About Avalyn

Avalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn’s AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has demonstrated encouraging safety and clinical activity across Phase 1b and an ongoing, multi-year open-label extension trial, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Avalyn’s AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA-IPF, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies. For more information, please visit avalynpharma.com and follow the company on LinkedIn.

Position Overview

The Associate Director of SEC Reporting & Technical Accounting will build and lead Avalyn’s external reporting and SOX compliance capabilities as a newly public biotechnology company. This high-impact, foundational position is ideal for a technically strong, pragmatic leader who enjoys creating structure in a dynamic, mission-driven environment. The Director will establish scalable SEC reporting processes, design and document internal controls over financial reporting, and serve as the Company’s subject matter expert on complex accounting matters. Reporting to the VP of Finance, this role partners closely with Finance and cross-functional teams across the organization to drive alignment, accountability, and best practices through strong collaboration and clear communication.

SEC Reporting

• Lead the preparation and timely filing of SEC reports, including Forms 10-K, 10-Q, 8-K, and S-8, and oversee XBRL tagging and related external reporting processes.
• Own the preparation and review of financial statements, footnotes, and MD&A, ensuring compliance with U.S. GAAP and SEC regulations.
• Partner with Legal, FP&A, Investor Relations, and senior leadership on earnings releases, proxy materials, and other public disclosures.

Technical Accounting

• Serve as the company’s subject matter expert on technical accounting matters, including revenue recognition, collaboration and licensing arrangements, R&D activities, financing transactions, and stock-based compensation under ASC 718.
• Research, evaluate, and document accounting conclusions for complex transactions and prepare technical accounting memoranda and policy documentation.
• Support commercialization readiness by helping establish GAAP- and SOX-compliant revenue accounting and order-to-cash processes in partnership with Commercial, Market Access, Finance, and IT.

SOX Compliance & Internal Controls

• Design and implement internal controls over financial reporting as the company continues to build toward full SOX compliance.
• Lead walkthroughs, risk assessments, control documentation, and remediation efforts in partnership with process owners and external consultants.
• Strengthen scalable controls and operating processes across SEC reporting, technical accounting, and equity administration.

Equity Accounting & Administration

• Lead equity accounting, including the calculation and recording of stock-based compensation in accordance with ASC 718.
• Oversee external support for day-to-day stock administration activities and help ensure strong governance around equity-related processes.
• Support Section 16 reporting and related compliance requirements in coordination with legal counsel.

External Audits

• Manage quarterly reviews and annual audits and serve as the primary liaison with external auditors on technical accounting matters.
• Coordinate PBC requests and support an efficient, well-organized audit process.

Qualifications

• A minimum of a Bachelor’s degree in Accounting or Finance required; CPA required.
• 8-10+ years of progressive accounting experience, including substantial SEC reporting and technical accounting experience in a public company environment.
• Big 4 or national public accounting firm experience strongly preferred.
• Demonstrated experience building or enhancing SOX compliance programs.
• Experience in biotechnology, life sciences, or other R&D-intensive industries strongly preferred; experience with cell therapy revenue recognition is a plus.
• Deep knowledge of U.S. GAAP and SEC regulations, including revenue recognition, equity compensation, and complex transaction accounting.
• Experience with tools such as Active Disclosure, Equity Edge, NetSuite, or similar systems preferred.
• Strong communication, sound judgment, and the ability to lead through influence in a fast-paced, mission-driven environment.

Location: Galena, KS

Position Summary
The Laboratory Technician supports Manufacturing, Quality, Formulation operations by performing routine laboratory testing, material inspections, documentation, and data analysis. This role helps ensure product quality, regulatory compliance, and adherence to established safety and quality system requirements. 

Compensation & Benefits 

• Employee Ownership (ESOP): Company-funded retirement contribution of ~18% of pay, plus 401(k) 
• Competitive pay with bonus opportunity 
• Comprehensive benefits: Medical, Dental, Vision, Life, Disability, FSA, and Pet Insurance 
• Generous paid time off, paid holidays, and parental leave 
• Fitness reimbursement and tuition assistance 

Essential Duties & Responsibilities

• Perform routine physical and analytical testing of raw materials, in-process samples and finished product, including particle size distribution, pH, emulsion stability, specific gravity in accordance with approved SOPs and test methods.
• Collect, Record & Analyze Manufacturing/Lab/Quality data in graphical form.
• Monitor and approve line start-ups and clearances for both liquid and granular production in collaboration with manufacturing.
• Support formulation chemists in closure of Manufacturing batches in D365 & assist in D365 Inventory management.
• Catalog, label, retain, store, and retrieve samples in accordance with retention and storage procedures.
• Support in processing documentation for inbound/outbound loads for raw materials for Manufacturing/Quality Lab Processes.
• Monitor and assist with correcting all observed non-conformances during production.
• Follow all applicable SOPs, work instructions, safety procedures, and quality policies; promptly report nonconformances, deviations, or safety concerns to supervision.
• Maintain good housekeeping practices and comply with environmental, health, and safety (EHS) requirements, including proper use of personal protective equipment (PPE) 
• Perform other related duties assigned in support of laboratory, manufacturing, or quality operations. 

Required Qualifications

• High School Diploma with experience in related laboratory workplace; or Associates or BA/BS in a science degree.
• Basic proficiency in Microsoft Excel (data entry, basic formulas, charts). 
• Working knowledge of Microsoft Outlook, Word, and PowerPoint. 
• Competent basic math skills. 
• Ability to follow written procedures and instructions accurately. 
• Strong attention to detail and organizational skills. 
• Ability to work effectively in a team environment and communicate professionally. 
• Ability to complete assigned tasks with limited supervision when required. 
• Ability to lift to 50 pounds. 
• Ability to stand and walk for extended periods during the work shift. 
• Ability to climb ladders and stairs to perform inspections. label, retain, store, and retrieve samples in accordance with retention and storage procedures. 

Preferred Qualifications

• Previous laboratory, manufacturing, or quality experience preferred but not required. 

Work Environment & Culture 

We offer a collaborative, employee-owned workplace where accountability, teamwork, and continuous improvement matter. Employees are encouraged to share ideas, grow their skills, and build long-term careers. 

Equal Opportunity Employer 

We are an Equal Opportunity Employer and are committed to creating an inclusive workplace for all employees. 

Ready to Apply? 

If you enjoy dependable, hands-on work and want to be part of a team that values safety, teamwork, and ownership, we’d love to hear from you. 
Apply today. 

Your Impact

We are looking for a forward thinking and highly motivated team player to join our Accounting Strategy and Financial Reporting team. You will lead accounting research and operational analysis with a primary focus on M&A, strategic equity and debt investments, new accounting and reporting standards, and other special projects. You will also have an opportunity to support the SEC reporting and earnings release process, including overseeing aspects of financial statement disclosures and involvement with reporting non-GAAP financial measures.

In this role, you will collaborate closely with our Strategy and Corporate Development team and, where applicable, strategically advise them on the accounting implications of unique transactions. Additionally, you will be involved in the development of clear, actionable accounting policies and informative trainings. You will also have an opportunity to present your research results and assessment findings and recommendations to senior leadership and key cross-functional stakeholders.

What You’ll Do

Work Location: This role is eligible to be based out of any of Axon's US hub offices (Atlanta/Peachtree Corners, Boston/Back Bay, NYC/Manhattan, Phoenix/Scottsdale, San Francisco/Presidio, Seattle/Downtown) and follows a hybrid schedule. We rely on in-person collaboration and ask that team members work onsite Tuesdays through Fridays, with the flexibility to work remotely on Mondays, unless there is an approved workplace accommodation. We believe that connection fuels innovation, and our in-office culture is designed to foster meaningful teamwork, mentorship, and shared success.

Reports to: Vice President of Financial Reporting and Strategic Investments

• Participate on cross-functional teams as a representative of the Finance organization in evaluating the accounting for potential M&A and investment areas and ad-hoc specific opportunities being considered by the Company.
• Create and review technical memoranda, accounting policies, training materials, and other documentation supported and corroborated by research, analysis and concise conclusions.
• Articulate issues and recommendations in a crisp and concise manner to both financial and non-financial stakeholders to enable better decision-making.
• Establish, maintain, and provide expertise on current and upcoming U.S. GAAP, including topics specific to M&A, private and public equity, debt instruments, consolidation, VIE and equity-method accounting, and the related presentation and disclosure requirements.
• Lead and/or contribute to relevant projects on behalf of the accounting team, such as acquisitions or other strategic investments and new accounting pronouncements.
• Work closely with other stakeholders to assist in the integration of acquisitions and strategic partnerships.
• Assist in the identification and resolution of key US GAAP and SEC reporting issues and formulation of findings into memos and disclosures.
• Assist in the preparation and tie out of Forms 8-K, 10-Q, and 10-K, external presentations and reports and peer disclosure benchmarking.
• Periodically assist in the review and advise key leaders on significant contract implications.
• Proactively monitor and operate a robust internal control environment in compliance with Sarbanes-Oxley or similar requirements.
• Collaborate with other departments to support company initiatives.

What You Bring

• Bachelor’s Degree in Accounting, Finance, Business, or similar field required.
• At least eight years of experience with a top-tier accounting (Big 4 strongly preferred) or strategy firm. National Office and/or transactional advisory experience preferred.
• CPA designation required.
• Strong technical knowledge of US GAAP (familiarity with ASC sections 805, 810, 815, 820, 606, 321, and 323 preferred) and SEC reporting requirements.
• Ability to research technical accounting matters and prepare well written memorandums and presentations articulating these matters to well versed accountants and non-finance stakeholders both internal and external to the organization.
• Sarbanes-Oxley Act (SOX) experience and the ability to implement business processes required to ensure compliance with its tenets.
• Ability to leverage Artificial Intelligence tools (i.e. ChatGPT) to enhance productivity of yourself and the organization.
• Superb attention to detail, strong planning and organization skills, and the ability to multi-task, prioritize and deliver in a fast-paced, dynamic environment.
• Professional and driven “can-do” attitude.

