Your Impact at LILA

Lila Sciences is seeking Platform Scientists, Soft Materials Focus to ideate, prototype, and transfer new experimental concepts for AI Science Factories targeting complex and soft material systems. In this role, you will work at the forefront of scientific ideation—partnering with a broad range of chemistry, materials, and AI teams to define new approaches to formulation, structure–property relationships, and performance evaluation. You will translate these concepts into scalable experimental workflows, custom apparatus, and software-enabled systems for autonomous research.

What You'll Be Building

• Collaborate with diverse scientific teams to ideate new experimental strategies for soft and complex materials, including formulations, colloids, polymers, gels, and biological or hybrid systems
• Lead conceptual development of characterization and performance workflows leveraging techniques such as SAXS, SANS, rheology, and formulation performance assays
• Design, prototype, and validate custom apparatus, experimental methods, and software tools to realize these concepts
• Develop and refine workflows that connect structure, dynamics, and performance across multiple length and time scales
• Transfer successful prototypes into production-ready systems within Lila’s AI Science Factory platform, enabling autonomous experimentation

What You’ll Need to Succeed

• MS or PhD in Materials Science, Chemistry, Chemical Engineering, Physics, or a related field, with a focus on soft or complex materials
• Demonstrated experience collaborating across scientific disciplines to generate and refine experimental concepts
• Hands-on experience with one or more of the following: SAXS, SANS, rheology, formulation performance or functional assays
• Experience designing and implementing custom experimental workflows and/or scientific software
• Strong programming skills (e.g., Python, C++, or similar) applied to data analysis, automation, or experiment control
• Excellent communication skills and comfort operating in a fast-paced, exploratory R&D environment

Bonus Points For

• Experience with lab automation, high-throughput experimentation, or instrument control software
• Background in formulation science (e.g., consumer products, coatings, energy materials, bio-soft matter)
• Experience linking scattering, rheological, and performance data to predictive or ML-driven models
• Familiarity with prototyping tools such as 3D printing, machining, microfluidics, or custom sample environments
• Industry or national lab experience working on soft materials or complex fluids

About Sail 

Sail Biomedicines is pioneering the integrative design and deployment of fully programmable medicines to transform patient care. Sail’s platform combines first-in-class programmable circular RNA technology (Endless RNA™ or eRNA), and an industry-leading platform of programmable nanoparticles, utilizing natural components, to unlock comprehensive programming of medicines for the first time. By leveraging cutting-edge eRNA and nanoparticle deployment technology, Sail is also making unparalleled use of AI techniques to identify and design fully programmable medicines that are potent, targeted, versatile, and tunable. Sail was founded by Flagship Pioneering. 

The Role

The Sr Director, Delivery will be responsible for advancing Sail’s targeted nanoparticle delivery platform, with a particular focus on lipid nanoparticle (LNP) technologies for cell-specific delivery of RNA therapeutics. This role will lead the strategy and execution of delivery innovation from early discovery through preclinical development, enabling robust, scalable, and translatable delivery solutions across Sail’s pipeline.

This individual will bring deep technical expertise in lipid nanoparticle design and formulation, as well as demonstrated experience in targeted delivery approaches, including ligand-mediated targeting, bioconjugation, and receptor-specific delivery strategies. They will play a central role in shaping Sail’s delivery capabilities, expanding tissue and cell-type reach, and unlocking new therapeutic applications.

The Sr Director will operate at the intersection of Platform, Programs and Technical Development, working cross-functionally to translate delivery innovations into high-impact programs. They will lead a team of scientists and serve as a key thought partner to senior leadership on delivery strategy, platform investments, portfolio prioritization, and technical risk.

This role is accountable for the foundational and Delivery capability at Sail, ensuring that targeted nanoparticle systems are not only innovative but also translatable and scalable, enabling continued pipeline progression to development candidates.

Responsibilities 

Delivery Leadership and Strategy

• Lead and grow Sail’s Delivery team, advancing lipid nanoparticle (LNP) and targeted delivery technologies.
• Drive innovation in targeted nanoparticles, including design, formulation, ligand selection and conjugation, receptor-mediated uptake, and cytosolic delivery.
• Define and execute delivery strategy across tissues and disease areas, guiding nanoparticle engineering for precise targeting and biodistribution.
• Develop and apply high-throughput screening approaches to evaluate delivery performance, including biodistribution, cellular uptake, and functional expression.
• Partner with Program teams to advance multiple development candidates, improving efficiency, specificity, and translatability.
• Partner with Technical Development to ensure scalable, robust processes supporting progression to clinic.

Cross-Functional & Operational Leadership

• Lead cross-functional delivery efforts to advance programs from concept through candidate nomination.
• Collaborate with ligand design and program teams to align delivery strategies with disease biology and therapeutic goals.
• Identify and mitigate key delivery risks to enable program success.
• Drive integrated planning across delivery activities, aligning timelines, milestones, and resources.
• Manage external collaborations, including CROs and technology partners.
• Advise senior leadership on delivery strategy, portfolio prioritization, and execution risks.

