximize trial efficiency without compromising site engagement.
• Drive Data Intelligence by leading the synthesis and analysis of clinical data to provide actionable insights for program refinement.

Compliance & Regulatory Stewardship

• Navigate Global Regulatory Landscapes to secure study approvals and maintain impeccable standing with Institutional Review Boards (IRB), Research Ethics Committees (REC), and relevant governing bodies.
• Enforce Rigorous Quality Standards, maintaining an expert-level command of Good Clinical Practices (GCP), international regulatory requirements, and site-specific Standard Operating Procedures (SOPs).
• Foster a Culture of Accountability, proactively identifying operational risks and implementing mitigation strategies to ensure the integrity of the clinical program.

Required Qualifications: 

Strategic Leadership & Clinical Expertise

• Extensive Industry Tenure: 7+ years of progressive leadership experience in clinical research, specifically within Class III medical devices, neurology, or high-complexity life sciences.
• Clinical Architecture: Advanced proficiency in clinical study design, endpoint selection, and the development of robust data analysis plans for first-in-human or pivotal trials.
• Regulatory Mastery: Deep technical knowledge of Global Good Clinical Practice (GCP) and international regulatory standards (e.g., ISO 14155, MDR, FDA 21 CFR Part 812).

Data Intelligence & Analytical Rigor

• Quantitative Fluency: Professional experience leveraging statistical methods or programming languages (Python, R) to drive data-led decision-making and trial optimization.
• Complex Problem Solving: Proven track record of interpreting multi-dimensional datasets and translating complex scientific findings into executive-level strategy.
• Meticulous Precision: A high-level of organizational rigor with the ability to manage competing high-priority workstreams in a fast-paced, high-stakes environment.

Communication & Interdisciplinary Integration

• Cross-Functional Catalyst: Demonstrated success leading integration between neural engineering, clinical neurosurgery, and regulatory affairs to achieve unified program goals.
• Scientific Diplomacy: Exceptional written and verbal communication skills, with the ability to distill complex technical and clinical concepts for diverse audiences, from internal engineers to external ethics committees.
• Operational Autonomy: A self-starting leader who initiates critical workstreams independently and maintains a relentless focus on deadline accuracy and operational efficiency.

Mission-Critical Mindset

• High-Stakes Resilience: A documented history of thriving in high-pressure, rapidly evolving environments where pivots are frequent and the margin for error is razor-thin.
• Advocacy & Influence: Strong presence and "scientific diplomacy" skills, with the ability to represent Neuralink’s clinical vision to world-class neurosurgeons, key opinion leaders (KOLs), and global health authorities

Preferred Qualifications: 

Advanced Academic & Technical Background

• Advanced Degree: PhD, MD, or Master’s degree in a relevant field (e.g., Neuroscience, Biomedical Engineering, Clinical Research, or Biological Sciences).
• Neurotech Specialization: Direct experience managing clinical trials for Class III active implantable medical devices (AIMDs), specifically Brain-Computer Interfaces (BCI) or Neuromodulation systems.
• Computational Fluency: Advanced proficiency in Python or R for automated data visualization, clinical dashboarding, or sophisticated statistical modeling.

Strategic Clinical Leadership

• First-in-Human (FIH) Mastery: Proven success in leading Early Feasibility Studies (EFS) and navigating the unique safety and ethical rigors of pioneering human trials.
• Global Expansion Experience: Experience scaling clinical operations across international jurisdictions, including familiarity with O-US regulatory bodies and localized clinical trial infrastructure.
• Financial Stewardship: Demonstrated expertise in multi-million dollar budget management, including sophisticated resource allocation and vendor contract optimization.

Innovation & Process Design

• Clinical Systems Architecture: Experience implementing and optimizing Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and eTMF platforms for high-growth environments.
• Agile Clinical Operations: Ability to apply "lean" or "agile" methodologies to clinical trial workflows, reducing cycle times while maintaining absolute compliance.
• Interdisciplinary Synthesis: A rare ability to translate high-level engineering specifications into clinical protocols that are both scientifically rigorous and operationally feasible for surgical teams.

Job Summary of the Material Control Technician

The Material Control Technician will help support and execute process controls for human tissue, critical supplies, and support functions throughout the Axogen Processing Center cGMP facility for surgical transplantation while ensuring compliance with applicable federal, state and AATB/FDA regulations. The Material Control Technician will support the Supervisor, Lead Technician and Engineering team as required in the Manufacturing and Processing Operations.

Requirements of the Material Control Technician

• High School Diploma or equivalent
• Valid driver’s license
• Experience in a cGMP environment is preferred, not required
• Forklift Cetification is preferred, not required
• ERP system experience is preferred, not required
• Must be proficient and able to effectively assist in training of current processes.
• Experience in 1 or more additional cross-functional support skills required (e.g. environmental monitoring, inventory recording, etc.).
• Ability to make decisions based on awareness of area operations is necessary.
• Good written/verbal communication skills, interpersonal skills and analytical troubleshooting skills.
• Must be able to deal with people under high pressure and in a constantly changing environment.
• Must be able to travel to and work at other Axogen locations on an as needed basis.
• Requires exerting up to 50 pounds of force occasionally and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to lift, carry, push, pull or otherwise move objects.
• Requires the following physical abilities: mental acuity, visual acuity, walking and standing for longer period of time, repetitive motion, speaking, grasping, manual dexterity, talking, and hearing.

Responsibilities of the Material Control Technician

The specific duties of the Material Control Technician include but are not limited to:

• Receives, stores, picks and ships raw materials, supplies and/or finished products in conjunction with internal and external requirements.
• Handles, moves and stores various non-hazardous and hazardous materials.
• Coordinates timely accurate flow of materials from warehouse inventory to work-in-process/production areas.
• Coordinates timely accurate flow of finished products to support shipments to customers and other destinations.
• Responsible for implementing and maintaining the effectiveness of the quality system, including maintaining proper first in and first out.
• Store, issue, or prepare materials in the warehouse, verifying the lot number, quantity, release status and any other unique identifiers using good documentation practices.
• Check materials against packaging lists, invoices, freight bills or other pertinent documentation to assure conformity and accuracy.
• Deliver materials to processing areas in a timely manner, maintain proper FIFO flow of raw materials and other time sensitive supplies.
• Maintain and sustain organized workspaces for tissue, supplies, and finished goods warehouse areas.
• Maintain accurate records and reconcile inventory errors.
• Accountable for personal safety and adhering to the safety guidelines.
• Must supply materials to functional areas or move to and from dock areas to maintain efficient shipping and receiving operations.
• This position is accountable for complying with applicable FDA (GMP), USDA, OSHA and Axogen regulations, policies, procedures or guidelines, assembly and review, processing, debridement, cleaning, safety, cleanroom behavior and documentation as needed.
• Participate in daily stand-up meetings, continuous improvement projects, adhere to established work practices like Kanban signals, and 5S initiatives.
• Performs other duties as directed by Supervisor.
• May be required to work in other Axogen roles or departments as needed.
• Complies with all company policies, procedures and SOPs.
• Required to cover call schedule, to include, holidays and weekends as assigned.

Working & Environmental Conditions

• Subject to handle potential infectious human tissue, nerves, umbilical cords, blood and bodily fluids. Also, subject to handle chemicals and hazardous / non-hazardous waste. Work involves risks or discomforts which require proper standard and universal precautions in a Biomedical manufacturing environment e.g., use of safe workplace practices with manufacturing equipment, wearing PPE during various tasks/activities including but not limited to, gowns, gloves, masks and safety glasses. Potential exposure to latex from gloves.
• May be required to sit for 2-4 hours or more debriding and evaluating unprocessed and processed human tissue. Required to wear surgical magnification loupes for 2-4 hours or more to evaluate tissue unprocessed and processed tissue.

Location

913 Industrial Drive Place, Vandalia, OH  45377

Benefits/Compensation

Job Summary of the Material Control Technician

The Material Control Technician will help support and execute process controls for human tissue, critical supplies, and support functions throughout the Axogen Processing Center cGMP facility for surgical transplantation while ensuring compliance with applicable federal, state and AATB/FDA regulations. The Material Control Technician will support the Supervisor, Lead Technician and Engineering team as required in the Manufacturing and Processing Operations.

Requirements of the Material Control Technician

• High School Diploma or equivalent
• Valid driver’s license
• Experience in a cGMP environment is preferred, not required
• Forklift Cetification is preferred, not required
• ERP system experience is preferred, not required
• Must be proficient and able to effectively assist in training of current processes.
• Experience in 1 or more additional cross-functional support skills required (e.g. environmental monitoring, inventory recording, etc.).
• Ability to make decisions based on awareness of area operations is necessary.
• Good written/verbal communication skills, interpersonal skills and analytical troubleshooting skills.
• Must be able to deal with people under high pressure and in a constantly changing environment.
• Must be able to travel to and work at other Axogen locations on an as needed basis.
• Requires exerting up to 50 pounds of force occasionally and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to lift, carry, push, pull or otherwise move objects.
• Requires the following physical abilities: mental acuity, visual acuity, walking and standing for longer period of time, repetitive motion, speaking, grasping, manual dexterity, talking, and hearing.