Benefits that Benefit You

• Competitive salary and 401k with employer match
• Discretionary paid time off
• Paid parental leave for all
• Medical, Dental, Vision plans
• Fitness Programs
• Emotional & Mental Wellness support
• Learning & Development programs
• And yes, we have snacks in our offices

Benefits listed herein may vary depending on the nature of your employment and the location where you work.

Your Impact

We are looking for a forward thinking and highly motivated team player to join our Accounting Strategy and Financial Reporting team. You will lead accounting research and operational analysis with a primary focus on M&A, strategic equity and debt investments, new accounting and reporting standards, and other special projects. You will also have an opportunity to support the SEC reporting and earnings release process, including overseeing aspects of financial statement disclosures and involvement with reporting non-GAAP financial measures.

In this role, you will collaborate closely with our Strategy and Corporate Development team and, where applicable, strategically advise them on the accounting implications of unique transactions. Additionally, you will be involved in the development of clear, actionable accounting policies and informative trainings. You will also have an opportunity to present your research results and assessment findings and recommendations to senior leadership and key cross-functional stakeholders.

What You’ll Do

Work Location: This role is eligible to be based out of any of Axon's US hub offices (Atlanta/Peachtree Corners, Boston/Back Bay, NYC/Manhattan, Phoenix/Scottsdale, San Francisco/Presidio, Seattle/Downtown) and follows a hybrid schedule. We rely on in-person collaboration and ask that team members work onsite Tuesdays through Fridays, with the flexibility to work remotely on Mondays, unless there is an approved workplace accommodation. We believe that connection fuels innovation, and our in-office culture is designed to foster meaningful teamwork, mentorship, and shared success.

Reports to: Vice President of Financial Reporting and Strategic Investments

• Participate on cross-functional teams as a representative of the Finance organization in evaluating the accounting for potential M&A and investment areas and ad-hoc specific opportunities being considered by the Company.
• Create and review technical memoranda, accounting policies, training materials, and other documentation supported and corroborated by research, analysis and concise conclusions.
• Articulate issues and recommendations in a crisp and concise manner to both financial and non-financial stakeholders to enable better decision-making.
• Establish, maintain, and provide expertise on current and upcoming U.S. GAAP, including topics specific to M&A, private and public equity, debt instruments, consolidation, VIE and equity-method accounting, and the related presentation and disclosure requirements.
• Lead and/or contribute to relevant projects on behalf of the accounting team, such as acquisitions or other strategic investments and new accounting pronouncements.
• Work closely with other stakeholders to assist in the integration of acquisitions and strategic partnerships.
• Assist in the identification and resolution of key US GAAP and SEC reporting issues and formulation of findings into memos and disclosures.
• Assist in the preparation and tie out of Forms 8-K, 10-Q, and 10-K, external presentations and reports and peer disclosure benchmarking.
• Periodically assist in the review and advise key leaders on significant contract implications.
• Proactively monitor and operate a robust internal control environment in compliance with Sarbanes-Oxley or similar requirements.
• Collaborate with other departments to support company initiatives.

What You Bring

• Bachelor’s Degree in Accounting, Finance, Business, or similar field required.
• At least eight years of experience with a top-tier accounting (Big 4 strongly preferred) or strategy firm. National Office and/or transactional advisory experience preferred.
• CPA designation required.
• Strong technical knowledge of US GAAP (familiarity with ASC sections 805, 810, 815, 820, 606, 321, and 323 preferred) and SEC reporting requirements.
• Ability to research technical accounting matters and prepare well written memorandums and presentations articulating these matters to well versed accountants and non-finance stakeholders both internal and external to the organization.
• Sarbanes-Oxley Act (SOX) experience and the ability to implement business processes required to ensure compliance with its tenets.
• Ability to leverage Artificial Intelligence tools (i.e. ChatGPT) to enhance productivity of yourself and the organization.
• Superb attention to detail, strong planning and organization skills, and the ability to multi-task, prioritize and deliver in a fast-paced, dynamic environment.
• Professional and driven “can-do” attitude.

Benefits that Benefit You

• Competitive salary and 401k with employer match
• Discretionary paid time off
• Paid parental leave for all
• Medical, Dental, Vision plans
• Fitness Programs
• Emotional & Mental Wellness support
• Learning & Development programs
• And yes, we have snacks in our offices

Benefits listed herein may vary depending on the nature of your employment and the location where you work.

Your Impact

We are looking for a forward thinking and highly motivated team player to join our Accounting Strategy and Financial Reporting team. You will lead accounting research and operational analysis with a primary focus on M&A, strategic equity and debt investments, new accounting and reporting standards, and other special projects. You will also have an opportunity to support the SEC reporting and earnings release process, including overseeing aspects of financial statement disclosures and involvement with reporting non-GAAP financial measures.

In this role, you will collaborate closely with our Strategy and Corporate Development team and, where applicable, strategically advise them on the accounting implications of unique transactions. Additionally, you will be involved in the development of clear, actionable accounting policies and informative trainings. You will also have an opportunity to present your research results and assessment findings and recommendations to senior leadership and key cross-functional stakeholders.

What You’ll Do

Work Location: This role is eligible to be based out of any of Axon's US hub offices (Atlanta/Peachtree Corners, Boston/Back Bay, NYC/Manhattan, Phoenix/Scottsdale, San Francisco/Presidio, Seattle/Downtown) and follows a hybrid schedule. We rely on in-person collaboration and ask that team members work onsite Tuesdays through Fridays, with the flexibility to work remotely on Mondays, unless there is an approved workplace accommodation. We believe that connection fuels innovation, and our in-office culture is designed to foster meaningful teamwork, mentorship, and shared success.

Reports to: Vice President of Financial Reporting and Strategic Investments

• Participate on cross-functional teams as a representative of the Finance organization in evaluating the accounting for potential M&A and investment areas and ad-hoc specific opportunities being considered by the Company.
• Create and review technical memoranda, accounting policies, training materials, and other documentation supported and corroborated by research, analysis and concise conclusions.
• Articulate issues and recommendations in a crisp and concise manner to both financial and non-financial stakeholders to enable better decision-making.
• Establish, maintain, and provide expertise on current and upcoming U.S. GAAP, including topics specific to M&A, private and public equity, debt instruments, consolidation, VIE and equity-method accounting, and the related presentation and disclosure requirements.
• Lead and/or contribute to relevant projects on behalf of the accounting team, such as acquisitions or other strategic investments and new accounting pronouncements.
• Work closely with other stakeholders to assist in the integration of acquisitions and strategic partnerships.
• Assist in the identification and resolution of key US GAAP and SEC reporting issues and formulation of findings into memos and disclosures.
• Assist in the preparation and tie out of Forms 8-K, 10-Q, and 10-K, external presentations and reports and peer disclosure benchmarking.
• Periodically assist in the review and advise key leaders on significant contract implications.
• Proactively monitor and operate a robust internal control environment in compliance with Sarbanes-Oxley or similar requirements.
• Collaborate with other departments to support company initiatives.

What You Bring

• Bachelor’s Degree in Accounting, Finance, Business, or similar field required.
• At least eight years of experience with a top-tier accounting (Big 4 strongly preferred) or strategy firm. National Office and/or transactional advisory experience preferred.
• CPA designation required.
• Strong technical knowledge of US GAAP (familiarity with ASC sections 805, 810, 815, 820, 606, 321, and 323 preferred) and SEC reporting requirements.
• Ability to research technical accounting matters and prepare well written memorandums and presentations articulating these matters to well versed accountants and non-finance stakeholders both internal and external to the organization.
• Sarbanes-Oxley Act (SOX) experience and the ability to implement business processes required to ensure compliance with its tenets.
• Ability to leverage Artificial Intelligence tools (i.e. ChatGPT) to enhance productivity of yourself and the organization.
• Superb attention to detail, strong planning and organization skills, and the ability to multi-task, prioritize and deliver in a fast-paced, dynamic environment.
• Professional and driven “can-do” attitude.

Benefits that Benefit You

• Competitive salary and 401k with employer match
• Discretionary paid time off
• Paid parental leave for all
• Medical, Dental, Vision plans
• Fitness Programs
• Emotional & Mental Wellness support
• Learning & Development programs
• And yes, we have snacks in our offices

Benefits listed herein may vary depending on the nature of your employment and the location where you work.

The Role 

This role is remote, with 50% travel to the states we have cultivation/production facilities, primarily travel will be in mid-west and east coast but could be in any of the 14 states we operate. 

GTI just keeps growing and growing! We’re seeking a logistical genius and construction management guru to oversee CPG construction projects.  As a Construction Project Manager for GTI CPG, you will be responsible for serving as the liaison between GTI HQ and our Cultivation/Processing Facility build-outs in the field ensuring scope of work is executed, quality of brand is maintained, timelines are beat, and budgets are always in the green! You should have off the charts communication skills to work with sub-contractors/vendors and your teammates alike. As a proven Construction PM, you have managed 20+ projects at a time working across a national landscape. 