Qualifications

• PhD or MD in drug delivery, chemical engineering, materials science, pharmaceutical sciences, or a related discipline with 12+ years of relevant industry experience.
• Deep expertise in lipid nanoparticle (LNP) systems, including formulation development, lipid chemistry, and in vitro/in vivo evaluation of delivery performance.
• Demonstrated experience in targeted delivery approaches, including ligand conjugation, receptor-mediated targeting, and nanoparticle surface engineering.
• Strong understanding of nucleic acid delivery challenges, including biodistribution, cellular uptake, endosomal escape, and immunogenicity.
• Experience advancing delivery technologies toward IND-enabling studies or clinical translation, with an appreciation for scalability, manufacturability, and regulatory considerations.
• Proven track record of advancing delivery technologies from discovery through preclinical development.
• Experience building and leading multidisciplinary scientific teams in a fast-paced biotech environment.
• Ability to operate strategically while remaining deeply connected to scientific detail and execution.
• Strong cross-functional leadership skills, with experience working across chemistry, biology, process development, and translational teams.
• Excellent communication skills, with the ability to influence senior stakeholders and clearly articulate complex technical concepts.

Salary Range: $235,000 - $290,000 

Sail Biomedicines is an Equal Opportunity Employer. Sail does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, national origin, veteran status, or any other status protected under federal, state, or local law. 

The Opportunity:

As part of the Pharmaceutical Development team, this position will play a key role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs.

Your Role: 

• You will serve as CMC-regulatory lead for assigned projects.
• Develop and execute CMC global submission plans and timelines in accordance with project goals
• You will lead the preparation/plans, review, and on-time submission of CMC sections for IND/IMPD/CTA, NDA/MAA and other global regulatory filings including IB, DSUR, annual updates, briefing books etc. in conjunction with regulatory affairs and CMC/Pharmaceutical Development leads/SMEs.
• You will be responsible for coordination of responses to CMC questions/RFIs from regulatory authorities in conjunction with CMC and regulatory affairs leads/SMEs.
• You will lead CMC-regulatory activities listed above with cross-functional teams and act as the regulatory CMC liaison between CMC/PD, regulatory affairs and/or program management, as applicable.
• You will lead and manage CMC-regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations, in conjunction and consultation with CMC leadership.
• You will keep abreast of regulatory guidance and technical/scientific developments relevant to projects.

Competencies:

• Strong background in Regulatory Affairs-CMC with a focus on small molecule clinical (IND/IMPD) and/or commercial (NDA/MAA) submissions.
• Proven ability to lead and manage regulatory CMC projects with minimal supervision
• In-depth knowledge of global CMC regulatory requirements and guidelines (e.g. FDA, EMA, ICH).
• Positive attitude, energetic and proactive.
• Strong technical writing and document review skills.
• Excellent organizational skills, ability to multi-task and prioritize assignments, operational creativity, strong problem-solving skills, self-motivated and able to work under pressure.
• Strategic thinking capabilities with forward looking perspective and ability to find solutions, in alignment with management and program goals, strong communication, planning, and collaboration skills
• Attention to detail, follow-up/through skills; ability to work individually and within multi-disciplinary internal and external teams at third parties.
• Ability to effectively manage multiple projects with competing priorities.

Your Qualifications:

• Bachelor or advanced degree in Pharmaceutical Sciences, Chemistry or related fields.
• Minimum of 8+ years of relevant experience in regulatory-CMC and/or within CMC function (e.g. analytical, formulation and process development, QA, QC) in the biotech/pharmaceutical industry with a focus preferably on CMC for small molecules and oral solid products.
• Experience with authoring/review/providing CMC content for CMC/quality submissions including IND and IMPD development/maintenance.
• Knowledge of eCTD Module 3 and QOS requirements for INDs/IMPDs and NDAs/MAAs.
• Experience managing submissions in RIM Veeva or equivalent; document formatting/Quality Control compliant with eCTD templates / requirements.
• Authoring experience of CTD Module 2 & Module 3 sections.

Estimated Salary Range: [$145,000 - $207,000].

The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.

#BP1

Prime Medicine was founded to bring the promise of gene editing to patients. We use Prime Editing, a next-generation technology that can “search and replace” to restore normal genetic function almost anywhere in the genome. Prime Editing searches to find the precise place in the genome to edit and replaces the segment of faulty DNA with a correct copy of DNA.  A single Prime Editor can correct the individual mutations found across patients, meaning Prime Editing can potentially address more than 90 percent of known disease-causing genetic mutations. 

We envision a world where this technology can cure, halt, and ultimately prevent genetic diseases, providing lifelong benefit to patients.  Prime Medicine offers the opportunity to shape the future of gene editing and transform how medicines are used to treat disease. Realizing the promise of Prime Editing requires a talented team with diversity of viewpoints and expertise. We’re building a group of dedicated, scientifically curious individuals who are passionate about helping patients live longer, healthier lives.