Responsibilities of the Material Control Technician

The specific duties of the Material Control Technician include but are not limited to:

• Receives, stores, picks and ships raw materials, supplies and/or finished products in conjunction with internal and external requirements.
• Handles, moves and stores various non-hazardous and hazardous materials.
• Coordinates timely accurate flow of materials from warehouse inventory to work-in-process/production areas.
• Coordinates timely accurate flow of finished products to support shipments to customers and other destinations.
• Responsible for implementing and maintaining the effectiveness of the quality system, including maintaining proper first in and first out.
• Store, issue, or prepare materials in the warehouse, verifying the lot number, quantity, release status and any other unique identifiers using good documentation practices.
• Check materials against packaging lists, invoices, freight bills or other pertinent documentation to assure conformity and accuracy.
• Deliver materials to processing areas in a timely manner, maintain proper FIFO flow of raw materials and other time sensitive supplies.
• Maintain and sustain organized workspaces for tissue, supplies, and finished goods warehouse areas.
• Maintain accurate records and reconcile inventory errors.
• Accountable for personal safety and adhering to the safety guidelines.
• Must supply materials to functional areas or move to and from dock areas to maintain efficient shipping and receiving operations.
• This position is accountable for complying with applicable FDA (GMP), USDA, OSHA and Axogen regulations, policies, procedures or guidelines, assembly and review, processing, debridement, cleaning, safety, cleanroom behavior and documentation as needed.
• Participate in daily stand-up meetings, continuous improvement projects, adhere to established work practices like Kanban signals, and 5S initiatives.
• Performs other duties as directed by Supervisor.
• May be required to work in other Axogen roles or departments as needed.
• Complies with all company policies, procedures and SOPs.
• Required to cover call schedule, to include, holidays and weekends as assigned.

Working & Environmental Conditions

• Subject to handle potential infectious human tissue, nerves, umbilical cords, blood and bodily fluids. Also, subject to handle chemicals and hazardous / non-hazardous waste. Work involves risks or discomforts which require proper standard and universal precautions in a Biomedical manufacturing environment e.g., use of safe workplace practices with manufacturing equipment, wearing PPE during various tasks/activities including but not limited to, gowns, gloves, masks and safety glasses. Potential exposure to latex from gloves.
• May be required to sit for 2-4 hours or more debriding and evaluating unprocessed and processed human tissue. Required to wear surgical magnification loupes for 2-4 hours or more to evaluate tissue unprocessed and processed tissue.

Location

913 Industrial Drive Place, Vandalia, OH  45377

Benefits/Compensation

Job Summary of the Processing Technician

The Processing Technician will perform debridement and processing, packaging and labeling of human tissue products for surgical transplantation while ensuring compliance with applicable federal, state and AATB regulations. 

Requirements of the Processing Technician

• High School Diploma or equivalent.
• Universal precautions and sterile technique (i.e. surgical technician, medical assistant, lab technician) preferred. 

Responsibilities of the Processing Technician

• The specific duties of the Processing Technician include but are not limited to:
• Performs processing, debridement, packaging, labeling and shipment of finished product.
• Participates in the receiving and inspection of incoming unprocessed tissue.
• Utilizes special techniques, instrumentation, and equipment to clean and size tissue to specifications and protocols.
• Assists team lead with efforts in maintaining inventory levels on the core and dock for receiving supplies.
• Performs lab cleaning activities as required by policies, protocols, procedures, and SOPs.
• Work with Quality and Regulatory staff to ensure compliance with all federal, state, and AATB regulations and requirements, particularly those pertaining to manufacturing.
• Complete documentation as required in processing in accordance with standard operating procedures and quality standards.
• Assists with production records as needed.
• Complies with all company policies, procedures, and SOPs.
• Performs all other duties assigned by the supervisor. 

Physical Requirements

The work is medium work which requires exerting up to 60 pounds of force occasionally and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to lift, carry, push, pull or otherwise move objects. Additionally, the work requires the following physical abilities: mental acuity, visual acuity, walking, repetitive motion, speaking, grasping, manual dexterity, talking, and hearing.

Working & Environmental Conditions

Work involves risks or discomforts which require proper safety precautions in a Biomedical manufacturing environment e.g., use of safe workplace practices with manufacturing equipment, wearing gloves for PPE during various tasks/activities including but not limited to, gloves, masks and safety glasses avoidance of trips and falls, and observance of fire and building safety regulations. Occasional potential exposure to hazards such as chemicals, blood or bodily fluids, communicable diseases, saw blades, needles, or other sharp objects, moving mechanical parts, and latex exposure. 

Location

913 Industrial Drive Place, Vandalia, OH  45377

Benefits/Compensation

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

We are looking for a Process Engineer (level depends on experience) that is responsible for developing, implementing, and optimizing manufacturing packaging processes to improve efficiency, quality, and productivity. This engineer will work closely with cross-functional teams to identify areas for process improvement, troubleshoot issues, and ensure compliance with safety and regulatory standards in the pharmaceutical aseptic manufacturing or automated inspection & packaging areas. This position is 100% onsite at the Bloomington facility and reports directly to the Sr. Manager, Engineering & Maintenance.

The responsibilities:

• Demonstrates a strong ownership for the equipment and processes in the filling or packaging areas
• Implement process improvement projects that enhance efficiency, improve quality, and reduce costs for aseptic filling processes, lyophilization, or inspection & packaging processes
• Develop user requirements (URS), technical specification and design specifications for new processing (aseptic filling, lyophilization, equipment preparation, formulation) and/or automated inspection & packaging equipment and/or upgrades to existing equipment
• Author and execute protocols to include commissioning, qualification, and validation activities (FAT, SAT, IQ and OQ) for packaging systems
• Collaborates with external engineering firms or OEM in feasibility assessments, concept design, basic design, and detail design
• Develop and maintain project schedules using MS Project
• Collaborate with suppliers to source processing and/or packaging equipment parts to ensure quality standards are met
• Provide technical support and training to operations and maintenance on aseptic processing equipment or inspection & packaging equipment
• Interact with all functions and levels of management, ensuring effective, ongoing communication across teams and internal/external stakeholders
• Support with complex site investigation of key safety and production issues and events and work on the identification and implementation of CAPA (Corrective and Preventive Action) plans to address such events and prevent recurrence

Required qualifications:

• BS degree in Engineering (Chemical, Mechanical, Electrical, Packaging, Pharmaceutical, Biomedical), or a related technical field
• 1+ years of experience in aseptic processes or inspection & packaging engineering in the pharmaceutical industry (level hired for depends on years of experience)
• 0-2 years of experience (Level I)
• 2-5 years of experience (Level II)
• 5-8 years of experience (Level III/Sr.)
• 8+ years of experience (Level IV/Principal)
• Knowledge of the basic principles in aseptic processing and/or packaging engineering best practices
• Must be able to lead and execute engineering projects
• Strong understanding of packaging materials, processing, and testing methods
• Experience with PLC, HMI, Vision Systems and Building Management systems
• Strong oral and written communication skills
• Must be able to read mechanical, electrical, and P&ID drawings
• AutoCAD or equivalent component design knowledge
• Advanced proficiency in Microsoft Office Suite (Word, Excel, and Outlook)
• Experience and the ability to use enterprise software (examples include: JDE, Microsoft Dynamics, BPLM, Veeva, Trackwise, etc.)

 Physical / safety requirements:

• Duties may require overtime work, including nights and weekends
• Position requires sitting for long hours, but may also involve walking or standing for long periods of time
• Variable travel of 0-10% could be expected
• Must be able to lift, push, pull, and carry up to 50 lbs
• Must be able to lift 20 lbs overhead
• Must be able to wear personal protective equipment (PPE), as required

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

The Opportunity:

This role represents a unique opportunity to serve as a senior scientific and strategic leader within Cancer Immunology, with primary responsibility for driving the discovery and advancement of novel immuno-oncology targets and therapeutic modalities. We are seeking an accomplished leader who combines deep scientific expertise with strong people leadership to shape strategy, guide portfolio decisions, and advance high-impact discovery programs.

The successful candidate will lead a multidisciplinary team to progress innovative immuno-oncology programs from early discovery through Development Candidate nomination, while providing senior oversight of scientific integration across Discovery and Translational Cancer Immunology. This role reports to the Vice President and Head of Cancer Immunology and partners closely with Research and Development leadership to support portfolio prioritization and governance. Key aspects of the role include:

• Discovery Program Leadership & Protfolio Oversight: Provide executive-level leadership of Cancer Immunology discovery programs from project qualification through Development Candidate nomination. Drive the identification and validation of novel immuno-oncology targets, ensuring seamless progression of programs into Translational Cancer Immunology.