Responsibilities 

Manufacturing Facility Construction (Primary Focus)

• Lead full lifecycle construction of manufacturing facilities from site feasibility through commissioning and turnover
• Oversee build-outs for:
• Commercial production kitchens
• Infusion and formulation labs
• Packaging and labeling lines
• Automated filling and bottling systems
• Vaults and finished goods storage
• Cold storage and environmental-controlled rooms
• Coordinate sanitary design standards and cGMP-aligned construction
• Ensure compliance with:
• Local health department regulations
• OSHA requirements
• State cannabis manufacturing regulations
• Food-grade and pharmaceutical-grade standards where applicable
• Manage integration of:
• Process utilities (compressed air, steam, chilled water)
• High-capacity electrical infrastructure
• HVAC systems for temperature and humidity control
• Cleanable wall/ceiling systems and floor coatings
• Oversee equipment procurement, vendor coordination, installation, and startup sequencing
• Lead commissioning and operational readiness efforts with site manufacturing teams

Extraction Facilities (Secondary Focus)

• Support construction of:
  • Hydrocarbon, ethanol, CO₂, and solventless extraction rooms
  •  Post-processing and refinement labs
  • Solvent storage and recovery systems
• · Coordinate C1D1 / C1D2 rated spaces and hazardous electrical systems
• · Ensure compliance with NFPA, fire code, and AHJ requirements
• · Manage specialized HVAC and gas detection systems

Cultivation Facilities (Secondary Focus)

• Support build-outs of:
  • Flower, veg, and propagation rooms
  • Drying and curing spaces
  • Irrigation and fertigation systems
  • Environmental control (HVACD) systems
• · Coordinate high-load mechanical systems and infrastructure upgrades

Core Project Management Responsibilities

• Direct all phases of construction management:
  • Feasibility and due diligence
  • Budget development and cost control
  • Scheduling and resource planning
  • Design coordination
  • Field execution
  • Commissioning and close-out
• Develop resource-loaded critical path schedules
• Prepare and manage capital budgets and cashflow projections
• Act as single point of contact between HQ, site leadership, engineering, vendors, contractors, landlords, and governing authorities
• Track project performance across cost, schedule, scope, and quality metrics
• Identify and mitigate operational and regulatory risk
• Maintain strict adherence to corporate quality, safety, and brand standards

Qualifications 

• Bachelor’s degree in engineering, Construction Management, Architecture, or related field, preferred
• 5+ years of project management experience, preferred

• Preferred experience with: 

• Controlled Environmental Agriculture (CEA) 

• Greenhouse or indoor grow facilities 

• High-capacity HVAC and mechanical systems 

• Industrial electrical distribution systems 

• Experience managing multi-site, multi-state expansion programs 

• Strong understanding of environmental controls and agricultural infrastructure preferred 

Technical Skills 

• Proficient in construction management software such as: 

• Primavera P6 

• Procore 

• Timberline 

• PlanGrid (or similar) 

• Advanced Microsoft Project and Excel (budget tracking, forecasting, modeling) 

• Ability to interpret mechanical, electrical, irrigation, and environmental control drawings 

• Experience coordinating large mechanical subcontractors and specialty vendors 

Professional Attributes 

• Highly analytical and systems-oriented 

• Strong critical thinking and problem-solving capabilities 

• Comfortable managing 15–20+ concurrent projects nationally 

• Effective communicator across operations, engineering, compliance, and executive leadership 

• Operates with professionalism and integrity 

• Thrives in fast-paced, high-growth environments 

Additional Requirements 

• Must pass all required background checks 

• Must remain compliant with all applicable state and company regulations 

• Flexible schedule required, including occasional evenings/weekends during critical project phases 
• Willingness to travel nationally as required 

What we're looking for:

What we're looking for:

What we're looking for:

ABOUT THE ROLE

The Sr. Scientist LNP Formulation & Process Development will contribute to the development and optimization of nChroma’s Lipid Nanoparticle (LNP) formulations and collaborate with both internal research teams and external CROs/CDMOs to support multiple programs spanning early research and development. 

RESPONSIBILITIES

• Leverage both internal team and external CROs to optimize and produce high quality LNPs to support efforts spanning early research and development.
• Provide SME support for external production with our CDMO partners.
• Lead from the bench and contribute to a high-performing Formulation & PD team, including initiating excellent laboratory and documentation practices, and providing mentorship and development opportunities for junior team members.
• Contribute as CMC representative for GMP production support & regulatory filings as needed. Collaborate with key stakeholders from research, drug substance, analytical development, pharmacology and other internal functions to support program, department, and corporate goals.

SKILLS & COMPETENCIES:

• Hands on experience with LNP formulation including optimization, conjugation, scale-up.
• Direct managerial experience.
• Excellent analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective.
• Strong oral and written communication skills with experience presenting scientific research.
• Ability to thrive in a fast-paced, innovative, and, at times, uncertain or changing environment while remaining flexible, proactive, and resourceful.
• Adept at prioritizing and managing multiple tasks simultaneously, integrating cross-functional issues, and balancing competing priorities effectively.
• Collaborative and team-oriented mindset with a desire to positively impact culture.

QUALIFICATIONS:

• 4-5 years in the biopharmaceutical industry with a proven track record with nucleic acids delivery, LNP formulation and scale up, including tech transfer to GMP suites.
• Advanced degree in Chemistry, Biophysics, Biochemistry, Bioengineering, or related life sciences with strong scientific background.
• Preferred in-depth experience with analytical assays for LNP characterization.
• Experience providing guidance and mentorship to junior scientists.
• Experience supporting development programs, including communicating between CMC and Program Teams.

The salary range for this role is $145K - $175K

About the Position 

The Associate Director, Drug Product, will provide strategic and hands-on operational leadership for all CMC activities related to drug product development and manufacturing, with a primary focus on sterile injectables (lyophilized and liquid) at all stages of development (IND-enabling to commercialization).

The Associate Director, Drug Product, will be responsible for overseeing the formulation development, fill-finish, packaging, and release of drug products at CDMOs ensuring manufacturing operations align with program timelines, quality standards, and regulatory requirements. This position requires deep expertise in biologics drug product manufacturing, strong technical problem-solving abilities, and proven experience managing complex manufacturing operations with external partners. You will play a critical role in accelerating our mission of bringing new treatments to patients faster and more efficiently.

Responsibilities

Development and Manufacturing Strategy, Operations and Oversight

• Lead drug product manufacturing strategy and execution for programs from preclinical through commercial stages, ensuring alignment with program objectives, timelines, and budget constraints.
• Serve as the primary technical interface with CDMOs and contract manufacturing organizations for drug product manufacturing activities. Establish and maintain strong partnerships, lead technical discussions, and ensure manufacturing excellence across external manufacturing networks.
• Oversee formulation, aseptic fill-finish, lyophilization (if applicable), visual inspection, labeling, and packaging operations for drug products. Ensure manufacturing processes are robust, scalable, and compliant with cGMP requirements.
• Provide technical guidance and oversight for manufacturing campaigns including batch record review and approval, deviation investigations, change control assessments, and resolution of manufacturing issues
• Support scale-up activities from clinical to commercial manufacturing, including process optimization and validation. Identify and implement continuous improvement opportunities.
• Develop comprehensive manufacturing plans and schedules in collaboration with Project Management, Clinical Supply, and Commercial teams. Track manufacturing timelines and proactively manage risks to ensure on-time delivery of drug product for clinical trials and commercial supply.
• Lead technical assessments and qualification of new CDMOs for drug product manufacturing. Conduct site audits and ongoing performance monitoring. Manage relationships with multiple manufacturing partners across different geographic regions

Additional Core CMC Responsibilities (Quality, Regulatory & Cross-Functional)

• Ensure all manufacturing activities comply with cGMP regulations, ICH guidelines, and internal quality standards. Support regulatory inspections and audits at manufacturing sites. Review and approve batch records, protocols, and manufacturing-related documentation.
• Author and review CMC sections of regulatory submissions (INDs, BLAs, CTAs) related to drug product manufacturing, process validation, and manufacturing site changes. Support responses to health authority questions.
• Partner closely with Drug Substance Manufacturing, Analytical Development, Quality Assurance, Regulatory Affairs, Clinical Supply, and Project Management leads to ensure seamless integration of manufacturing activities into overall program execution.
• Collaborate with procurement to ensure timely contracting for drug product manufacturing.

About You 

• MS or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Biotechnology, or related discipline.
• 6+ years of experience in the biopharmaceutical industry with hands-on experience in biologics drug product manufacturing, formulation development, and fill-finish operations.
• Demonstrated track record of successfully managing drug product manufacturing campaigns for biologics (proteins, monoclonal antibodies, antibody-drug conjugates, or other large molecules) from preclinical through late-stage clinical or commercial manufacturing.
• Technical expertise in aseptic fill-finish operations, lyophilization processes, formulation development, stability programs, and drug product characterization for biologics.
• Extensive experience working with CDMOs and contract manufacturing organizations, including site selection, technology transfers, manufacturing oversight, and performance management. Proven ability to troubleshoot complex manufacturing issues and drive continuous improvement initiatives.
• Strong knowledge of cGMP regulations, FDA and EMA guidelines, ICH quality guidelines, and regulatory expectations for drug product manufacturing.
• Experience authoring and reviewing CMC sections of regulatory submissions (INDs, BLAs, CTAs) related to drug product manufacturing and validation activities.
• Strong project management skills with demonstrated ability to manage multiple manufacturing programs simultaneously, meet aggressive timelines, and navigate competing priorities.
• Excellent communication and interpersonal skills with ability to influence and build strong relationships with internal stakeholders and external manufacturing partners.
• Willingness to travel domestically and internationally (approximately 20-30%) to manufacturing sites for audits, manufacturing oversight, and technical meetings.

Total Compensation Range: $177,000 - $235,000

POSITION OVERVIEW:
We are seeking a Sr. Fill–Finish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support the capital project buildout of a new fill–finish suite within a commercial manufacturing facility. The ideal candidate has hands-on expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection processes, and associated equipment technologies, along with a strong understanding of GMP operations and regulatory expectations. This position partners closely with operations, QA, validation, MS\&T, engineering, and supply chain to ensure robust, compliant, and continuously improving manufacturing performance.

WORK LOCATION:
Travel to client sites may be required up to 100% based on project phase and client needs.

KEY RESPONSIBILITIES:
(This list is not exhaustive and may be adjusted as needed.)