Position Overview

Prime Medicine is seeking a talented and motivated Sr. Manager to join the Analytical Development & QC team within Technology, Development & Operations. This role will focus on Quality Control (QC) related activities for all programs, including management and technical oversight of tech transfer, qualification/validation and release and stability testing carried out at both CDMOs, CTLs and internally at Prime for our prime editing ex vivo cell therapy and in vivo LNP-based drug products.

The successful candidate will have deep understanding of method lifecycle management, including method optimization, qualification, validation/verification, transfer, and implementation in a cGMP environment, as well as previous hands-on experience in at least some aspects of the above. This is a role requiring strong cross-functional collaboration with Analytical Development, Quality, Process Development, Formulation, Informatics, and external partners (CTLs/CDMOs). 

The ideal candidate thrives in a matrixed, fast-paced environment, works effectively with limited supervision, and demonstrates strong technical ownership and execution.

Key Responsibilities

• Design or review analytical procedures and protocols supporting method lifecycle activities, including optimization, qualification, validation, transfer, verification, performance monitoring, bridging, and comparability studies
• Manage and conduct select release, stability, and in-process testing for drug substances, drug products, and gene-editing components, and carry out data analysis and trending
• Support and/or manage analytical method transfer to CTLs/CDMOs, providing oversight, troubleshooting, and ensuring technical and timeline objectives are met
• Manage GMP sample inventory and chain-of-custody documentation
• Lead, manage and maintain well-designed stability programs and reference standard programs
• Author and review protocols, reports, SOPs, and analytical sections of regulatory submissions
• Familiarity with and ability to learn and use new tools for productivity, project management, documentation, tracking scheduling, and data management.
• Support IQ/OQ/PQ of QC equipment and ensure compliance with 21 CFR Part 11
• Maintain GxP-compliant electronic documentation and thorough laboratory records
• Collaborate with Quality to ensure data integrity, regulatory compliance, and audit readiness
• Lead or support investigations, deviations, and root-cause analyses
• Present data and findings to cross-functional teams
• Prepare technical reports and documents for global regulatory submissions

Qualifications

Education & Experience

• BS/MS/PhD in Biochemistry, Molecular biology, Chemistry, Bioengineering, or a related discipline
• Industry experience:
• BS: 10+ years
• MS: 8+ years
• PhD: 3+ years

Technical Expertise

• Experience with analytical method optimization, tech-transfer, qualification, validation, and verification used for critical components, drug substance and drug product release and stability testing
• Hands-on experience with analytical methodologies such as:
• Chromatography-based assays
• Absorbance-based assays
• Cell-based assays
• Compendial assays
• Molecular-based assays
• Flow cytometry assays
• Familiarity with ICH and FDA guidelines for CMC development during clinical stage is required
• Experience in advanced cell and gene-editing therapeutics development is not mandatory, but highly desirable
• Experience working with CMOs/CDMOs is required
• Experience with stability and/or reference standard programs is a plus
• Knowledge of assays, instrumentation, and facility qualification/validation requirements is desirable
• Familiarity with regulatory writing

Personal Attributes

• Highly self-motivated with strong project ownership
• Strong collaborator with internal cross-functional and external partners
• Adaptable in a dynamic, fast-paced environment
• Detail-oriented with strong troubleshooting and problem-solving skills
• Excellent written and verbal communication skills
• Strong abilities to lead and facilitate technical meetings with CDMO and CTL SMEs
• Work with purpose and drive meaningful results
• Ability to innovate and challenge industry status quo
• Ability to travel for up to 5 - 10% of the time

Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, protected veteran status, or any other characteristic protected by law.

COMPANY DESCRIPTION

Flagship Pioneering is a platform innovation company that invents and builds companies that change the world. We bring together the greatest scientific minds with entrepreneurial company builders and assemble the capital to allow them to take courageous leaps. Those big leaps in human health, sustainability and beyond exponentially accelerate scientific progress in areas ranging from disease detection and treatment and nature-positive agriculture to novel applications of AI that are driving the creation of new technologies.   

What sets Flagship apart is our ability to advance science and technology by uniting innovation, company creation, and capital investment under one roof in a way that is largely without precedent. Our scientific founders, entrepreneurial leaders, and professional capital managers are each aligned around an institutionalized process that enables us to innovate and transform for the benefit of people and planet.   

Many of the companies Flagship has founded have addressed humanity’s most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture.  

Flagship has been recognized twice on FORTUNE’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies and has been twice named to Fast Company’s annual list of the World’s Most Innovative Companies. 

THE ROLE

This role will be a foundational hire supporting our formulation and product development efforts, with a primary focus on the development, screening, and optimization of dried powder formulations. The individual will play a critical hands-on role in executing formulation strategies using techniques such as lyophilization and spray drying, while contributing experimental rigor, physical insight, and data-driven decision-making to early-stage platform development.

The Senior Research Associate will work closely with process development partners to produce robust, stable, and scalable powders. In addition to executing experiments, this role will contribute to experimental design, data interpretation, and the establishment of best practices for formulation screening, characterization, and documentation in a fast-moving, early-stage environment.