• Scientific Strategy & Platform Leadership: Define and evolve the scientific vision and long-term strategy for Cancer Immunology discovery. Provide senior oversight of the development and optimization of experimental platforms, including in vitro and in vivo models, phenotypic screening, and advanced assay toolkits. Champion the exploration and implementation of new therapeutic modalities, such as TCEs, ADCs, and bispecifics.

• Scientific Integration & Operational Excellence: Provide senior oversight of scientific integration across Discovery and Translational Cancer Immunology, ensuring operational rigor, platform support, and alignment of resources. Leverage enabling functions and data-driven insights to enhance experimental design, reproducibility, and program execution. Promote the development and deployment of modern data systems and analytics to advance scientific and operational excellence, enabling the establishment of a digitally empowered Cancer Immunology team within the broader organization.

• Cross-functional Collaboration: Act as a key partner to Research Leadership to support advancement of programs from early discovery into the clinical development portfolio. Foster collaboration across multidisciplinary teams to ensure that discovery efforts, platform capabilities including data platforms, and translational priorities are coordinated and integrated.

• Team Leadership & Mentorship: Lead, mentor, and inspire a multidisciplinary team of PhD and non-PhD scientists. Cultivate a culture of scientific excellence, innovation, and collaboration.

• External Engagement: Spearhead collaborations with academic partners and external organizations. Partner with key stakeholders to define publication strategies and support advancement of the company’s scientific reputation in the field.

Required Skills, Experience, and Education:

• Education & Scientific Expertise: Ph.D. in immunology, cancer biology, or a related discipline, with deep expertise in tumor immunology, immune-evasive oncogenic signaling pathways, and/or immunotherapy. Demonstrated track record of excellence in research, evidenced by high-impact publications.

• Industry Experience: 20+ years of post-PhD experience in biomedical research and oncology drug discovery, including substantial experience in biotech or pharmaceutical settings. Demonstrated leadership in oncology drug discovery and development, including experience with antibody-directed therapies such as T cell engagers, ADCs, or bispecific antibodies, is required. Experience setting early discovery strategy is highly desirable.

• Senior Leadership & Organizational Impact: Proven ability to lead complex, multidisciplinary organizations and influence across functions and levels. Demonstrated experience in portfolio decision-making, program governance, and developing scientific leaders.

• Strategic & Analytical Thinking: Enterprise-level strategic thinker capable of prioritizing initiatives, anticipating challenges, and executing effectively in a dynamic, high-energy environment. Rigorous, quantitative, and detail-oriented experimentalist.

• Collaboration & Communication: Thrives in a collaborative, interdisciplinary team setting. Excellent written and verbal communication skills, with the ability to influence and align diverse stakeholders.

Preferred Skills:

• Experience with chemistry-based therapies, including small molecules or ADC payloads.

• Familiarity with bioinformatics-driven discovery and integrating computational insights into experimental design.

• Demonstrated proficiency with modern data platforms, machine learning approaches, and advanced analytics to support Cancer Immunology research and decision-making.

• Prior experience as a Program Team Leader, with a track record of driving cross-functional strategy and execution across discovery and development stages.

 #LI-Hybrid  #LI-LN1

At Oura, our mission is to help people better understand their bodies so they can make healthier, more informed choices every day. With the Oura Ring and app, we translate complex signals about sleep, activity, and readiness into intuitive insights that support long-term health.

We are looking for a Research Scientist to join the Health Science team. This is a deeply collaborative, R&D-oriented role that sits at the intersection of rigorous science and real-world product impact. You will work with large-scale, real-world biobehavioral data — grounded in a mechanistic understanding of human physiology — to drive our end-to-end innovation pipeline, from scientific insight to AI/ML-powered models and cutting-edge analytics that translate complex biology into impactful, scalable product experiences.

You will lead and contribute to research that shapes how Oura understands and serves its members — across sleep, women's reproductive health, cardiometabolic health, and movement — while building the product relationships and scientific foundations that let those insights reach people at scale. You'll work closely with Data Science, Product, Engineering, and Clinical research partners to move ideas from proof of concept to member-facing impact, and to advance the scientific questions that push the field of digital health forward.

What you will do

• Lead and contribute to end-to-end research projects using multimodal physiological and behavioral data — including wearable time-series signals, continuous biomarkers (e.g. CGM), and biological samples (e.g. blood biomarkers) — from hypothesis through analysis to dissemination.
• Design rigorous studies and analyses to answer challenging scientific questions that can move the field forward, across sleep and circadian biology, women's health, cardiometabolic function, and physical activity.
• Develop and apply advanced statistical and computational models (e.g., mixed-effects models, time-series methods, ML/AI approaches) to answer meaningful health questions with real-world, noisy data.
• Translate evidence and research insights into actionable product solutions, helping partners understand what findings mean for members and future features.
• Build and maintain strong working relationships across Health Science, Data Science, and Product squads
• Contribute to external scientific dissemination through abstracts, posters, and peer-reviewed manuscripts, strengthening Oura's scientific credibility and visibility.
• Support literature synthesis and help contextualize findings within current evidence to sharpen research narratives and identify new directions.

We would love to consider you for this role if you have

• A PhD in a relevant field (e.g., bioengineering, data science, biostatistics, neuroscience, biomedical engineering, computer science, exercise science, women's health, or digital health), combined with a degree in a quantitative or computational field — such as computer science, data science, engineering, or biostatistics — at the BS level or above.
• A strong track record of first-authored publications in peer-reviewed journals — particularly work introducing novel concepts, methods, or algorithms — or patent applications, demonstrating the ability to independently drive innovation from conception through to completion.
• Deep hands-on experience with statistical modeling and applied ML in Python or R, particularly with time-series or physiological data, and predictive analytics — for example, forecasting models, classification pipelines, or risk stratification applied to health outcomes.
• Fluency in advanced statistical methods — mixed-effects models, survival analysis, Bayesian inference, or equivalent — and comfort building models that hold up under real-world messiness.
• Demonstrated interest and domain knowledge in at least one of our focus areas: sleep & circadian biology, women's reproductive health, cardiometabolic health, movement and physical activity, longevity, neuroendocrinology, or immune function.
• Experience working with wearable or sensor-based data, digital health platforms, or similar applied data environments.
• Strong product intuition — you understand that rigorous science and practical impact are complementary, not competing, and you enjoy building the relationships that make both possible.
• Creative, hypothesis-driven thinking: the ability to frame new questions, design novel analyses, and operate in ambiguous, exploratory R&D contexts.
• Strong scientific communication skills—able to synthesize results and clearly explain methods, assumptions, and limitations to both technical and non-technical audiences.

Benefits

At Oura, we care about you and your well-being. Everyone here at Oura has a ring of their own and we are continually looking to improve employee health.

What we offer:

• Competitive salary and equity packages
• Health, dental, vision insurance, and mental health resources
• An Oura Ring of your own plus employee discounts for friends & family
• 20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time off
• Paid sick leave and parental leave

Oura takes a market-based approach to pay, which may vary depending on your location. US locations are categorized into tiers based on a cost of labor index for that geographic area. While most offers will be closer to the starting range, successful candidates' pay will be determined based on job-related skills, experience, qualifications, work location, internal peer equity, and market conditions. These ranges may be modified in the future.

• Region 1: $151,300  - $178,000
• Region 2: $138,550 - $163,000
• Region 3: $127,500 - $150,000

A recruiter can determine your zones/tiers based on your US location.

We are not considering candidates residing in the following states: Alaska (AK), Delaware (DE), Iowa (IA), Mississippi (MS), Nebraska (NE), South Dakota (SD), Vermont (VT), West Virginia (WV), and Wisconsin (WI)

What we expect:

• Bachelor’s degree in Computer Science, Information Systems, or related field, or relevant certifications (CISSP, Security+, CEH).
• 5+ years experience in a Customer Success Manager, Technical Account Manager, or related customer-facing technical role.
• 5+ years experience in service delivery or technical account management in post- and/or pre-sales environments.
• Strong communication and presentation skills across technical and executive audiences.
• 3+ years experience in IT, security, healthcare tech, or similar environments.
• Familiarity with network protocols across OT/ICS, biomedical, or traditional IT infrastructures.

• Experience in network engineering, architecture, support, or design.
• Knowledge of healthcare/ICT devices, manufacturers, or applications.
• Experience securing IT, IoT, or healthcare systems.
• Ability to travel up to 20–25% per quarter.

The salary range listed does not include other forms of compensation or benefits (e.g. i.e. bonuses, commissions, stocks, health insurance benefits, etc.) offered to candidates. Visit our careers site for more information on benefits at Armis.