• Support design, construction, installation, and qualification of a new commercial fill–finish suite, including cleanrooms, process utilities, and supporting infrastructure.
• Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews.
• Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, depyrogenation tunnels, autoclaves, CIP/SIP systems, formulation vessels, sterile filtration skids, and inspection machines.
• Conduct field walkdowns, verify installation details, and ensure alignment with drawings, P\&IDs, and GMP requirements.
• Serve as subject matter expert for fill–finish operations including formulation, filtration, filling, lyophilization, capping, and visual inspection.
• Partner with Operations and MS\&T to troubleshoot and resolve technical issues.
• Collaborate with Maintenance and Reliability teams to address equipment performance gaps.
• Support continuous improvement and process optimization initiatives.
• Partner with QA, Validation, and MS\&T to maintain validated state of aseptic manufacturing processes.
• Ensure alignment with regulatory requirements including FDA, EMA, ICH, and Annex 1.
• Support continued process verification (CPV), annual product review (APR/PQR), and ongoing process monitoring.
• Author, review, and approve GMP documentation, including batch records, SOPs, change controls, CAPAs, deviations, and technical reports.
• Generate and maintain engineering lifecycle documentation including impact assessments, URS/FRS documents, FAT/SAT packages, and turnover packages.
• Develop and execute commissioning and qualification protocols.
• Utilize systems such as building management systems, process control systems, and computerized maintenance management systems. Experience with digital validation platforms such as KNEAT is a plus.
• Ensure all work complies with GMP standards, safety expectations, and regulatory guidelines
• Coordinate across engineering, operations, facilities, quality, and validation to ensure successful project execution.
• Participate in project planning, scheduling, risk assessments, and milestone tracking.
• Provide effective communication to stakeholders at all levels.

QUALIFICATIONS AND REQUIREMENTS:

Education

• Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or a related technical field.

Experience

• Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing.
• Strong preference for sterile, aseptic, biologics, or vaccine fill–finish experience.
• Experience supporting commercial manufacturing operations in a regulated environment.
• Experience with commissioning, qualification, and engineering documentation.

Knowledge, Skills, and Abilities

• Strong understanding of aseptic operations, cleanroom environments, and fill–finish equipment.
• Strong documentation and technical writing skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong communication, analytical, and problem-solving skills.
• Ability to work independently and collaboratively.

ESSENTIAL FUNCTIONS:

Physical Demands: 

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. 

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. 

LEGAL STATEMENT:
 
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer. 

September 24, 2025

Position:   
Senior Computational Biologist/ ML Scientist 

Company Overview:   
At Kernal Bio, we engineer human cells inside the body using selective mRNA-LNP technology to treat cancer and autoimmune diseases. Our AI-designed mRNAs, delivered via antibody-decorated lipid nanoparticles (LNPs), ensure precise targeting and minimize off-target effects. Our KR-402 program focuses on hematological malignancies and autoimmune disorders, achieving >90% in vivo delivery efficiency with T-cell-targeted LNPs. The KR-335 program, targeting solid tumors resistant to standard immunotherapies, shows a 100x therapeutic index with strong efficacy and tolerability in preclinical models, including mice and non-human primates.

With roots at MIT, Harvard, Merck, and BMS, our management team has spearheaded the development of three FDA-approved therapies and holds over 120 patents. Based in Cambridge, MA, and backed by Hummingbird Ventures, Amgen Ventures, NVIDIA, and NASA, Kernal Bio is revolutionizing mRNA therapeutics by leveraging AI to deliver precision treatments within the body. 

Job Summary 

Senior Computational Biologist/ ML Scientist 
We are seeking a Senior Computational Biologist to join our dynamic R&D team and spearhead our drug discovery efforts. This is a chance to move beyond routine data analysis and creatively apply advanced computational methods to solve complex biological challenges. You will be a key driver in designing next generation mRNA therapeutics, directly impacting our pipeline and scientific strategy.

The Role
As a core member of our research group, you will leverage your expertise to extract meaningful insights from diverse datasets. Your primary focus will be on applying sophisticated data science and machine learning techniques to biological questions. You’ll collaborate closely with diverse cross-functional teams, including our wet lab scientists, synthetic biology, and formulation teams, acting as a bridge between data and discovery.

Key responsibilities include:

Data Analysis & Modeling: Design and execute rigorous statistical and computational analyses by integrating and analyzing diverse omics datasets, including genomics, transcriptomics, proteomics, and single-cell sequencing data. You will also be responsible for developing, training, and deploying novel AI/machine learning models to predict biological outcomes and accelerate drug discovery.

High-Performance Computing: Efficiently manage and scale computational workloads by leveraging cloud computing platforms and utilizing NVIDIA GPU-accelerated computing for data processing and model training.

Scientific Communication: Prepare scientific manuscripts, contribute to intellectual property filings, and present your findings at leading scientific conferences and internal meetings.

Documentation & Workflow: Meticulously document all computational workflows, experimental results, and analyses in an Electronic Lab Notebook (ELN) such as Benchling and maintain rigorous version control and facilitate collaborative code development using platforms like GitHub.

Mentorship: Guide and mentor junior team members, sharing your knowledge of best practices in computational analysis and scientific inquiry.

Who We’re Looking For
We are looking for a creative and detail-oriented scientist with a proven track record. You should have a Ph.D. in Computational Biology, Bioinformatics, or a related field, along with a minimum of 3 years of experience in the biopharmaceutical industry.

You are a master of your craft with:

Deep Expertise: A strong background in the analysis of high-throughput biological data, including genomics, transcriptomics, proteomics, and single-cell sequencing.

Modern Skill Set: Experience applying machine learning and AI, with a solid theoretical grasp of algorithms like gradient descent, Bayesian optimization, and other heuristic search methods. Proficiency with large language models (LLMs) is a significant plus.

Accelerated Computing: Hands-on experience with NVIDIA GPU-accelerated computing is highly valued. Familiarity with CUDA, cuDNN, or NVIDIA Clara for bioinformatics applications will set you apart.

Programming Prowess: Exceptional fluency in Python and experience with workflow management systems, with a strong emphasis on version control using Git/GitHub.

Cloud Computing: Hands-on experience with at least one major cloud platform (AWS, Azure, or Google Cloud).

Intellectual Curiosity: A creative, out-of-the-box thinker who is eager to learn new methods and tackle complex problems head-on.

Collaborative Spirit: Excellent communication and time-management skills, with the ability to manage multiple projects and work effectively within cross-functional teams.

Benefits:

• Competitive 401(k)   
• Highly competitive healthcare coverage (PPO/HMO)
• Free parking, a monthly subway pass, or a subsidized commuter rail pass  
• Free Bluebike Membership
• Gym Membership Support   
• Flexible Spending Account 
• Paid parental leave, family caregiver leave, and medical leave  
• Paid life insurance coverage 
• On-site cafeteria  
• Competitive vacation and sick days per year 

Kernal provides a diverse work environment and is committed to equal employment opportunities for all its employees and qualified applicants. We do not discriminate in employment practices for the race, color, national origin, age, gender, sexual orientation, marital or veteran status, religion, disability, or any other legally protected status. Kernal Bio will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary Glyph™ technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders. For more information, please visit www.seaporttx.com.

Seaport Therapeutics is seeking someone to lead analytical research and development for its portfolio of small molecule programs targeting neuropsychiatric disorders.  The Senior Director, Analytical R&D, reports to the Vice President, CMC and is responsible for providing strategic and technical leadership for analytical development of small molecules within Seaport’s portfolio, from pre-clinical development to late-stage clinical development. This includes oversight of analytical method development, validation, method transfer to CMO’s, and support of regulatory filings, including investigational new drugs (INDs)/investigational medicinal product dossier (IMPDs) and new drug applications (NDAs). The role also includes strategic partnering with Quality, Development & Manufacturing, and Regulatory to deliver uninterrupted clinical supplies to enable Seaport’s current and future clinical studies.

The role will be accountable for delivering analytical methods that are phase-appropriate and adhere to the highest scientific standards. The successful candidate must be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Research and industry experience should demonstrate successful application and management of state-of-the-art analytical techniques to solve problems, in addition to several years’ experience overseeing analytical development at CMO’s.

The position is responsible for ensuring that all method development, validation and testing (release, stability, and other) performed on behalf of Seaport is conducted in accordance with the appropriate compendial standards, when available, and is compliant to all regulations and industry phase-appropriate testing standards and standard operating procedures.  The Senior Director will also ensure that all testing and testing services coordinate with all other product development activities so that testing does not fall on the critical path and causes product development delays.

The ideal candidate will embrace a collaborative, innovative culture that embodies our values of service to patients impacted by mental health conditions, with a 'we own it' mentality, demonstrating entrepreneurial spirit and technical excellence while fostering teamwork and continuous improvement.

Key Responsibilities:

• Serve as the functional head of Analytical Research & Development, accountable for analytical strategy across Seaport’s small‑molecule portfolio from preclinical through late‑stage clinical development.
• Define and implement phase‑appropriate analytical development strategies for drug substance (DS) and drug product (DP), aligned with overall CMC and regulatory objectives.
• Lead and develop the Analytical function within CMC, including direct management of analytical staff and thoughtful planning for future capability needs as the portfolio advances.

• Establish best practices for analytical lifecycle management, data integrity, documentation, and knowledge transfer.
• Define and execute Seaport’s outsourced analytical strategy, including selection, onboarding, governance, and performance management of CDMOs and contract testing laboratories.
• Provide strategic oversight and day‑to‑day governance of CDMO’s, ensuring adherence to scope, timelines, quality standards, and data integrity expectations.
• Provide technical leadership for analytical method development, validation, and transfer for DS and DP, utilizing techniques including (but not limited to) HPLC-CAD, HPLC-UV, GC, LC-MS, LC‑MS/MS, HPLC-FLR, LC-qToF, GC (Residual Solvents), Elemental impurity analysis, IR, qNMR, thermal analysis, droplet size, PSD, lipolysis, and dissolution/ drug release.
• Ensure analytical methods and specifications are scientifically justified, phase‑appropriate, and compliant with applicable compendial standards and regulatory guidelines.
• Review and approve analytical methods, validation protocols, analytical reports, stability protocols, and stability test reports.
• Oversee stability programs, including trending and proactive identification of potential quality or stability issues.
• Collaborate closely with QA, Regulatory Affairs, Development & Manufacturing, Clinical Supply, and Research to ensure alignment across development activities.
• Ensure analytical activities are integrated into overall project plans and do not become a critical path for development timelines.
• Provide analytical CMC leadership for regulatory filings, including INDs, IMPDs, NDAs, and MAAs, with direct responsibility for authoring and reviewing analytical sections.
• Partner with Quality Assurance to support audits of external testing facilities and contribute to Quality and Service Agreements.