KEY RESPONSIBILITIES

• Design, execute, and optimize dried powder formulations using lyophilization and spray drying, with a focus on stability, reproducibility, and performance across multiple formulation variables;
• Execute formulation screening efforts using statistically grounded experimental designs (e.g., DoEs), including selection of factors, responses, and experimental conditions, and translate results into actionable next steps;
• Evaluate the impact of excipients, processing conditions, and storage environments on material stability, integrity, and functionality, including under accelerated or stress conditions;
• Characterize dried powder products using appropriate analytical and physical methods (e.g., particle size and morphology, thermal analysis, moisture content, bulk properties) to inform formulation and process decisions;
• Support process development and scale-awareness by documenting critical parameters, identifying sources of variability, and generating data relevant to future scale-up, tech transfer, or external partnerships;
• Maintain clear, rigorous experimental documentation and generate high-quality summaries, figures, and datasets suitable for internal decision-making, patent disclosures, and external communication;
• Contribute to the establishment of long-term formulation workflows, best practices, and standards that support platform development in a small, highly collaborative team.

PROFESSIONAL EXPERIENCE & QUALIFICATIONS 

• Bachelor’s degree (with 5-7 years of relevant research experience) or Master’s degree (with 3-5 years of relevant research experience) in chemistry, chemical engineering, pharmaceutical sciences, materials science, biotechnology, or a related discipline.
• Demonstrated experience with drying-based formulation techniques, including lyophilization and/or spray drying, and an understanding of how process parameters influence solid-state properties;
• Strong grounding in physical chemistry or materials science principles relevant to dried systems, including glass transition behavior, crystallinity, moisture interactions, and excipient effects;
• Experience designing and executing statistically informed experiments (e.g., DoEs), with the ability to interpret interaction effects and use data to guide experimental iteration;
• Familiarity with analytical and characterization techniques for powders and solid-state materials (e.g., DSC, TGA, particle sizing, microscopy, bulk property measurements), and the ability to select fit-for-purpose methods;
• Familiarity with downstream processing operations (e.g., tangential flow filtration and other purification workflows);
• Proven ability to work independently in a dynamic, early-stage research environment, balancing hands-on execution with thoughtful experimental planning and cross-functional communication;
• Strong scientific documentation and communication skills, with experience generating reproducible records and decision-enabling datasets;
• Embodies resilience and scientific rigor in pursuing complex technical questions by iteratively testing hypotheses and refining parameters through uncertainty to converge on robust, optimized solutions.
• Demonstrated curiosity, adaptability, and comfort working across disciplines, with an interest in translating early scientific concepts into robust, scalable technologies.

LOCATION:  Cambridge, MA

ABOUT FLAGSHIP PIONEERING:

Flagship Pioneering invents and builds platform companies, each with the potential for multiple products that transform human health, sustainability and beyond. Since its launch in 2000, Flagship has originated more than 100 companies. Many of these companies have addressed humanity’s most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture.  

Flagship has been recognized twice on FORTUNE’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies and has been twice named to Fast Company’s annual list of the World’s Most Innovative Companies. Learn more about Flagship at www.flagshippioneering.com.

At Flagship, we accept impossible missions to enable bigger leaps. Our core values guide us through uncertainty and toward lasting impact.

We are an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

We recognize that great candidates often bring unique strengths without fulfilling every qualification. If you have some of the experience listed above but not all, please apply anyway. We are dedicated to building diverse and inclusive teams and look forward to learning more about your background and interest in Flagship.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.

#LI-TL1

The salary range for this role is $81,000 - $107,250. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Protocos currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Protocos's good faith estimate as of the date of publication and may be modified in the future.

Your Impact at LILA

What You'll Be Building

• Lead and build a high-performing team of senior scientists, scientists, and research associates focused on nucleic acid delivery technology development.
• Drive the discovery and engineering of targeted lipid nanoparticle systems for delivery of nucleic acid therapeutics.
• Design and evaluate targeting ligands, conjugation strategies, and nanoparticle architectures that enable tissue- and cell-specific delivery.
• Develop and implement innovative biological assays and screening platforms to evaluate delivery efficiency, biodistribution, cellular uptake, and functional nucleic acid expression or editing.
• Leverage the Lila AI platform and AI Science Factory to accelerate design–build–test–learn cycles through AI-driven experimental design and robotics-enabled experimentation.
• Collaborate closely with formulation scientists to integrate biological targeting strategies with lipid chemistry and nanoparticle formulation optimization.
• Explore and evaluate next-generation delivery modalities that extend beyond traditional LNPs.
• Establish strategic scientific direction for nucleic acid delivery research and ensure alignment with company-wide therapeutic goals.
• Foster a culture of innovation, collaboration, and scientific rigor, mentoring team members and developing future leaders in the field.