Job Title:  Senior Product Marketing Manager
Employment Status: Full-time
Office Hours: Monday - Friday; hybrid schedule
Location: Boston, Massachusetts
Compensation: $145,000 - $175,000 + variable + equity options
*compensation may be negotiated based on experience level

The role

As a Senior Product Marketing Manager, you'll define and scale how the world understands Ketryx and ensure our story translates into sales wins and customer advocacy. You'll be a master communicator and writer who transforms complex technology into clear, compelling narratives. You'll be the strategic partner our sales team relies on to win deals and the voice that turns our customers into champions.

You'll be joining a company tackling one of the hardest challenges in technology: helping life sciences teams safely and compliantly build regulated products fast. Our platform sits at the intersection of AI, developer tooling, and regulatory infrastructure, serving customers whose products impact hundreds of millions of patients each year. That responsibility and complexity demand excellence, and your job is to demonstrate that Ketryx is the only platform that delivers.

This is a high-visibility, high-impact role where success means transforming complexity into clarity, enablement into revenue, and customers into advocates. You'll work directly with the CMO, Product leadership, Sales leadership, and Customer Success to ensure our narrative is clear, our sales team is equipped to win, and our customers become our best marketers.

About you

You're an exceptional communicator and writer first and foremost. You communicate with precision, clarity, and impact across every format and make complex ideas simple, memorable, and actionable. You think strategically and build frameworks that scale. You're analytical and structured, comfortable leading without authority and influencing senior stakeholders. Your assets are the ones sales teams actually use and customers actually read.

You're a sales enablement expert who knows how to equip teams to win. You've built training programs, battlecards, and playbooks that measurably improved sales performance. You're also skilled at customer marketing and love creating compelling customer stories, building reference programs, and activating advocates.

If you want to shape how the world understands a category-defining product, equip a sales team to win, and turn customers into champions through exceptional communication, we'd love to meet you.

Responsibilities

• Shape how Ketryx shows up in the market. Own messaging and positioning that transforms complex technology into clear, compelling narratives that differentiate and resonate.
• Build the sales enablement engine. Create battlecards, training programs, and playbooks that equip our sales team with the confidence and tools to win consistently.
• Drive customer marketing and advocacy. Develop compelling case studies, build reference programs, and activate customers as champions who amplify our story.
• Bring new products and features to life. Partner with Product, Sales, and Demand Gen to execute launches that create buzz, generate pipeline, and drive adoption.
• Keep us sharp on the market. Research customers, competitors, and industry trends to uncover insights that shape our messaging, product strategy, and positioning.
• Measure what matters. Track and report the impact of enablement, launches, and customer programs, connecting your work directly to revenue growth and market momentum.

Required Skills

• Exceptional writing and communication skills - ability to produce clear, compelling, and technically accurate content across formats (decks, web pages, case studies, training materials, battlecards, blogs).
• 7+ years of product marketing experience - ideally 5+ years in B2B SaaS, with demonstrated progression to senior or lead-level ownership.
• Sales enablement expertise - built and delivered enablement materials with clear, measurable impact on sales performance.
• Strong technical storytelling ability - translates complex, technical, or regulated concepts into simple, differentiated market narratives.
• Process-builder mindset - experience creating scalable product marketing frameworks, templates, and operating rhythms from scratch.
• Data-informed decision making - uses customer, market, and performance insights to refine messaging and go-to-market strategy.
• Execution ownership in high-velocity environments - consistent track record of driving projects end-to-end in startup or fast-growing companies.

Preferred Skills

• Strongly Preferred: STEM background or proven knowledge or experience in one of the following:
• Life Science SaaS
• Software/Product Lifecycle Management
• Software testing / Verification and Validation
• Artificial intelligence (AI/ML)
• Cybersecurity
• Medical device or software as a medical device (SaMD)
• Experience with sales enablement platforms (Highspot, Seismic, Gong, Chorus).
• Experience building customer advisory boards or reference programs at scale.
• Public speaking or webinar moderation experience.
• Experience working in an early stage, product-based start up.

Keywords: Technical product marketing, product marketing manager, healthcare technology, medical devices, AI/ML, FDA regulations, software validation, B2B SaaS marketing, solutions engineering, life sciences, medical device software, regulatory compliance, go-to-market strategy, healthcare software, biomedical engineering

Job Title: Product Marketing Manager
Employment Status: Full-time
Office Hours: Monday - Friday; hybrid schedule
Location: Boston, Massachusetts
Compensation: $110,000 - $120,000 + variable + equity options
*compensation dependent on related experience level

About Ketryx:

Ketryx is an AI software platform that enables healthcare life sciences companies to ship life-saving regulated products in weeks instead of years.

Exploding product complexity is burying companies in compliance paperwork and blocking innovation. Our AI software removes this friction, dissolving the historical tradeoff between innovation and compliance, and enables regulated industries to innovate at the pace of modern software.

Just two years since launch, Ketryx already touches the lives of 25M patients and powers 3 of the world’s top 5 MedTech companies and 25% of the Fortune 500 MedTech market. Backed by Lightspeed Ventures, our founders are the former Head of AI at Amgen and CTO of Wolfram Cloud.

Healthcare and life sciences is just the beginning for us. Automotive, aerospace, energy — if it’s regulated, it’s because society decided it matters. These products move humanity, shape our future, and are safety-critical. Come join us and help build the AI platform to power safe innovation.

About the Role:

As a Product Marketing Manager, you’ll define how the world understands Ketryx. You’ll shape our story, translating complex technology into clear and compelling narratives that drive the go-to-market strategy, campaigns, and product launches. 

You’ll be joining a company tackling one of the hardest challenges in technology: helping life sciences teams safely and compliantly build regulated products fast. Our platform sits at the intersection of AI, developer tooling, and regulatory infrastructure, serving customers whose products impact hundreds of millions of patients each year. That responsibility and complexity demand excellence, and your job is to demonstrate that Ketryx is the only platform that delivers.

This is a high-visibility, high-impact role where success means transforming complexity into understanding, and understanding into adoption. By joining the product marketing team, you’ll have the support of a team of subject matter experts and the runway to build repeatable playbooks that scale as we grow.

Responsibilities:

• Shape how Ketryx shows up in the market. Transform complex concepts into clear, compelling messaging and positioning.
• Bring new products and features to life. Partner closely with Product, Sales, and Demand Gen to plan and execute launches that create real buzz and generate pipeline.
• Create content that drives action and thought leadership. Build the decks, one-pagers, web pages, webinars, and case studies that bring our story to life, fuel sales conversations, and strengthen Ketryx’s leadership.
• Empower our go-to-market teams. Build and deliver training, playbooks, and enablement materials that give BDRs and AEs confidence, clarity, and the tools to win.
• Keep us sharp on the market. Research customers, competitors, and industry trends to uncover insights that shape our messaging, product strategy, and positioning.
• Measure what matters. Track and report the impact of launches, content, and enablement initiatives, connecting your work directly to revenue growth and market momentum.

Required Skills:

• 5+ years of experience in product marketing or product management with 3+ years in B2B SaaS environment
• Experience developing clear, audience-specific messaging and product narratives that translate complex, technical, or regulated concepts into simple, compelling stories.
• Experience designing and delivering effective sales enablement, including competitor battlecards, objection handling, sales presentations, and training.
• Proven track record using data and market insights to refine messaging and strategy
• Hands-on experience building a range of marketing assets, sales presentations, demo videos, 1-pagers, web pages, blogs, and webinar content.
• Consistent track record in defining/driving project execution in a start-up environment.

Preferred Skills:

• Strongly Preferred: STEM background or proven knowledge or experience in one of the following:
• Life Science SaaS
• Software/Product Lifecycle Management
• Software testing / Verification and Validation
• Artificial intelligence (AI/ML)
• Cybersecurity
• Medical device or software as a medical device (SaMD)
• Experience working in an early stage, product-based start up.

Keywords: Technical product marketing, product marketing manager, healthcare technology, medical devices, AI/ML, FDA regulations, software validation, B2B SaaS marketing, solutions engineering, life sciences, medical device software, regulatory compliance, go-to-market strategy, healthcare software, biomedical engineering

We’re looking for a Hardware R&D Research Intern to join our Research Operations team in San Francisco, with a dedicated focus on hardware research programs. Our Research Operations team designs and executes the human research studies that power Oura’s next-generation sensor development and scientific innovation and bolster our scientific credibility. The focus of the hardware research program is to develop and validate new features and continue to enhance the accuracy of our algorithms.

As a Hardware R&D Research Intern, you’ll support internal and external human research studies that help develop and validate new Oura hardware and sensing capabilities. You’ll get hands-on experience across the study lifecycle — from equipment prep and lab setup to data collection and data quality checks.

This is a full‑time summer internship based in San Francisco, CA, with on‑site work required 5 days/week for data collection and lab activities. The internship duration is 3–4 months, with flexible start and end dates between May and September 2026.