Professional Experience/Qualifications:

• MS or Ph.D. in Analytical Chemistry, Physical Chemistry, or a related scientific discipline.
• 12–15+ years of progressive industry experience in small‑molecule analytical development within pharmaceutical or biotechnology organizations.
• Demonstrated experience leading analytical development across multiple development stages, including late‑stage clinical development and registration‑enabling activities.
• Proven experience serving as a functional or sub‑functional leader, including people leadership and accountability for analytical strategy execution.
• Extensive hands‑on expertise in chromatographic and spectroscopic techniques, including GC, LC, IC, chiral separations, and detection methods such as UV/Vis, CAD, MS (SIM/MRM), fluorescence, FID, and ECD.
• Experience managing analytical development and testing activities through CDMOs and contract laboratories in a virtual or highly outsourced operating model.
• Strong knowledge of global regulatory requirements and ICH guidelines applicable to analytical development and control strategies.
• Experience with complex lipophilic drug substances and formulations, including enabling formulation approaches (e.g., SEDDS, soft‑gel dosage forms).
• Demonstrated ability to lead and influence cross‑functional teams in a fast‑paced, resource‑constrained biotech environment.
• Excellent communication, collaboration, and scientific judgment skills, with the ability to make sound decisions balancing speed, quality, and regulatory expectations.
• Willingness to travel internationally approximately 25% of the time.

At Seaport, we believe transparency and fairness are key to building a culture of trust, respect, and collaboration. We care deeply about the happiness of our team and strive to ensure our total rewards (monetary and non-monetary) program reflects the value each person brings. The expected salary range for this role is $230,000–$270,000, with the final offer based on experience, market data, and internal equity. We encourage open conversations with our talent acquisition team about compensation early in the process to ensure alignment from the start.

About Kernal Biologics, Inc. 

Kernal Bio is a venture-backed therapeutics company engineering cells inside the body using AI-designed, selective mRNA and targeted LNP technology. By developing in vivo CAR-T therapies, Kernal Bio is advancing precision treatments for autoimmune diseases and blood cancers. The company was founded by experts from MIT, Harvard, Merck, and BMS, and its leadership team brings a track record of three FDA-approved therapies and over 120 patents. With support from leading investors, including Hummingbird Ventures, Amgen Ventures, Y Combinator, and HBM. Kernal Bio is transforming the future of cell therapy design and delivery.

Job Summary:

Kernal Bio is seeking a highly motivated and experienced Vice President of Chemistry Manufacturing and Controls (VP of CMC) with expertise in mRNA-tLNP manufacturing to contribute to the development of its mRNA 2.0 platform for therapeutic applications. The successful candidate will inspire and lead a team responsible for manufacturing, process development, and analytical development of mRNA-LNP therapeutics. Proficiency in mRNA-tLNP chemistry and biology workflows, coupled with experience in Good Manufacturing Practices (GMP) mRNA-tLNP manufacturing, is essential for this role.

Responsibilities:

• Lead and scale the CMC organization, defining strategy for mRNA drug substance and targeted LNP (tLNP) drug product from preclinical through clinical development

• Oversee development and scale-up of mRNA IVT manufacturing, purification processes, and tLNP formulation, ensuring robust, reproducible performance

• Build and drive internal manufacturing capabilities, while strategically leveraging and managing CDMOs/CROsfor scale and flexibility

• Drive process development (DOE-driven), optimization, and tech transfer to support GMP manufacturing campaigns (internal and external)

• Establish and manage analytical and bioanalytical strategies (e.g., HPLC, qPCR, ELISA, cell-based assays) to support product characterization, potency, and release

• Define and execute CMC regulatory strategy, including authoring IND/CTA sections and supporting agency interactions

• Partner cross-functionally with R&D and preclinical teams, including coordination of in vivo studies, to ensure alignment between CMC and biology

• Drive innovation and continuous improvement, including evaluation of new technologies and COGS reduction strategies for in vivo CAR-T programs

• Support IP strategy, technical reports, and publications, and present data internally and at external scientific forums

• Build, mentor, and expand a high-performing team, fostering strong execution, data rigor, and clear communication

Requirements:

• PhD/MS/BS in Chemical Engineering, Biomedical Engineering, Chemistry, Biology, Molecular Biology, or related field

• 10–15+ years of industry experience in CMC development, including leadership experience

• 5+ years of experience in nucleic acid and/or lipid nanoparticle (LNP) manufacturing

• Demonstrated experience advancing programs from preclinical to IND/clinical stages

• Deep expertise in mRNA manufacturing (IVT, purification, scale-up, characterization)

• Strong experience with LNP formulation, preferably targeted LNP (tLNP) or conjugation strategies

• Experience in process development, scale-up, and GMP manufacturing

• Strong understanding of CQAs, CPPs, and analytical strategies for nucleic acid therapeutics

• Familiarity with stability, formulation, and product lifecycle management

• Experience authoring CMC sections for IND/CTA filings and supporting regulatory interactions

• Experience selecting and managing CDMOs/CROs, including tech transfer and manufacturing oversight

• Exposure to building or supporting internal manufacturing capabilities

• Experience with analytical techniques (HPLC/UPLC, FPLC, qPCR, ELISA, LC-MS/MS, MALDI-TOF MS, NMR, cell-based assays, flow cytometry)

• Familiarity with nucleic acid chemistry, purification, enzyme kinetics, and biomolecule characterization

• Experience applying Design of Experiments (DoE) and bioprocess engineering principles

• Working knowledge of GMP regulations and quality systems

• Strong ability to analyze, interpret, and communicate scientific data clearly

• Excellent written and verbal communication skills

• Strong organization, record-keeping, and data management skills

• High attention to detail with strong problem-solving and troubleshooting ability

• Proven ability to build, lead, and mentor teams in a fast-paced environment

• Experience working in a startup or high-growth environments

• Ability to work independently while collaborating effectively across teams

Preferred Qualifications

• Experience with targeted lipid nanoparticles (tLNPs) or ligand/antibody conjugation

• Experience with in vivo studies (e.g., rodent models)

• Prior mammalian cell culture experience

• Experience with automation and high-throughput systems

• Track record of innovation, IP filings, or publications

Benefits:

• Competitive 401(k)   
• Highly competitive healthcare coverage (PPO/HMO)
• Free parking, a monthly subway pass, or a subsidized commuter rail pass  
• Free Bluebike Membership
• Gym Membership Support   
• Flexible Spending Account 
• Paid parental leave, family caregiver leave, and medical leave  
• Paid life insurance coverage 
• On-site cafeteria  
• Competitive vacation and sick days per year 

Kernal provides a diverse work environment and is committed to equal employment opportunities for all its employees and qualified applicants. We do not discriminate in employment practices for the race, color, national origin, age, gender, sexual orientation, marital or veteran status, religion, disability, or any other legally protected status. Kernal Bio will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

Company Summary

Avalyn is reimagining the future of pulmonary fibrosis treatment with a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, and reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn’s inhaled approach tackles the underlying pathophysiology of pulmonary fibrosis at its source and is designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s AP01 is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b study in progressive pulmonary fibrosis (PPF). AP01 has been assessed in over 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety compared to historical data with existing therapies. The company completed two Phase 1 studies for AP02, inhaled nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF) and is planning a Phase 2 clinical trial. For more information, please visit avalynpharma.com and follow us on LinkedIn.

Position Summary

The Director of Clinical Operations is a senior-level position responsible for overseeing and managing the clinical operations of assigned clinical trials or program of trials. This role plays a critical role in ensuring the successful planning, execution, and monitoring of Avalyn’s global clinical trials and studies. This position will report to the VP of Clinical Operations and can be remote-based anywhere in the United States.

Key Responsibilities (at the study or program level):