What You’ll Need to Succeed

• PhD in molecular biology, bioengineering, chemical biology, biomedical engineering, pharmacology, or a related discipline with 8–10+ years of relevant industry or academic experience, or a BS/MS with 12–15+ years of experience in nucleic acid delivery or genetic medicine.
• Demonstrated expertise in lipid nanoparticle technologies, nucleic acid delivery systems, or related genetic medicine platforms.
• Strong track record of scientific leadership and mentorship, including managing multidisciplinary research teams.
• Experience designing and executing in vitro and in vivo assays to measure delivery efficiency, biodistribution, and functional activity of nucleic acid therapeutics.
• Deep understanding of the biological mechanisms underlying delivery, including cellular uptake, endosomal escape, tissue targeting, and intracellular trafficking.
• Experience collaborating across disciplines including formulation chemistry, molecular biology, protein engineering, and pharmacology.
• Track record of impactful scientific contributions demonstrated through publications, patents, or therapeutic development programs.
• Excellent communication and strategic thinking skills with the ability to translate complex scientific ideas into actionable research programs.

Bonus Points For

• Direct experience developing targeted LNP systems or ligand-directed nanoparticle delivery technologies.
• Expertise in RNA therapeutics, gene editing systems (e.g., CRISPR/Cas), siRNA, mRNA, or DNA therapeutics.
• Experience integrating AI-driven discovery tools, high-throughput experimentation, or automated laboratory platforms into biological research.
• Experience working in highly collaborative environments spanning biology, chemistry, computational science, and engineering.
• Demonstrated ability to translate early discovery concepts into therapeutically relevant delivery platforms.
• Entrepreneurial mindset with a passion for pushing the boundaries of AI-enabled scientific discovery.

Your Impact at LILA

We are seeking a (Senior) Research Associate to join our Life Sciences team. This role will focus on formulating lipid nanoparticles (LNPs), functionalizing them with targeting ligands, and characterizing the resulting targeted LNPs (tLNPs). The ideal candidate will have hands-on expertise in LNP formulation and characterization, bioconjugation, protein characterization, and automation technologies. Your work will unlock new understandings in the delivery space by enabling a high-throughput closed-loop screening cascade for tLNPs. This position will work closely with others across the protein, cell biology, automation, chemistry machine learning, and data science teams to help establish high-throughput next-generation tools for targeted nucleic acid delivery.

What You'll Be Building

• Design, execute, and characterize (DLS, ribogreen, TNS, etc.) LNP formulations across multiple scales and mixing modalities
• Develop and refine high-throughput ligand conjugation and purification methods, employing automation and robotics to increase throughput
• Collaborate with cell assay and antibody specialists to screen hits across a variety of tissue targets in in vivo models
• Collaborate with chemists, biologists, engineers, and data scientists to document systems, share insights, and refine best practices in autonomous flow chemistry
• Write, implement, and maintain Standard Operating Procedures (SOPs) for both existing and new lab processes

What You’ll Need to Succeed

• MSc in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or a related field with 3+ years, or BSc with 5+ years, of hands-on experience in targeted LNP production, or related experience. Industry experience strongly preferred
• Strong working knowledge of bioanalytical techniques (e.g., DLS, fluorescence spectroscopy, electrophoresis, in vitro assays)
• Experience with protein and antibody design and characterization
• Familiarity with automation and high-throughput workflows
• Excellent troubleshooting, communication and collaboration skills, with a proven ability to work effectively across interdisciplinary teams

What if... We could harness the power of Flagship’s scientific platforms and create novel treatment options that benefit more patients, sooner?

Pioneering Medicines (PM), an initiative of Flagship Pioneering, is building a world-class biopharmaceutical R&D capability focused on conceiving and developing life-changing treatments for patients by harnessing the power of Flagship's scientific platforms and applying those innovative approaches to serious diseases with unmet medical need. Unique to Pioneering Medicines’ approach is the opportunity to combine platforms to create truly novel and potentially transformative treatments.

Position Summary:

We are seeking an Executive Director, CMC (Chemistry, Manufacturing & Controls) with a proven track record of driving portfolio-level CMC strategy and execution across multiple emerging modality programs simultaneously. This is a senior leadership role operating at the intersection of science, strategy, and operations—requiring the ability to set direction across a complex multimodality pipeline, and build CMC function as a competitive advantage for Pioneering Medicines. This position reports to the SVP, CMC & Technical Operations.

This role will serve as the strategic and operational owner of CMC across the full PM portfolio from research interface through early and late clinical development. This leader will be equally comfortable shaping long-range CMC strategy at the portfolio level and resolving complex technical challenges at the program level. They will define how PM approaches emerging modalities, build and leverage a best-in-class external Contract Development and Manufacturing Organizations (CDMO) network, combined with the strategic acumen to make portfolio-level resourcing decisions. They will be a thought leader in innovative approaches and champion adoption of AI-enabled CMC tools.