What you will do

• Support hardware‑focused human studies: Assist with 1-2 hardware and sensing research studies under the guidance of Research Coordinators and Research Project Managers.
• Prepare and maintain research equipment
• Assist with setting up research equipment for both internal and external hardware research studies.
• Perform equipment checks before sessions (battery status, firmware/app versions, connectivity, storage).
• Help track and organize research equipment inventory, including labeling, storage, and basic troubleshooting.
• Support study documentation and data quality checks
• Contribute to protocols, standard operating procedures (SOPs), and checklists for study visits and equipment handling
• Assess and flag quality concerns related to device signals (e.g., missing data, motion artifacts, device non‑wear, connectivity issues)
• Contribute to simple data review summaries (e.g., dashboards, spreadsheets) to monitor study progress
• Collaborate with cross‑functional partners (e.g., Research Operations, Hardware, Data Science) to keep documentation organized and up to date

Requirements:

We’d love to hear from you if you are a current undergraduate student who:

• Is studying biomedical engineering, electrical engineering, human biology, neuroscience, physiology, computer science, or a related field
• Has experience or coursework related to human subjects research, lab work, or experimental design
• Is excited about a future career in wearable technology, sensors, and hardware R&D
• Is comfortable working hands‑on with electronic devices and lab or test equipment
• Demonstrates strong attention to detail and a commitment to high‑quality documentation
• Is proficient with Google Workspace tools and comfortable using iOS and/or Android devices
• Is based in or able to be in San Francisco, CA for the summer and available for regular on‑site work for data collections

This is a paid opportunity to work with a dynamic team and gain valuable experience in the health tech industry. You will also receive an Oura Ring of your own to keep. Oura takes a market-based approach to pay, which may vary depending on your location. US locations are categorized into tiers based on a cost of labor index for that geographic area. While most offers will be closer to the starting range, successful candidates' pay will be determined based on job-related skills, experience, qualifications, work location, internal peer equity, and market conditions. These ranges may be modified in the future.

• Compensation range: Region 1: $33-$36/hr 

If you're interested in this opportunity, please submit your resume and cover letter for consideration.

The Opportunity:

As a Scientist II in the Cancer Pharmacology team within the Translational Research group, in the Biomedical Discovery Research Department, you will:

• Contribute to advancing RAS(ON) inhibitor programs by applying cancer pharmacology and tumor biology expertise, with a focus on mechanistic understanding of RAS biology.

• Design, execute, and interpret in vivo efficacy and PK/PD studies (internally and via CROs) to support forward and reverse translation of RAS(ON) inhibitors

• Collaborate with the cross-functional quantitative modeling group, providing data, biological context, and critical evaluation to support translational PK/PD modeling (no requirement for hands-on mathematical model experience).

• Analyze, interpret, and communicate data clearly to internal teams and external scientific audiences.

• Maintain high-quality documentation, protocols, and data integrity.

Required Skills, Experience and Education:

• Ph.D. in pharmacology or cancer biology, or a related discipline with direct relevance to oncology drug development.

• 2+ years of relevant postdoc or industry experience in cancer drug discovery and development.

• Solid knowledge of tumor biology and RAS signaling pathways

• Demonstrated experience in designing, executing and analyzing in vivo experiments with oncology disease models.

• Working knowledge of PK and PK/PD relationships, with the ability to analyze and interpret data.

• Rigorous and detail-oriented with proven excellence in experimental design, data analysis, data management, and presentation.

• Excellent written and verbal communication skills. Able to effectively communicate results to non-specialist and specialist audiences.

• Thrives in a collaborative team setting and is driven by a desire to be innovative in a dynamic and fast-paced environment.

Preferred Skills:

• Familiarity with RAS biology and RAS-targeted therapies

• Experience with designing and executing PKPD studies in tumor models.

• An understanding of preclinical to clinical translational concepts desired.

• Strong track record of research productivity as evidenced by high-quality, impactful publications.

• A strong theoretical understanding of the core concepts, assumptions, and limitations associated with PK/PD mathematical modeling.

#LI-Hybrid   #LI-NE1

We are currently seeking an Industrial / Process Architect to join our Raleigh office. In this role, you will play a pivotal role in growing our pharmaceutical manufacturing business. You possess experience in planning and design for the life sciences realm, specifically in biotechnology, pharmaceutical, biomedical or other process architecture. You are passionate about design and devoted to quality. You possess the organizational skills to prioritize tasks and handle multiple deadlines, a thorough knowledge of relevant codes, operations, processes and trends, a demonstrated ability to mentor and manage teams, and foster and nurture Client relationships. 

Since its inception in 2014, Roivant Sciences has sought to improve health by rapidly delivering innovative medicines and technologies to patients. We’ve employed a unique, decentralized model of nimble, focused companies (‘Vants’) focused on various therapeutic areas and built around the pursuit of innovation in drug development and technology.

Our model is different. Five new medicines have been approved off the Roivant platform; we’ve built five biotechs that have become public; we’ve created well over $1b in value in Roivant Health in just six years.  Our successes have ranged from computational drug discovery to tokenized healthcare data exchange, and from novel topicals for dermatological conditions to ultrarare tissue therapies.

Roivant Health is Roivant’s platform for the creation of new technology Vants, focused on delivering improvements to human health outside of our traditional biotech platform.  In six years since inception, we’ve created eight enduring companies and over $1B in enterprise value, including the leading deidentified healthcare data exchange platform (Datavant) and a top-tier computational drug discovery company (VantAI) which has partnered with Johnson & Johnson, Bristol-Myers Squibb, and Boehringer Ingelheim. Our goal is to improve human health by rapidly discovering, developing and delivering innovative medicines and technologies to all patients. Our success is predicated on attracting and retaining top talent, generating new ideas and promoting an open and collaborative culture.

We embrace diversity across all dimensions and levels of the organization, and we strive to ensure every employee is supported in reaching their full potential. We hire motivated people with diverse backgrounds, identities, experiences and skillsets. We are committed to fostering an inclusive culture where all employees feel valued, respected and empowered to create value for patients.

Summary:

Roivant is seeking a Founding Engineer to work on the core technology underpinning new healthcare and life sciences companies. You’ll partner with business, operational, product, and/or clinical leaders to rapidly de-risk, prototype and productize new software, working at the intersection of AI, data engineering, and real-world biomedical data. This is a hands-on, highly entrepreneurial role ideal for a talented software engineer who wants to build groundbreaking health AI products.

Responsibilities:

• Contribute to technical strategy for new company formation, including scoping early technical feasibility, identifying data and infrastructure needs, and building initial proof-of-concept systems
• Design, build, and iterate on tooling, infrastructure, and workflows to run AI/ML training and inference workloads at scale across varied health × AI applications
• Develop and refine data and model pipelines that integrate multimodal health data (e.g., clinical text, omics, imaging, sensor data, etc.) for downstream AI/ML tasks
• Collaborate closely with domain experts and business stakeholders to incorporate client and commercial insights into model design and deployment

Qualifications:

• Experience building and deploying ML or AI systems in production
• Strong Python engineering skills with experience in building scalable, testable codebases
• Comfort working in fast-paced, high-ambiguity environments where requirements evolve

We are deep believers in rapid career advancement for high performers and take a flexible approach to role design, adjusting responsibilities based on individual strengths. The ideal candidate is ambitious, entrepreneurial, and comfortable with ambiguity, driven by a passion for building transformational healthcare technology. We seek individuals who embrace calculated risk-taking as essential to achieving meaningful outcomes for patients.

Base salary for this role will be determined during the interview process and will vary based on multiple factors, including but not limited to prior experience, relevant expertise, current business needs, and market conditions. The expected base salary for the role will generally be between $130,000 to $180,000 per year at the commencement of employment, but the final salary offered may be outside this range based on individual circumstances and business and market conditions. 

Base salary if hired is only part of the total compensation package, which, depending on the position, may also include other components such as discretionary bonuses, equity, and Company-sponsored benefit programs.

This position is at-will and Roivant reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance and business and market conditions.

Roivant Sciences provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

The Opportunity:

As an Executive Director and Head of Research Computational Biology within our Biology Function, the individual will oversee the scientific and strategic direction of systems biology research and preclinical computational biology initiatives. The individual will lead a team of computational biologists and bioinformaticians focused on acquisition, organization, and analysis of large multi-omics data sets, using both public and proprietary data sources, that will help inform treatment strategies and guide patient stratification for a growing pipeline of RAS(ON) and targeted oncology therapeutics. We are looking for an experienced leader with strong interpersonal skills and an ability to lead a strong and diverse computational biology team. Key aspects of the role include:

• Strategic vision and leadership: Develop and implement a long-term strategy for research systems biology and bioinformatic activities to support a growing pipeline of RAS(ON) and novel targeted inhibitors. Lead and supervise a team of experienced computational biologists and bioinformaticians to generate, organize, and interpret large data sets to inform therapeutic and combination strategies for patients with cancer.