• Strategic Leadership: Develop and implement the operations plans and logistics for their assigned study or program of studies aligning with the organization's goals and objectives. Provide leadership and guidance to the clinical operations team, ensuring the successful execution of clinical programs.
• Clinical Trial Management: Oversee the planning, initiation, execution, and completion of clinical trials in accordance with applicable regulations, guidelines, and standard operating procedures (SOPs). Coordinate with cross-functional teams, including outside vendors, medical affairs, regulatory affairs, data management, and biostatistics, to ensure seamless trial execution.
• Resource Management: Indirectly manage external providers’ study or program level resources to support clinical operations. Directly manage internal resources who support the Director’s assigned studies or program level of studies.  Monitor resource utilization and implement strategies to optimize efficiency and productivity.
• Quality Assurance: Ensure compliance with relevant regulatory requirements, Good Clinical Practice (GCP) guidelines, and internal Standard Operating Procedures (SOPs), and other related quality standards. Work directly with the Avalyn Quality Management function to develop and maintain quality management systems to monitor and improve the quality of clinical operations processes.
• Strategic Partner/Vendor Management: Oversee the selection, evaluation, and management of external partners/vendors, such as contract research organizations (CROs), central laboratories, and other service providers. Establish strong relationships with partners/vendors and negotiate contracts to ensure cost-effectiveness and high-quality deliverables.
• Risk Management: Identify and mitigate risks associated with clinical trials, including protocol deviations, adverse events, and data integrity issues. Implement risk management strategies and develop contingency plans to address potential challenges and ensure patient safety.
• Sponsor Oversight and Clinical Trial Management: Develop and implement clinical trial monitoring standards and best practices for effective monitoring of investigational sites and the overall quality and integrity of each assigned clinical trial or program of trials, in accordance with industry standards and practices.
• Team Development: Operate as “one team” through clear and transparent communications and appropriate team building strategies. Provide mentoring, coaching, and performance feedback to enhance individual and team capabilities. Foster a culture of collaboration, innovation, and continuous improvement.
• Stakeholder Engagement: Collaborate with internal stakeholders, such as senior management, clinical development teams, Key External Experts, and regulatory affairs, to align clinical operations strategies with broader organizational objectives. Establish strong relationships with external stakeholders, including investigators, study sites, and regulatory authorities.
• Data Management and Analysis: Working internally/externally with data operations experts to understand the data collection, analysis, and interpretation of clinical trial data.
• Business Process Improvement: Contribute to the identification of business process improvement needs or opportunities, and lead or participate in strategic and continuous business improvement initiatives in study planning & set up, study conduct & close out, vendor and CRO selection and management, budget development & management, and other initiatives to support Avalyn clinical development needs.
• Personnel Management: Provide direct or indirect line management of clinical operations staff contract or consultant staff on an as-needed basis. Mentor and coach CO and other functional department team members on clinical trial operations.  If in a formal line management role, conduct appropriately timed performance reviews, calibration sessions, and feedback discussions.  Perform competency assessments and suggest approaches to address identified developmental opportunities.
• Collaborate with the VP, Clinical Operations and colleagues from other functional groups with responsibilities in the therapeutic program (Clinical Development, Medical Affairs, Regulatory Affairs, Data Management, Finance, and Program Management) to ensure alignment of resources and tasks management to meet Avalyn business needs and to achieve Avalyn corporate goals.

Qualifications and Requirements:

• Degree required with a degree in life sciences, medicine, pharmacy, or a related field preferred. A Ph.D., M.D., or equivalent is appreciated but not required.
• Extensive experience (typically 10+ years) in clinical operations within the healthcare or pharmaceutical industry, including significant experience in clinical trial management.
• Experience in rare diseases and respiratory diseases/research highly preferred.
• Strong working knowledge of applicable regulatory guidelines and requirements (e.g., FDA, EMA), as well as ICH-GCP and other relevant industry standards.
• Proven leadership and management skills, with the ability to lead and motivate cross-functional teams.
• Excellent organizational, planning, and project management abilities, with the capacity to handle multiple priorities and meet tight deadlines or successfully negotiate modifications.
• Strong problem-solving and decision-making skills, with a focus on driving inspection readiness, continuous improvement, and operational excellence.
• Demonstrated successful experience managing/overseeing Contract Research Organizations (CROs), vendors and other 3^rd party suppliers
• Experience working across all phases of clinical development (Phases I – III; phase IV experience helpful)
• Working medical and scientific knowledge; experience in the Respiratory Therapeutic Area strongly desirable
• Prior experience as Clinical Research Associate (CRA/monitor), Lead CRA, or Project Manager at either Sponsor, CRO helpful but not required
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders at all levels.
• Experience in vendor management and contract negotiation is desirable.
• Familiarity with clinical trial technology and data management systems is an advantage.

Business Requirements:

• Limited business travel domestically and internationally may be required.
• Fully remote position.
• Ability to communicate in English (written and verbal). Fluency to read or speak other languages is beneficial. 

Arcaea is building a new generation of ingredients for the beauty and personal care industry, rooted in biotechnology and designed to deliver high performance with a new standard for sustainability. Our work expands what’s possible in product development and formulation. 

We are seeking a highly organized Project Manager to drive alignment across Creative, Product Development, R&D, Marketing, and Supply Chain for two beauty brands. 

In this role, you will lead cross-functional execution by implementing and streamlining processes, ensuring projects stay on track from concept through launch. You will own timelines, coordinate workstreams, maintain vendor relationships and drive accountability across teams-planning schedules, monitoring progress, and ensuring delivery on time and within budget. 

WHAT YOU’LL DO

• End to End Launch Management: Own the project lifecycle for new product development; from, formula development, packaging, merchandise creation, as well as promotional and seasonal campaigns.
• Cross Functional Orchestration: Lead weekly status meetings to sync teamwork flows, as well as high level NPD risk mitigation meetings. 
• Timeline & Risk Governance: Develop detailed schedules using Monday.com and Smartsheet to identify the critical path. Proactively identify bottlenecks and develop "Plan B" scenarios to mitigate risk. 
• Process Ownership: Utilizing PageProof, an online proofing software, to manage the review and approval process of creative artwork  to ensure 100% routing compliance. Handle essential administrative tasks including NDA routing, system onboarding, and process integration.
• Vendor & Partner Liaison: Communicate with external partners and packaging manufacturers to track production milestones. Manage new vendors through development prior to transitioning to the Supply Chain team for mass production coordination.  
• Stakeholder Communication: Maintain project dashboards and prepare status reports for leadership to provide visibility on progress, risks, and outcomes.
• Hands on Execution: Support technical teams as needed, including shipping samples, unpacking deliveries, creating mock-ups, and ad hoc small packaging tests.

WHAT WE SEEK

• 5+ years of Project Management experience within the Beauty industry.
• Hybrid schedule 3 days a week in office with core hours of 10am-4pm, 2 days of focused work from home.
• Deep understanding of beauty specific workflows, including primary/secondary packaging, safety testing, regulatory requirements, and claims testing.
• Expert-level proficiency in project management software Smartsheet, Monday.com, Google Workspace/Microsoft 365 suites.
• Proven ability to deliver technical programs from inception to delivery while navigating the ambiguity of a fast-paced startup environment.
• Exceptional diplomatic skills; ability to hold teams accountable and "manage up" while maintaining a positive, collaborative culture.
• Ability to manage multiple concurrent major projects/programs for both short and long term goals.
• A talent for working independently in a fast-paced environment, navigating ambiguity, and creating clarity where needed.
• Excellent trade-off management in achieving tactical and strategic objectives.
• Comfort in setting context (urgency, dependencies, and goals) and working with teams to determine milestones.

About Formlabs:

Do you want to change how the world creates?

At Formlabs, we’re building the tools that make it possible for anyone to bring their ideas to life, from cutting-edge products to life-saving medical devices. Our 3D printing technology powers innovation at more than 50,000 industry leaders worldwide, including Apple, Google, Tesla, New Balance, and NASA. Together, we’re helping everyone design, prototype, and manufacture faster than ever before.

We’re a team of hands-on builders, engineers, and innovators reinventing how the world makes physical things. If you’re ready to shape the future of fabrication, come build it with us.

Your Impact: 

Materials development presents one of the greatest opportunities to innovate in 3D printing, unlocking new applications in different industries such as engineering, consumer, manufacturing, automotive and healthcare. Our materials science team works closely with product management, hardware and software teams to develop new materials that push the boundaries of what can be done with 3D printing.

If you are a scientist or engineer with experience in polymer development who’s excited to break new ground in an industry that’s moving at lightning speed, we want you as a Materials Scientist - Photopolymer Development!

What You’ll Do:

• Design and optimize complex photopolymer formulations to push the boundaries of additive manufacturing.
• Lead the end-to-end transition of new materials from lab scale concept to commercial launch, supporting technology transfer and scale-up.
• Establish structure-process-property relationships through rigorous experimentation and analytical characterization to meet demanding product specifications.
• Learn about the 3D printing process and underlying hardware, and use that knowledge to inform formulation decisions and provide input to future hardware decisions.
• Collaborate cross-functionally with product management, hardware, and software teams to develop products that meet customer needs and work seamlessly on the Form 4 platform.

About You:

• BS, MS, or PhD in polymer science, chemical engineering, chemistry, materials science or a related field.
• Results-oriented and motivated by delivering products in a fast-paced R&D environment.
• Experience developing thermoset materials including epoxies, urethanes, or acrylates.
• Enjoys working hands-on in the lab conducting experiments and analyzing large data sets to drive decision making.
• Able to work autonomously and push projects forward with a high level of independence. 
• Track record of success including publication, IP generation, or product commercialization.
• Practices good documentation and can organize complex data, create SOPs, and write clear, detailed internal reports.

Bonus Skills:

• Familiarity with additive manufacturing technologies
• Programming and digital analysis (Python, JMP, MATLAB, Minitab etc)
• Experience with high performance polymers, composites, or elastomers

Our Perks:

• Robust equity program to build future wealth through RSUs
• Comprehensive healthcare coverage (Medical, Dental, Vision)
• 401K matching and access to financial advisors
• Generous paid Parental Leave (up to 16 weeks)
• Tenure-based paid Sabbatical Leave (up to 6 weeks)
• Flexible Out of Office Plan – Take time when you need it
• Ample on-site parking & pre-tax commuter benefits
• Healthy on-site lunches, snacks, beverages, & treats
• Regular sponsored professional development opportunities
• Many opt-in culture events across our diverse community
• And of course… unlimited 3D prints

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Even if you don't check every box, but see yourself contributing, please apply. Help us build an inclusive community that will change the face of 3D printing.

Who Are We?

Brooke Charter Schools is a network of four public charter schools, serving grades K-12 in Mattapan, Roslindale, and East Boston. At Brooke, we coach and invest in our teachers so that they can help our students achieve at the highest levels and graduate from college. We believe academic achievement empowers our students to live choice-filled lives and enhances their ability to contribute to creating a just world. In a culture of achievement, educators support students in recognizing and building on their identities as sources of strength even as they work to grow and achieve in new ways. 

What is the School Nurse Role? 