Responsibilities:

• Serve as a key member of the Technical Operations leadership team. Lead CMC functions including Drug Substance Development, Drug Delivery / Pre-formulation, Analytical Development, Product Development and Regulatory CMC. Accountability for all aspects of CMC functional strategy and portfolio deliverables.
• Responsible for building and scaling the CMC organization and defining its strategic direction. Recruit, develop, and retain a high-performing CMC team; invest in talent and cultivate a culture of excellence, accountability, and continuous improvement
• Own and drive end-to-end CMC execution across an increasing portfolio of multimodality compounds, ensuring programs advance on time and on strategy; accountable for portfolio-level CMC risk identification, prioritization, and mitigation
• Build and manage a high-performing external CDMO network in partnership with VP, CMC Operations. This includes selection, assessment and establishment of strategic relationships; Maintain a forward-looking view of the CDMO landscape to anticipate portfolio capacity and manufacturing needs
• Oversee the identification, evaluation, and implementation of novel technologies and innovations to drive greater program / portfolio value. Leverage emerging AI-driven technical development, manufacturing and advanced analytics approaches to accelerate CMC timelines and improve efficiency across the portfolio
• Engage and align key stakeholders across Technical Operations, Research, Translational Medicine, and Regulatory Affairs to establish CMC development paradigms, resolve cross-functional trade-offs, and ensure portfolio decisions reflect both scientific rigor and operational reality
• Oversee CMC handoffs and establishing fit-for-purpose development and manufacturing pathways for novel modalities originating within the FSP ecosystem. Act as CMC strategic advisor, as needed
• Serves as an ambassador of PM for external stakeholders and industry as a whole

Requirements:

• PhD in a relevant scientific discipline with 15+ years of progressive CMC experience (MS with 18+ or BS with 20+ considered); Minimum 5 years in senior leadership with direct accountability for CMC strategy across multiple simultaneous programs
• Deep hands-on expertise in small molecules and biologics. Expertise is preferred (but not required) in advanced modalities incl. nucleic acids, cell or gene therapies
• Demonstrated track record of filing and defending regulatory dossiers (INDs, CTAs, BLAs/NDAs, or MAAs) across multiple programs and modalities; Current working knowledge of global regulatory expectations (FDA, EMA, PMDA) and direct experience in agency interactions on CMC topics.
• Proven ability of owning CMC strategy and execution across a multi-program portfolio simultaneously, including developing and managing CMC budgets, risk management, and delivery against aggressive timelines
• Extensive experience identifying, selecting, contracting, and managing CDMOs and CROs with specialized emerging modality capabilities, including leading technology transfer and resolving technical challenges at external sites
• Thought leadership in innovation, including novel delivery, high-throughput process development, and platform-based approaches to elevate program / portfolio value
• Strong understanding of AI/ML, digital process development tools, and data-driven manufacturing platforms to improve development speed and efficiency
• Executive presence and demonstrated ability to influence and align cross-functional PM and platform company leaders; Strong communicator who can translate complex CMC strategy and risk for non-specialist audiences
• Experience partnering with GxP Quality to establish quality systems appropriate for a development-stage organization, including SOPs, change control, and deviation management in a GxP environment
• Entrepreneurial builder energized by creating structure in ambiguous, fast-moving environments; high accountability orientation with a bias for action and the ability to make sound decisions with incomplete information
• Collaborative, low-ego leadership style with genuine investment in team development and cross-functional relationships

About Flagship 

Flagship Pioneering is a scientific innovation engine that invents and builds companies that change the world. We bring together the greatest scientific minds with entrepreneurial company builders and assemble the capital to allow them to take courageous leaps in human health, sustainability, and beyond. 
 
What sets Flagship apart is our ability to advance biotechnology by uniting life science innovation, company creation, and capital investment under one roof in a way that is largely without precedent. Our team of scientists, entrepreneurial leaders, and professional capital managers are each aligned around an institutionalized process that enables us to innovate and create breakthroughs for the benefit of people and planet. 
 
 Many of the companies Flagship has founded have addressed humanity’s most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture. Flagship has been recognized twice on FORTUNE’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies, and has been named four times to Fast Company’s annual list of the World’s Most Innovative Companies. 

At Flagship, we recognize there is no perfect candidate. If you have some of the experience listed above but not all, please apply anyway. Experience comes in many forms, skills are transferable, and passion goes a long way. We are dedicated to building diverse and inclusive teams and look forward to learning more about your unique background.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto. 

The salary range for this role is $228,000 - $313,500. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Pioneering Medicines currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Pioneering Medicines's good faith estimate as of the date of publication and may be modified in the future.

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to translate novel ideas into clinical and commercial product. As the Senior Director, Late-Stage Cell Therapy Process Development, you will report to the Head of Process and Analytical Development and provide strategic, technical leadership for late stage process development of a PSC-derived islet product for Type 1 diabetes. You will build and manage a high performing process development team to develop commercial ready manufacturing processes. You will play a critical role in advancing our pipeline through pivotal process development, technology transfer, process characterization, and commercial readiness, ensuring robust, scalable, and compliant manufacturing processes. Cool Stuff!  This role will require onsite leadership in Cambridge, MA.