• Cross-functional collaboration across research, translational, development and medical affairs groups: Work across functions to support advancement of programs from early discovery into clinical development using biological insights derived from computational approaches. Additionally, leverage clinical data from RVMD investigational agents to generate proprietary insights into RAS mutant tumor biology and RVMD RAS(ON) inhibitor mechanisms of action.

• Technical leadership and innovation: Lead a team analyzing large, high-dimensional datasets. Work with colleagues in Information Sciences and Information Systems to oversee data integration, analysis and visualization using cloud-based platforms (AWS, Azure, GCP). Direct the development and application of cutting-edge statistical analysis, AI/ML methods, generative AI models, and MLOps principles to elucidate findings and generate new insights related to biomarker discovery, drug target identification, and predictive modeling. Establish and implement modern workflow management systems (Snakemake, Nextflow) and reproducible research practices.

• External collaboration: Cultivate and manage academic and industry collaborations, including CRO partnerships. Represent the company at scientific conferences through presentations and thought leadership. Maintain an active publication record in high-impact, peer reviewed journals. Drive intellectual property strategy and patent filings related to computational discoveries.

Required Skills, Experience and Education:

• Education: A Ph.D. in systems biology, computational biology, bioinformatics, or a related biological or biomedical discipline.

• Experience: Minimum of 15+ years total experience with significant pharmaceutical/biotechnology industry and management experience.

• Scientific knowledge: Deep expertise in systems biology, computational biology, and bioinformatics, including proficiency with multi-omics data integration, modeling, and analysis. Experience with single-cell technologies, spatial transcriptomics, proteomics, and epigenomics. Oncology research experience preferred but not required.

• Technical: Advanced programming skills in R, Python, and at least one additional language (Perl, C/C++, Java). Proficiency with high-performance computing (HPC) and cloud platforms (AWS, Azure, or GCP). Knowledge of workflow management tools and version control systems. Understanding of MLOps principles, model deployment, and generative AI applications in drug discovery.

• Leadership and management: Demonstrated ability to lead, mentor, and inspire interdisciplinary teams while fostering a collaborative culture. Experience managing budgets and strategic planning at the department level. Proven track record of advancing research programs from discovery through development.

• Strategic thinking: Proven strategic thinker who can align research and drug development objectives and leverage innovative technologies effectively.

• Communication: Excellent communication and presentation skills for interacting with technical teams, senior leadership, and external partners. #LI-Hybrid  #LI-GL1

The Opportunity:

The Translational Sciences Intern will support the Translational Sciences team in advancing programs that connect preclinical discovery with clinical development. This role provides exposure to how Translational Research integrates molecular biology, pharmacology, biomarker discovery, and clinical data to inform therapeutic development in precision oncology. The intern will gain insight into how translational strategies are developed to understand drug mechanisms, identify biomarkers of response and resistance, and guide clinical trial design. This position is ideal for a student interested in translational cancer research and the interface between laboratory science and clinical application. The role focuses on learning, analysis, and cross-functional collaboration within a multidisciplinary drug development environment.

This role provides the opportunity to learn some or all the following, depending on project assignments and team needs.

• How translational research supports the development of targeted therapies in oncology.

• How biomarker strategies are developed to support clinical trials and precision medicine approaches. • How preclinical data are integrated with clinical observations to understand mechanisms of response and resistance.

• How cross-functional teams across discovery biology, pharmacology, clinical development, and bioinformatics collaborate in drug development.

• How experimental and clinical datasets are analyzed and interpreted to generate translational insights.

• How translational scientists communicate complex scientific findings to multidisciplinary teams.

Required Skills, Experience and Education:

• Strong analytical, critical-thinking, and problem-solving skills.

• Ability to interpret scientific literature and synthesize complex scientific information.

• Strong written and verbal communication skills.

• Interest in oncology, molecular biology, or translational research.

• Organized, detail-oriented, and able to work independently with guidance.

• Professional curiosity and willingness to learn new concepts.

• Pursuing a bachelor’s or master’s degree in a STEM field (e.g., biology, biochemistry, molecular biology, biomedical engineering, or related discipline).

Preferred Skills:

• Coursework or research experience in cancer biology, molecular biology, or pharmacology.

• Familiarity with biomarker concepts or translational research approaches.

• Experience with basic laboratory techniques or biological data analysis.

• Experience preparing scientific presentations or summarizing research findings.

• Interest in precision medicine and targeted cancer therapies. 

  #LI-Hybrid  #LI-AP1

The Opportunity:

We are seeking a highly capable Associate Director of Biostatistics to join our Medical Analytics and Exploratory Data Science Biostatistics group within our Biostatistics organization. This role will play a critical part in the design, analysis, and interpretation of exploratory data analyses, scientific publications, real-world evidence (RWE), post-marketing research, and health economics and outcomes research (HEOR) studies. The successful candidate will serve as a key statistical contributor and emerging leader, partnering closely with cross-functional teams to deliver high-quality, data-driven insights that support scientific understanding and evidence generation.

• Lead statistical design, analysis, and interpretation for exploratory data analyses using existing clinical trial data, real world data studies, post-marketing research, and HEOR projects.

• Partner closely with other subfunctions within quantitative sciences and with cross-functional teams, including clinical development, medical affairs, safety, statistical programming, regulatory affairs and commercial, to execute evidence generation plans.

• Apply appropriate statistical methodologies, including survival analysis, machine learning, and casual inference approaches, to address complex scientific and medical questions in oncology.

• Contribute to the development of analysis plans, technical specifications, and interpretation of results under general direction from senior statistical leadership.

• Support cross-functional evidence generation planning by providing statistical input into study design, feasibility, and analysis strategies.

• Review and oversee statistical deliverables produced by internal programmers or external vendors/contractors to ensure scientific quality and consistency with standards.

• Contribute to and implement policies, standards, and procedures to ensure consistency and quality in statistical practices.

• Assist with the preparation of scientific communications, including abstracts, manuscripts, posters, and internal presentations.

Required Skills, Experience and Education:

• Ph.D. or M.S. in Statistics/Biostatistics, a minimum of 5 years (for Ph.D.) and 8 years (for M.S.) of experience in biotech/pharma industry as a statistician.

• Solid knowledge of statistical methodologies for oncology, including survival analysis and causal inference.

• Hands-on experience in exploratory analysis of oncology trials.

• Ability to work independently and within a team.

• Ability to independently execute statistical analyses for moderately complex projects with guidance from senior statisticians.

• Familiar with regulatory requirements related to biostatistical activities and clinical trials.

• Strong verbal and written communication skills are required.

• Strong interpersonal and project management skills are essential.

• Proficiency in SAS and/or R.

Preferred Skills:

• Knowledge of RWD and health economics and outcomes research (HEOR) in oncology is a plus.

• Familiarity with machine learning or advanced modeling approaches applied to biomedical or observational data. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

We are seeking a highly motivated and scientifically rigorous Director of Biostatistics to our Medical Analytics and Exploratory Data Science Biostatistics group. This role will provide strategic and hands-on statistical leadership for exploratory data analyses, scientific publications, real-world evidence (RWE), post-marketing research, and health economics and outcomes research (HEOR) initiatives. The successful candidate will serve as a key statistical leader and individual contributor, partnering closely with cross-functional teams to generate high-quality evidence that advances our oncology pipeline and supports medical and scientific strategy.

• Provide statistical leadership for exploratory data analyses using existing clinical trial data, real world data studies, post-marketing research, and HEOR projects.

• Serve as a primary statistical contact for assigned projects, working collaboratively with clinical development, medical affairs, safety, statistical programming, regulatory affairs and commercial.

• Lead the design, analysis, and interpretation of complex statistical models, including survival analysis, machine learning, and casual inference methodologies.

• Contribute to and implement policies, standards, and procedures to ensure consistency and quality in statistical practices.

• Manage relationships with external partners, such as contract research organizations (CROs), ensuring adherence to timelines, budgets, and quality standards.

• Mentor and provide technical guidance to junior statisticians, fostering scientific rigor, innovation, and professional growth.

• Contribute to regulatory and payers/HTA agencies interactions, scientific publications, abstracts, and internal decision-making through clear and effective communication of statistical results.

Required Skills, Experience and Education:

• Ph.D. or M.S. in Statistics/Biostatistics, a minimum of 8 years (for Ph.D.) and 12 years (for M.S.) of experience in biotech/pharma industry as a statistician.

• Solid knowledge of statistical methodologies for oncology, including survival analysis and causal inference.

• Hands-on experience in exploratory analysis of oncology trials.

• Proven ability to independently lead statistical aspects of complex, cross-functional projects.

• Strong understanding of regulatory requirements related to biostatistical activities and clinical trials.

• Excellent verbal and written communication skills are required.

• Excellent interpersonal and project management skills are essential.

• Proficiency in SAS and/or R.