• Supervise school procedures for dispensing student medication as needed and according to federal, state, local, and school guidelines
• Conduct medical screenings as required by law, including, but not necessarily limited to, hearing, vision, teeth, growth, weight, and scoliosis screenings
• Treating students who have been referred to the nurse’s office and maintain a daily nursing log of students seen for any medical reason
• Assist with first aid procedures for medical emergencies at our school
• Maintain medication supply for each student and provide for daily administration of medication including for students on psychotropic medication requiring special administration
• Maintain contact with prescribing doctors and with parents / guardians to insure correct prescriptions are followed
• Maintain, track, and update all required student medical records, including appropriate written data covering all medical needs and services provided to our students
• Maintain and update health administration database
• Insure classroom teachers have protective first aid equipment and access to health supplies needed for routine classroom mishaps
• Communicate with families regarding matters regarding student health and student medical records
• Promote and assist in the control of communicable diseases through prevention, early detection, surveillance, and reporting of contagious diseases to the appropriate local health authority
• Assist in the formulation of health policies, goals and objectives for the Brooke Schools
• Assist in assessing potential abuse and neglect issues, and contribute to IEP development where medical issues, alerts are involved
• Counsel students on sexual health and nutrition as needed
• Contribute to the creation of advisory lessons related to healthy relationships, sexual health, drug abuse and nutrition.
• Other such duties as the Director of Operations may from time to time request commensurate with the employee’s position

Standard working hours are 7:15AM-4:20PM. Salaries for this role are commensurate with experience ranging from $78K - $122,880 (depending upon years of experience). 

Is This You? 

• You hold an RN license
• You believe that great teaching closes the achievement gap and have an unwavering belief in our students' capabilities 
•  You are committed to fostering diversity by cultivating anti-racist practices and removing bias, empowering students with the resources they need to create choice filled lives for themselves and their futures.  Read more about how we are working on this at Brooke here.
• You are professional, warm, and emotionally composed with students, families, and colleagues
• You are a team player with strong organizational skills who craves feedback and opportunities for growth 
• Proficient in Google Suite and Microsoft Office (e.g. Microsoft Word, Excel)
• Flexible start date (earlier preferred; no later than July 22, 2026)

The community and students we serve are diverse, and we are committed to reflecting that diversity in our staff. We strive to have the most diverse applicant pool possible; to that end, we encourage individuals of all backgrounds to apply for any position at Brooke Charter Schools. By fostering a diverse and inclusive environment, we provide the best educational experience to prepare our students for a future reflective of the world we live in.

SES AI Corp. (NYSE: SES) is dedicated to accelerating the world’s energy transition through groundbreaking material discovery and advanced battery management. We are at the forefront of revolutionizing battery creation, pioneering the integration of cutting-edge machine learning into our research and development. Our AI-enhanced, high-energy-density and high-power-density Li-Metal and Li-ion batteries are unique; they are the first in the world to utilize electrolyte materials discovered by AI. This powerful combination of "AI for science" and material engineering enables batteries that can be used across various applications, including transportation (land and air), energy storage, robotics, and drones. 

 To learn more about us, please visit: www.ses.ai 

What We Offer: 

• A highly competitive salary and robust benefits package, including comprehensive health coverage and an attractive equity/stock options program within our NYSE-listed company. 

• The opportunity to contribute directly to a meaningful scientific project—accelerating the global energy transition—with a clear and broad public impact. 

• Work in a dynamic, collaborative, and innovative environment at the intersection of AI and material science, driving the next generation of battery technology. 

• Significant opportunities for professional growth and career development as you work alongside leading experts in AI, R&D, and engineering. 

• Access to state-of-the-art facilities and proprietary technologies are used to discover and deploy AI-enhanced battery solutions. 

What we Need: 

The SES AI Hermes team is seeking an exceptional Battery Electrolyte Scientist & Materials Chemistry Leader to serve as an R&D leader specializing in electrolyte development and interfacial chemistry. This role is critical for producing experimentally validated battery component data, guiding AI model training, and defining the materials innovation roadmap for next-generation energy storage systems. As an Electrolyte Scientist and R&D Leader, you will direct key experimental programs and manage the strategic interface between chemistry and AI. 

Essential Duties and Responsibilities: 

• R&D Program Leadership 

• Direct complex electrolyte R&D programs focused on next-generation battery systems, ensuring alignment with customer and product requirements (e.g., safety, cyclability, low/high temperature performance). 

• Lead multi-R&D teams composed of chemists, data scientists, and engineers to achieve key innovation milestones. 

• Define the materials innovation roadmap, particularly related to electrolyte formulation and interfacial science. 
   

• Experimental Validation & Data Generation 

• Oversee SEI (Solid Electrolyte Interphase) engineering and additive optimization programs, leveraging expertise in fundamental materials chemistry. 

• Lead cell-level validation and the integration of new electrolytes into prototype cells. 

• Produce high-quality, experimentally validated battery component data, guiding AI model training by ensuring data quality, experimental reproducibility, and comprehensive parameter space coverage (Data-driven experimentation). 
   

• AI Integration & Tools 

• Utilize molecular informatic tools to accelerate battery component optimization cycles, effectively bridging experimental data with AI-generated candidates. 
   

Education and/or Experience: 

• Education: Ph.D. in Materials Science and Engineering, Chemical Engineering, Electrochemistry, or a closely related materials chemistry field. 

• R&D Leadership: Proven background as an electrochemical researcher and R&D leader experienced in directing technical programs and managing multi-disciplinary research teams. 

• Core Chemistry Expertise: Deep expertise in fundamental materials chemistry, interfacial science, additive optimization, and Solid-Electrolyte Interphase (SEI) engineering. 

• Validation Experience: Extensive experience in cell-level validation and advanced characterization techniques, demonstrating an ability to integrate new materials into prototype cells. 

• Data Focus: Demonstrated experience in data-driven experimentation and structuring chemistry data for AI model consumption. 
   

Preferred Qualifications: 

• Industry Focus: Previous experience at leading battery manufacturers, electrolyte R&D teams, or applied materials chemistry labs, especially those focused on next-generation battery and energy storage systems. 

• Program Alignment: Strong track record of successfully aligning R&D execution with clear customer and product requirements. 

• Informatics Tooling: Ability to use or integrate results from molecular informatic tools for component optimization. 

About Us:

SES AI Corp. (NYSE: SES) is dedicated to accelerating the world’s energy transition through groundbreaking material discovery and advanced battery management. We are at the forefront of revolutionizing battery creation, pioneering the integration of cutting-edge machine learning into our research and development. Our AI-enhanced, high-energy-density and high-power-density Li-Metal and Li-ion batteries are unique; they are the first in the world to utilize electrolyte materials discovered by AI. This powerful combination of "AI for science" and material engineering enables batteries that can be used across various applications, including transportation (land and air), energy storage, robotics, and drones.

To learn more about us, please visit: www.ses.ai

What We Offer:

• A highly competitive salary and robust benefits package, including comprehensive health coverage and an attractive equity/stock options program within our NYSE-listed company.
• The opportunity to contribute directly to a meaningful scientific project—accelerating the global energy transition—with a clear and broad public impact.
• Work in a dynamic, collaborative, and innovative environment at the intersection of AI and material science, driving the next generation of battery technology.
• Significant opportunities for professional growth and career development as you work alongside leading experts in AI, R&D, and engineering.
• Access to state-of-the-art facilities and proprietary technologies are used to discover and deploy AI-enhanced battery solutions.

What we Need:

The SES AI Department is seeking an Electrolyte Scientist to join our team dedicated to mobile energy storage. This scientist will be responsible for creating innovative electrolyte materials and systems that enable safe, long-lasting, and high-energy-density lithium-ion batteries. Key duties include designing, developing, and optimizing electrolyte formulations, as well as meticulously analyzing their interactions with other cell components during battery cycling and storage. The ideal candidate is a passionate, highly detail-oriented, and collaborative team player who thrives in a fast-paced environment and shares a vision for advancing energy storage technology.

Essential Duties and Responsibilities:

• Formulation and Materials Design
  • Design and develop electrolyte formulations compatible with high energy density lithium-ion anodes and high nickel content NMC cathode cell chemistries to achieve a long cycle life safely.
  • Design electrolyte systems to demonstrate improvements in safety performance, including dimensional stability during battery cycling and storage.
  • Provide technical assessment on existing electrolyte systems, additives, and lithium salts in high energy, high-capacity rechargeable lithium-ion cells.
    
    
• Electrochemical Characterization and Analysis
  • Fully characterize coin and pouch cell performance using new materials and formulations.
  • Utilize electrochemical testing and analytical techniques to understand reaction mechanisms, failure modes, and potential benefits of new formulations.
  • Demonstrate the ability to use fundamental physical chemistry concepts and experimental techniques to provide promising electrolyte formulation strategies.
    
    
• Project Management, Communication, and Leadership
  • Ability to independently plan, execute, manage, and communicate progress on projects.
  • Support product development as required for the prototype-manufacturing team.
  • Process Optimization: Design and implement streamlined testing metrics (e.g., Design of Experiments - DoE) to significantly shorten the R&D learning and development cycle.
  • Communication & Insight: Effectively communicate new concepts, findings, and project updates to the team, drawing actionable insights from discussions.
  • Technical Leadership: Serve as a technical mentor and leader to junior staff, guiding experimental design and professional development.
  • Knowledge Integration: Actively integrate and synthesize existing in-house knowledge with new discoveries to accelerate development and problem-solving.
  • IP Development: Proactively contribute to the company's intellectual property portfolio through invention disclosures and patent applications.
    