What you’ll do

• Partner closely with Research to develop 3D stem cell seed train and differentiation processes, including integration of bioreactors and automated and closed technologies and drug product (DP) process-enabling studies including formulation, fill/finish, and cryopreservation.
• Lead late stage process development for PSC-derived products, ensuring scalability, robustness, quality and regulatory compliance.
• Lead process characterization and validation activities, leveraging design of experiments (DoE) and Quality by Design (QbD) approaches and support process performance qualification (PPQ).
• Establish and execute a comparability strategy for pivotal process changes.
• Enable technology transfer to CDMOs or internal manufacturing, providing technical input and ensuring successful implementation.
• Author and review CMC sections of regulatory submissions (e.g., IND, BLA) and support regulatory Q&A and inspections.
• Collaborate and influence partners across multidisciplinary teams (e.g. Research, Analytical Development, Quality, Regulatory, Manufacturing, Clinical and Supply Chain) to execute on CMC deliverables for pivotal and commercial.
• Hire, mentor and develop a team of engineers, fostering a culture of trust, curiosity, scientific rigor, collaboration, and continuous improvement across a fast-paced performance driven environment.
• Contribute to developing the organization strategy, cultivate opportunities for innovation and career development, champion the Sana culture and make it a great place to work.

What we’re looking for

• Ph.D. in Biochemical Engineering, Chemical Engineering, or related discipline with a minimum of 10 years experience in cell therapy process development (including >5 years late stage development), with at least 5 years in a leadership role.
• Hands-on experience with perfusion and single use bioreactor systems at various scales from benchtop to pilot/production scale and technologies that enable closed and automated cell therapy manufacturing.
• Knowledge of stem cell biology and 2D/3D stem cell expansion and differentiation, including raw material selection for GMP manufacturing.
• In depth knowledge and experience with application of engineering principles, DoE and QbD approaches to enable bioreactor scale up and scale down model development.
• Experience with risk and root cause analysis and tools (e.g. FMEA, Ishikawa).
• Knowledge of cGMP, and quality and regulatory expectations for commercial cell therapy and/or biologics products.
• Experience supporting regulatory submissions, Q&A and audits/inspections.
• Experience supporting tech transfer of a cell therapy process to manufacturing.
• Strong influencing skills and ability to work in a matrixed, fast paced environment with evolving roles and responsibilities.
• Excellent written and verbal communication skills with ability to effectively communicate and partner with all levels of the organization.

What will separate you from the crowd

• > 10 years direct experience developing cell therapy processes from pre pivotal to commercial.
• Experience with optimizing protocols to generate stem cell derived islets
• Experience with PSC differentiation at >10 L in bioreactors
• Knowledge of media development including analytical tools to evaluate spent media and regulatory expectations for raw materials.
• Knowledge of process analytical technology (PAT) and analytical methods for deep characterization of stem cell derived products
• Strong track record of identifying and implementing novel cell therapy manufacturing technologies into GMP.

What you should know

• The base pay range for this position at commencement of employment is expected to be between $250,000 and $300,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

Company description

Serif Biomedicine is a privately held, early-stage biotechnology company developing a novel approach to gene therapy that can address currently untreatable diseases. It was founded by Flagship Pioneering, an innovation enterprise that conceives, creates, resources, and grows first-in-category life sciences companies.

Flagship Pioneering has created over 100 groundbreaking companies over the past twenty years, all of which are pioneering novel and proprietary biological, industrial, and engineering approaches to solve major needs in human health and sustainability. These companies include Moderna (MRNA), Syros Pharmaceuticals (SYRS), Seres Therapeutics (NASDAQ:MCRB), Generate Biomedicines, Tessera Tx, Evelo Biosciences (EVLO), and Indigo Agriculture.

The role

We are seeking a highly experienced Lipid Nanoparticle (LNP) Formulation Senior Scientist to lead the design, execution, and interpretation of advanced Design of Experiments (DOE) strategies to drive innovation in next-generation LNP formulations. This role will play a central role in shaping formulation and delivery strategies for nucleic acid therapeutics within a dynamic and collaborative research environment.

The successful candidate will not only develop, optimize, and characterize LNP systems, but also lead the design and establishment of a high-throughput LNP screening platform spanning in vitro systems and small and large animal models. This includes defining experimental frameworks, selecting and implementing appropriate assays, and building scalable workflows to accelerate candidate evaluation and selection.

As a senior scientific contributor, this individual will be expected to operate with a high degree of independence, influence cross-functional program direction, and identify innovative solutions to advance platform capabilities. The role also includes mentoring junior scientists and contributing to the broader scientific strategy through internal leadership and external scientific engagement.

Key responsibilities

• Drive the development, optimization, and implementation of a high-throughput LNP screening platform across small and large animal models, including experimental design, assay selection, and data analysis pipelines.
• Independently define scientific strategies and experimental roadmaps aligned with program goals.
• Serve as a scientific lead for one or more programs, influencing cross-functional decisions across biology, formulation, and translational teams.
• Identify technical gaps and proactively propose innovative solutions to improve platform capabilities and throughput.
• Mentor junior scientists and contribute to building a strong, collaborative scientific culture.
• Communicate findings clearly to internal stakeholders and external partners; contribute to publications, patents, and regulatory documentation.
• Stay at the forefront of LNP delivery technologies and emerging screening methodologies, integrating new approaches where appropriate.