Preferred Skills:

• Knowledge of RWD and health economics and outcomes research (HEOR) in oncology is a plus.

• Familiarity with machine learning or advanced modeling approaches applied to biomedical or observational data. 

  #LI-Hybrid  #LI-SH1

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. 

You will make an impact:   

As the Senior Technical Project Manager, you will be responsible for ensuring the delivery of quality products and services to eClinical Solutions’ clients and partners. You will oversee the successful delivery of eClinical Solutions’ elluminate product, a next generation data integration and analytics cloud platform that enables life sciences organizations to optimize the aggregation, standardization, and analysis of their data throughout the clinical development lifecycle. You will develop roadmaps and timelines for executing the highest quality of technical services and support including but not limited to solution integration, custom reporting, data mapping and Clinical Data Repository. You are responsible for developing and maintaining detailed project documentation, managing client expectations and approvals on scoped deliverables, balancing and reconciling the project budget, serving as the point person for project communication and issue escalation, effectively realigning resources in response to scope changes and proactively mitigating other potential risks, fostering positive and long-lasting client relationships, driving elluminate utilization, and driving project efforts toward successful (on time, on budget, within scope) completion.  

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.  

Your day to day: 

• Independently lead and drive elluminate implementation projects throughout the project lifecycle by consistently using PMI-compliant and eClinical Solutions-required methodologies, standards, and best practices 
• Successfully manage multiple software implementation projects simultaneously, ensuring that proper documentation is developed and maintained, that project risks are mitigated with a collaborative team approach and that client satisfaction remains at the forefront of all efforts 
• Collaborate with internal and external subject matter experts to deliver seamless elluminate integration, rapid system adoption and end-user utilization, and the highest quality of professional services to our clients 

Take the first step towards your dream career. Here is what we are looking for in this role.  

Qualifications: 

• Bachelor's degree preferred, in a health sciences or analytic discipline  
• 5+ years of systems/software project management experience in a clinical, biomedical, or software environment 
• Clinical data management experience preferred 
• Exceptional multi-tasking and time management skills, including the ability to effectively resource competing priorities and adapt to changing client demands 
• Excellent written and verbal communication skills and an ability to effectively partner with audiences at all levels of the eClinical Solutions and client organizations 
• Commitment to utilizing operational standards, PMI methodologies and best practices with a focus on process efficiencies and revenue growth opportunities 
• Proficient with Microsoft applications (Word, Outlook, Excel, PowerPoint, Project, Visio, Teams, etc.) and collaborative platforms like MS Teams, OneDrive, and SharePoint 
• Experience managing client projects that focus on technical deployments, system implementations, and/or data management and reporting 
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trials methodology, CRO partnerships, and EDC systems (Medidata, Rave)  

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!

eClinical is a winner of the 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. See all the details here: https://topworkplaces.com/company/eclinical-solutions/

eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

About ProBio:

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017.

Job Scope:

This position is responsible for coordinating and overseeing facility outside services, engineering and construction capital projects for GXP & non-GMP facilities in New Jersey. This role will focus on working with external engineering design firms, construction contractors, landlords, and government offices, as well as all internal departments.

Essential responsibilities:

• Manage multiple facility outside services, engineering and construction projects ranging from $0.05MM to $30MM at any given time.
• Direct day-to-day activities of project team to achieve the following for each project:
• Log and track action items through project lifecycle.
• Bid, award, and select engineering firms, construction firms, equipment vendors, CQV consultants, and service contractors.
• Ensure that user requirement specifications are appropriately met through high quality project deliverables.
• Develop and maintain a project schedule to foster accountability and note staffing requirements.
• Manage project capital budget, ensuring on-time and under-budget project completion. Ensure that POs and contracts are issued within budget and company standards.
• Review and process change orders in accordance with contract requirements.
• Prepare project updates and budget release presentations to be provided to upper management teams.
• Build partnering relationships with project executives, landlords, contractors, and consultants.
• Host Gemba Walks and track observations correction to fulfill continuous site improvement.
• Execute and manage site-wide controlled drawings program. Complete physical verification, redline, correction, and control of drawings required for qualification activities.
• Establish and maintain site security program. Assign new badges, control security clearances, and rectify security incidents.

Qualifications

• Bachelor’s or advanced degree in Construction Management, Mechanical Engineering, Biomedical Engineering, or other Engineering capacity.
• Strength in managing facility & construction projects for facilities in the pharmaceutical industry.
• Experience in project management and engineering practices. PMP or similar project management certification is preferred.
• Familiarity with estimating and bidding
• Experience in negotiating with landlord, government regulation offices, and engineering/construction contractors.
• Understanding of manufacturing processes for plasmid DNA and viral vectors in the cell & gene therapy industry.
• Possess strong written and communication skills.
• Proficient in Auto Cad & Microsoft Project highly desired.

The estimated pay range for the role is between $100000 - $120000 depending on experience and skill set

# LW

# PB

Job Title: Construction Project Manager

Location: Piscataway, NJ (Fully onsite)

Reports to: Director of US Site Operations

Compensation: The estimated salary range is $120,000 - $150,000, based on experience. 

Overview: 

GenScript is seeking a talented, detail oriented and self-driven individual to join the Operations Department, contributing to the planning, design, construction, commissioning, validation, and engineering process systems development for our facilities in Piscataway, NJ. This position is valid for at least 1-2 years with the opportunity to transition to facility manager after the construction projects are done.

Job Responsibilities: 

Project Planning and Execution: 

• Develop comprehensive project plans ensuring projects proceed according to set objectives, including requirement gathering, feasibility analysis, risk assessment, and solution formulation.
• Manage cost estimation for all project phases and create cost control plans.
• Procurement and Contract Management.
• Oversee bidding and procurement for project design, construction, and long-lead equipment.
• Manage contract signing and execution with suppliers and contractors, ensuring compliance with terms, quality, and deadlines.

Compliance and Regulatory Affairs: 

• Plan and execute government and third-party procedures to ensure project compliance with US regulations.
• Plan and manage government permits applications.

Project Management: 

• Manage technical, quality, safety, and timeline aspects of projects, ensuring timely resolution of technical issues, compliance with quality standards, and implementation of safety measures.
• Coordinate with construction firms, supervisory, and contracting units to manage internal and external project relationships.
• Commissioning and Validation:
• Organize factory acceptance tests, commissioning, and validation to ensure systems meet user requirements.

Project Completion: 

• Lead the final inspection, handover, documentation review, and project settlement activities, ensuring successful project completion and handover.
• Reporting and Improvement:
• Regularly report project progress, compile project reports, analyze lessons learned, and suggest improvements.

Qualifications and Requirements

Education and Experience: 

• Bachelor's degree or higher in Mechanical/Electrical, Chemical Engineering, Biomedical Engineering, or related fields.
• 10+ years of experience in biopharmaceuticals with substantial project management and facility operations experience.
• Hands on experience in managing construction, experience in executing projects from business requirement collection through to design, construction, commissioning, validation, and final settlement is preferred.

Skills: 

• Strong management and reporting capabilities, clear management vision, able to handle high-pressure work environments.
• Solid technical expertise combined with engineering knowledge.
• Demonstrated skills in problem solving, root cause analysis with result driven thought process.

Additional Considerations: 

• Proficient in project management software (e.g., Procore, Microsoft Project, Primavera P6).
• Familiarity with construction estimating and scheduling tools.
• Understanding of US building codes, zoning laws, safety regulations, and biopharmaceutical industry standards.

#LI-EB1

#GS

About the Role

Reporting to the Sr. Director, Pharmaceutical Sciences, the Associate Director, Pharmaceutical Sciences (Drug Delivery) will lead and execute innovative drug delivery and formulation strategies to support pre-IND product development, candidate selection, and novel delivery platform advancement. The incumbent will drive scientific and technical direction for formulation & delivery approaches across modalities, strengthen the company’s IP portfolio, and collaborate with cross-functional teams (Innovation Lab, Translational Sciences, Pharmaceutical Development, Analytical Development) to enable successful transition from concept to candidate selection.

Let’s talk about some of the key responsibilities of the role:

• Develop and lead delivery sciences strategy for new and emerging modalities (small molecules, biologics, peptides)
• Identify white space opportunities and contribute to invention disclosures and patent strategy in partnership with IP counsel.
• Evaluate competitive landscape and emerging delivery technologies to inform internal innovation strategy.
• Design, execute, interpret laboratory results to develop and optimize novel drug delivery systems, and define data-driven next steps to drive platform development.
• Generate formulation and delivery approaches to enable pre-clinical animal models.
• With the Translational Sciences team interpret in vitro and in vivo data (PK/PD, bio-distribution, tolerability) to refine and prioritize delivery strategies.
• Represent delivery sciences in program governance and external partnerships.
• Serve as scientific lead for external CRO partnerships.
• R&D project budget planning and budget management.
• May perform other related duties as required and/or assigned.