    

Education and/or Experience:

• Scientific Knowledge: MS (or better) level of understanding in Electrochemistry, Materials Science, Chemical Engineering, or a related physical science field.
• Experience with developing semi-solid electrolytes (e.g. in-situ gel polymer electrolyte, polymer electrolyte, hybrid solid/liquid electrolyte) are highly preferred. 
• Experience Level: Minimum of 3+ years of industrial or advanced academic experience (post-MS) focused on electrolyte or battery materials development.
• Chemistry Foundation: Strong knowledge of common lithium-ion electrolyte systems, including common lithium salts, solvents, and additives, and their specific roles.
• Physicochemical Understanding: Experience applying physical-chemical methods to tackle formulation problems and understanding properties like density, viscosity, and ionic conductivity.
• Electrochemical Techniques: Hands-on expertise in advanced electrochemical characterization, including Electrochemical Impedance Spectroscopy (EIS) and galvanostatic cycling.
• High-Purity Handling: Proven experience working with moisture sensitive materials in a glovebox or dry room environment, and expertise in handling high purity chemicals.
• Data Proficiency: Proficiency in battery cell tests (coin/pouch) and scientific data analysis (e.g., using statistical or scientific software).
• Industry Knowledge: Proven ability to onboard and integrate existing in-house knowledge with new discoveries and challenges.
  
  

Preferred Qualifications:

• Advanced Degree: Doctorate (Ph.D.) in Chemistry, Chemical Engineering, or a related field, with 3+ years of post-PhD industrial experience.
• Diverse Formulation: Experience in formulation development beyond liquid electrolytes, including exposure to polymer electrolytes, ionic liquids, and/or solid-state electrolytes.
• Large Format Experience: Direct experience working with and characterizing large format cells (e.g., prismatic or cylindrical).
• Software/Modeling: Experience with computational chemistry or battery modeling tools.
• Industry Alignment: Demonstrated passion for and experience in the mobile energy or automotive space.

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure, as well as several earlier stage assets. Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs.

Purpose/Summary:

This position is responsible for all aspects of Chemistry, Manufacturing, and Controls (CMC) drug product development from early stage to late-stage clinical development and commercialization, including development of efficient and scalable manufacturing processes, technology transfer, manufacturing of clinical supplies, and management of supply chain for clinical supplies. She/he is also responsible for preparation and review of all CMC regulatory filings. 

At this stage, the primary activities are focused on supporting Phase 3 clinical trials, including manufacturing clinical supplies, managing resupply needs, and overseeing the clinical trial supply chain and drug/device combination product interface.

The Head of Drug Product Development leads activities of an internal multifunctional team and network of external Contract Development and Manufacturing Organization (CDMO) partners working on all aspects of CMC development.  Functional responsibilities as project leader include formulation and manufacturing process development, oversight of drug product development, technology transfer and scale-up, and oversight of packaging and labeling, clinical supply chain, and CMC project management for drug product and drug/device combination product interface related activities.  Must possess strong leadership experience including strong CMC expertise and good technical understanding of the inter-disciplinary nature of drug development demonstrated by previous experience with injectables and drug/device combination products. She/he will collaborate closely with cross-functional internal and primarily external (CDMOs) team members in CMC development, Regulatory, Quality, Clinical Operations and Development during all phases of product development Ph 1- Ph 3, technology transfer, validation, manufacturing and filing IND, IMPD, NDA, MAA registration.

Essential Functions:

• Lead internal and CDMO Drug Product teams and represent Drug Product Development in multidisciplinary project teams as a project leader, work collaboratively to ensure project progression, and communicate Tech Ops strategy and related challenges.
• Encourage innovative, cross-functional thinking, and engagement of outside expertise as appropriate to help further Tech Ops/Corporate goals
• Ensure robust planning and execution of product development efforts across Ironwood's portfolio of development candidates from IND, Ph1, Ph2, Ph3 to commercialization. Proactively identify and mitigate risks to advance products in a timely manner.
• Ensure effective communication with key partners internally (particularly program management, regulatory, clinical development, and quality) and with an external CDMO network.
• Set Drug Product team budget and have financial accountability for drug product development activities per the annual operating plan.
• Responsible for Drug Product CDMOs timelines and Drug Product functional planning by providing technical oversight to ensure that Ironwood’s development and clinical manufacturing needs are met.
• Provide oversight to the clinical trial supplies team managing the inventory/delivery of Investigational products.
• Apply formulation and manufacturing principles, theories, and techniques to product development, and ensure development of the best possible phase-appropriate formulations.
• Supervise Drug Product and Clinical trial Supply scientists internally and externally to deliver on chemical, formulation, and analytical drug product development goals.
• Enable risk-based and compliant development practices: Identify and evaluate risks and provide recommendations to close via internal or external collaborations. Ensure development activities are documented per Ironwood documentation policies and underlying data are traceable.
• Author and/or review technical reports and relevant CMC sections for regulatory submissions (INDs, IMPDs, NDAs, etc.). Accountable for content development of FDA and exUS regulatory filings in collaboration with Regulatory, Quality, Supply Chain and members of the Development teams.

Requirements:

• PhD in pharmaceutical sciences, chemical or biochemical engineering, chemistry, or related scientific field with at least 15 years of industrial experience with at least 10 years of senior leadership experience in leading CMC/formulation teams especially in the injectable space (more specifically vials, both liquid and lyophilized drug products).
• Experience with injectable drug products containing synthetic peptides.
• Experience with leading drug product teams for injectable products during Phase 3, process validation, launch readiness and transition to commercial production.
• Experience with early phase development (pre-clinical, and Phase 1) a plus.
• Demonstrated experience supporting drug–device combination product development, with specific expertise in fill‑finish processes (e.g., prefilled syringe, autoinjector, dual-chamber cartridge) and conducting drug product–device / container compatibility evaluations.
• Experience with clinical studies and supply chain management oversight a plus.
• Comprehensive understanding of all aspects of CMC including process and formulation development, analytical science, regulatory, and quality.
• Strong group leadership, communication, and collaborative skills (both cross-department and with development partners). Experience working with global teams is strongly desired 
• Experience in managing development and manufacturing activities at global CDMOs
• Experience with synthetic peptide manufacturing processes, injectable drug product manufacturing, and finished goods primary packaging 
• Working knowledge of approaches for characterization of solution and solid-state properties of materials, and technologies for delivery of synthetic peptides
• Excellent data analysis skills and the ability to make recommendations that impact the scientific and business goals of the company. Ability to articulate complex issues and ideas with clarity to enable understanding and direction.
• Solid understanding of ICH, FDA, EMEA and USP guidelines is essential, including the ability to apply the guidelines in context of the stage of product development
• Strong understanding of drug–device combination product development, including primary container interactions, fill‑finish considerations, and drug product–device compatibility
• Experience with submissions and interactions with regulatory agencies regarding CMC issues during product development and primary container/packaging for drug-device combination products. Thorough knowledge of INDs, IMPDs, MAAs, NDAs, etc.
• The ability to work successfully in both a team/matrix environment as well as independently is required
• The ability to influence cross-functionally to enable development improvements and team performance.
• Good communication, project management, and interpersonal skills
• Effective and innovative problem-solving skills

Ironwood Pharmaceuticals is an equal opportunity employer welcoming diversity in our workforce.

Ironwood currently anticipates that the initial base salary for this position could range from between $246,000 to $286,650.  The actual base salary will depend, in part, on the successful candidate’s qualifications for the role, including education and experience.  Ironwood offers a comprehensive compensation and benefits program to eligible employees, including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical, dental, vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule.

#LI-Hybrid

Company Overview:

Strand Therapeutics is a clinical stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies to patients.

Building on the idea of creating smart therapies based on Boolean logic circuits, Strand was started by biological engineers working together at MIT who were seeking to apply the concept of the emerging field of mRNA therapeutics. Strand's technology is therapeutic-area and mRNA modality agnostic where therapeutic proteins are encoded onto modified, self-replicating, or circular mRNA backbones which in turn are programmed with cell-specific sensors and circuits.

Today, Strand has established three platforms with one clinical stage asset and several programs in preclinical development as well as early discovery. Our lead program, STX-001, is currently being evaluated in a phase 1 clinical trial for solid tumors. Our corporate headquarters is located in the Fenway district of Boston, Massachusetts.

Become the next standout single strand!

Job Summary:

Strand is looking for people who have the enthusiasm and motivation to be a highly contributing member of a small but extremely productive team. This opportunity will offer the employee the ability to work in a matrix-based environment and be a part of the future strategy of the company.

We are looking for a highly motivated and innovative candidate for the role of Associate Scientist II / Senior Associate Scientist of Nanoparticle Process Development. This individual will support in production and scale up of LNPs with nucleic acid payload. Reporting to the Principal Scientist of Nanoparticle Process Development, the right candidate will be a strategic thinker that brings a leadership presence and enthusiasm for Strand along with deep scientific knowledge.

Primary Responsibilities:

• Execute experiments related to LNP mixing and downstream purification/filtration to improve the process.
• Contribute to development of a robust formulation process with emphasis on scale-up, tech-transfer and stability.
• Contribute to thorough characterization of LNPs by existing methods and collaborating with internal stakeholders on developing new methods.
• Coordination with other team members to support the group's research activities in a fast-paced and collaborative environment.

Qualifications:

• B.S. with at least 2-5+ years of relevant experience or M.S. with at least 1-3+ year of relevant experience with an educational focus in Chemical Engineering, Bioengineering or similar preferred.
• Experience with LNPs required and nucleic acid payloads required.
• Experience with TFF required with emphasis on LNPs highly preferred for Associate Scientist II level, required for Senior Associate Scientist level.
• Experience with QbD principles, scale up efforts and JMP DOE is a plus.
• Experience with various mixing geometries as well large scale LNP production preferred for Associate Scientist II level, required for Senior Associate Scientist level.
• Strong collaboration and inter-personal skills.
• Ability to multi-task and prioritize to meet important deadlines.

Strand offers a fast-paced, entrepreneurial, team-focused small company environment. We also offer a top-notch benefits package (health, dental, life, open PTO, onsite lunch catering, commuter support and more) and work/life flexibility and integration. Being part of the Strand team allows you to become part of a small team that supports professional development while working together to meet Strand’s goals. 

Strand Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Strand does not accept unsolicited resumes from any source other than directly from candidates.

Job Type: Full-time

Salary: $84,000 - $100,000 annually plus bonus and equity incentives