Factors for Success:

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Biomedical Engineering, or related field.
• Minimum of 8 years of relevant experience in drug delivery and developing novel drug delivery platforms from concept through preclinical validation.
• Experience managing CROs and external research collaborations.
• Strong experimental design, data interpretation, and problem-solving skills.
• Track record of platform innovation and contribution to patents in drug delivery.
• Excellent communication skills with ability to present complex technical concepts clearly to diverse stakeholders.
• Strong leadership skills and experience in cross-functional project leadership.
• Tarsus Competencies:
  • Decision Making - Demonstrates strong decision-making by applying structured analysis to complex challenges, balancing competing priorities and long-term impacts while engaging stakeholders and driving solutions aligned with organizational goals.
  • Collaboration and Team Building - Promotes collaboration by aligning diverse teams around shared goals, fostering healthy debate to advance outcomes, and building strong networks that strengthen organizational effectiveness and cross-team learning.
  • Outcome Driven - Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results.

 A Few Other Details Worth Mentioning:

• The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals. We provide a hybrid work environment.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to our Sr. Director, Pharmaceutical Sciences.
• Some travel may be required – up to 20%.

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $150,000 - $210,000 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.

#LI-Hybrid

What you’ll do:

• Design and build reliable automated test equipment to conduct functional tests on PCBAs or modules.
• Work together with Design Engineers, System Engineers, and Reliability Engineers to Identify design critical operating modes and create design validation test plans.
• Work with test technicians to build validation test setups and execute test plans and teardowns.
• Investigate device failures to determine root cause and drive product improvements.
• Identify and plan critical tests to validate new technologies.  

What you’ll need:

• Bachelor or MS degree in Electrical Engineering or equivalent experience.
• 2+ years of experience with physical testing and analysis of mechanical or electronic systems against detailed requirements. 
• 2+ years of direct automation design and build experience (automated testing, manufacturing, robotics, industrial etc.)
• Experience leading and driving technical projects to completion.
• Good understanding of electrical circuit design and  power electronics.
• Experience with Python and NI(LabVIEW, TestStand, or VeriStand).
• Experience with electrical test equipment, hand tools, power tools. 

Bonus Qualifications:

• 2+ years of experience with component, system, or vehicle validation testing (FAA DO160, Biomedical FDA testing, or equivalent.) 
• Good Electrical Engineering Background (active circuit design, power electronics, digital circuits, motor drives, signal measurement and conditioning)
• Experience working with interdisciplinary teams across an organization.
• Strong communicator and presenter of technical content.
• Experience using CAD software to create basic fixtures.
• Experience with HV systems and safety.
• Experience with integrated system communication protocols (CAN, Ethernet, RS485 etc.)

About this Role

As Director, Mechanisms Engineering - Pharmaceutical Payloads at Varda, you will build and lead the team responsible for Varda's in-orbit pharmaceutical manufacturing payloads—the core of Varda's commercial business. This role combines deep technical authority with team leadership, product definition, and development execution responsibility. You will own the successful development and flight of precision electromechanical fluid-handling systems that process and crystallize pharmaceutical compounds in microgravity—then survive hypersonic reentry and return to Earth for product recovery and hardware iteration. The payloads your team designs, builds, and flies will directly determine whether in-space pharmaceutical manufacturing becomes a commercial reality.

You will build and grow a team of payload engineers responsible for individual pharmaceutical payload missions while also owning the technical definition and evolution of Varda's pharma payload product line. This includes defining the system architecture, fluid system design philosophy, and development approach, and establishing the engineering standards and processes that enable reliable execution as Varda scales in both cadence and scope.

You'll expand Varda's pharmaceutical payload capability to a scaled, repeatable product line—building the team, technical standards, and development processes to get there.

This role is ideal for a technically exceptional leader who wants to build an elite team and own the first ever industrial manufacturing capability in space from strategy through execution.

Responsibilities

• Build and lead a team of payload engineers, each responsible for executing individual pharmaceutical payload missions
• Mentor engineers and develop future technical and people leaders
• Own the pharmaceutical payload development roadmap—expanding Varda's pharmaceutical product portfolio, driving design iteration from flight data, and scaling mission cadence
• Own pharmaceutical payload engineering execution against company goals and customer contracts, including schedule, cost, and technical performance
• Manage a portfolio of concurrent payload development efforts and recurring mission executions, ensuring schedule, technical performance, and engineering quality across the portfolio
• Define and maintain standards for payload design, analysis, integration, testing, mission execution, documentation, and project management
• Work closely with avionics, software, thermal, systems, integration, and vehicle teams to define payload interfaces and constraints
• Standardize processes for environmental test campaigns, mission operations, post-flight hardware inspection, and anomaly resolution
• Drive continuous improvement through lessons learned and feedback from flight programs

Basic Qualifications

• BS/BEng in Mechanical, Aerospace, Biomedical, Mechatronics, or a related engineering discipline
• 10+ years of experience designing, integrating, testing, and delivering complex electromechanical hardware involving precision fluid handling
• 3+ years of experience leading teams through full-cycle hardware development
• Experience with electromechanical fluid systems in high-reliability or extreme environments (space, life support, medical devices, semiconductor process equipment, bioprocess systems)
• Breadth across at least two adjacent hardware disciplines (e.g., avionics, mechanisms, software, structures, thermal, optics, test, etc.)
• Demonstrated ability to set technical direction and deliver results through other engineers
• Track record managing multiple concurrent engineering development efforts
• Experience establishing and enforcing technical and programmatic standards across teams
• Exceptional communication ability with diverse technical and executive audiences

Preferred Skills and Experience

• Professional or academic exposure to chemical engineering, biomedical engineering, or a related process engineering discipline
• Experience building, scaling, or managing hardware engineering teams
• Experience owning technical roadmaps or standardized hardware product offerings
• Experience developing or operating hardware for pharmaceutical, bioprocess, or sterile/cleanroom manufacturing applications
• Familiarity with microgravity fluid behavior, capillary-driven flows, or two-phase fluid management
• Familiarity with cGMP principles or regulated hardware environments
• Significant experience planning and executing environmental testing (vibration, TVAC, EMI/EMC)

Pay Range

• Salary range: $200,000 - $250,000/per year
• This role is on-site in El Segundo, CA
• Leveling and base salary is determined by job-related skills, education level, experience level, and job performance
• You will be eligible for incentives in the form of stock options and/or long-term cash awards

We are looking for a highly motivated Senior Field Application Scientist to join our team! 

This is a full time onsite position at our Fremont, CA location.

How You’ll Contribute

• Empower customers by guiding application development efforts that unlock the full potential of our technology platform
• Deliver expert training to customers on the latest processes, kits, and instrumentation, empowering them for success
• Lead troubleshooting efforts and collaborate with internal experts to ensure fast, effective resolution of customer issues
• Take ownership of customer issues by documenting, resolving, and escalating cases promptly and professionally to ensure customer satisfaction
• Partner with sales to deliver technical and market guidance across the customer journey, including the design and execution of pilot experiments that enable successful technology adoption
• Collaborate cross-functionally with sales and marketing to develop and present engaging, high-impact product demonstrations and technical content
• Represent the company at customer sites and scientific conferences, serving as a technical ambassador for our solutions
• Other duties as assigned

Qualifications, Skills, Knowledge & Abilities

• Degree in Molecular Biology, Biochemistry, Biology, Biotechnology, Biomedical Engineering, or a closely related field, with extensive laboratory experience across multiple life science platforms, particularly in next-generation sequencing (NGS)
• BS with 8+ years of relevant experience, MS with 5+ years, or PhD with 3+ years of related experience
• Hands-on experience and a strong working knowledge of next-generation sequencing (NGS) library preparation workflows, including sample handling, quality control, and optimization across diverse input types
• Experience in the development of biomedical or scientific instruments and in the generation and/or analysis of genomic data
• Demonstrated ability to balance long-term strategic goals with short-term deliverables
• Self-driven and highly motivated, with the ability to operate with urgency, ownership and accountability in a fast-paced, collaborative, multidisciplinary startup environment
• Meticulous attention to detail and the ability to follow complex operating procedures accurately
• Excellent organizational and problem-solving skills, with a commitment to high-quality results
• Strong communication, presentation, and relationship-building skills
• Experience teaching, training, or mentoring peers or customers
• Willingness to travel up to 50% of the time and reside within one to two hours of a major airport. Travel includes field support with sales, customer meetings, and participation in trade shows and conferences

At Ultima Genomics, your base pay is one part of your total compensation package. This role pays between $120,000 and $150,000, if performed in California, and your actual base pay will depend on your skills, qualifications, experience, and location.  Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.  This role is also eligible for a competitive benefits package that includes: medical, dental, vision, life, and disability insurance; 401(k) retirement plan; flexible spending & health savings account; paid holidays; paid time off; employee assistance program; and other company benefits.

#LI-Onsite