Professional experience and qualifications

• PhD or MS in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Materials Science, or a related field and 5+ years of industry experience 
• Proven track record of independently leading research projects and delivering impactful results.
• Demonstrated experience in nanoparticle/LNP design, screening, and in vivo evaluation, preferably including large animal models.
• Experience in developing or scaling high-throughput screening platforms is strongly preferred.
• Strong understanding of experimental design, statistics, and data interpretation.
• Evidence of scientific leadership (e.g., mentoring, leading collaborations, publications, patents).
• Excellent communication and cross-functional collaboration skills.
• Strong hands-on experience with LNP formulations, including formulation development and optimization

What We Offer

• Opportunity to work at the forefront of LNP formulation innovation
• Collaborative, science-driven culture with high impact research
• Competitive compensation and benefits package

ABOUT FLAGSHIP PIONEERING

Flagship Pioneering invents and builds platform companies, each with the potential for multiple products that transform human health, sustainability and beyond. Since its launch in 2000, Flagship has originated more than 100 companies. Many of these companies have addressed humanity most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture.

Flagship has been recognized twice on FORTUNE Change the World list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies and has been twice named to Fast Company annual list of the World Most Innovative Companies. Learn more about Flagship https://url.us.m.mimecastprotect.com/s/xLXBCqxk3LTk9pwcZf3CEkjif?domain=flagshippioneering.com.

At Flagship, we accept impossible missions to enable bigger leaps. Our core values guide us through uncertainty and toward lasting impact.

We are an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.

The salary range for this role is $126,000 - $181,500. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. FL87 currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on FL87's good faith estimate as of the date of publication and may be modified in the future.

Company description

Serif Biomedicines is a privately held, early-stage biotechnology company developing a novel approach to gene therapy that can address currently untreatable diseases. It was founded by Flagship Pioneering, an innovation enterprise that conceives, creates, resources, and grows first-in-category life sciences companies.

Flagship Pioneering has created over 100 groundbreaking companies over the past twenty years, all of which are pioneering novel and proprietary biological, industrial, and engineering approaches to solve major needs in human health and sustainability. These companies include Moderna (MRNA), Syros Pharmaceuticals (SYRS), Seres Therapeutics (NASDAQ:MCRB), Generate Biomedicines, Tessera Tx, Evelo Biosciences (EVLO), and Indigo Agriculture.

The role

We are seeking a motivated Associate Scientist to support the development, preparation, and characterization of Lipid Nanoparticle (LNP) formulations. This role is highly hands-on and focused on formulating, screening, and analyzing LNPs to support discovery and development programs. The ideal candidate works well in a fast-paced, team-oriented environment and is eager to deepen their expertise in formulation science.

Key responsibilities

• Prepare and formulate LNPs using established protocols and evolving methods
• Execute formulation experiments to support optimization and screening efforts
• Perform LNP characterization and analytics, including particle size, PDI, encapsulation efficiency, and stability testing
• Accurately document experimental procedures, results, and observations in laboratory records
• Analyze and summarize experimental data and communicate findings to project teams
• Collaborate closely with scientists across formulation, analytics, and biology functions
• Support routine laboratory operations, including reagent preparation, equipment upkeep, and inventory management

Professional experience and qualifications

• BS or MS in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related field and 8+ years of industry experience
• Hands-on experience with LNP formulations or lipid-based delivery systems
• Familiarity with LNP analytical techniques (e.g., DLS, encapsulation assays, basic stability studies)
• Strong attention to detail and ability to follow experimental protocols
• Ability to work effectively as part of a team in a fast-paced environment
• Good written and verbal communication skills

What We Offer

• Opportunity to work at the forefront of LNP formulation innovation
• Collaborative, science-driven culture with high impact research
• Competitive compensation and benefits package

LOCATION: Cambridge, MA

ABOUT FLAGSHIP PIONEERING

Flagship Pioneering invents and builds platform companies, each with the potential for multiple products that transform human health, sustainability and beyond. Since its launch in 2000, Flagship has originated more than 100 companies. Many of these companies have addressed humanity most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture.

Flagship has been recognized twice on FORTUNE Change the World list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies and has been twice named to Fast Company annual list of the World Most Innovative Companies. Learn more about Flagship https://url.us.m.mimecastprotect.com/s/xLXBCqxk3LTk9pwcZf3CEkjif?domain=flagshippioneering.com.

At Flagship, we accept impossible missions to enable bigger leaps. Our core values guide us through uncertainty and toward lasting impact.

We are an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.

The salary range for this role is $96,000 - $126,500. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Serif Biomedicines currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Serif Biomedicine's good faith estimate as of the date of publication and may be modified in the future.

Company Description

Metaphore Biotechnologies, Inc. is a privately held biotechnology company building the next generation of biological therapeutics. Inspired by nature, our mission is to transform patient lives by unlocking the power of biological therapeutics with a new mimic-discovery platform. 

Role Summary 

Metaphore is seeking a Senior Director, CMC Development & External Manufacturing to lead end-to-end CMC strategy and execution for our biologics programs. This individual will have primary accountability for developing fit-for-stage drug substance and drug product processes with external manufacturing CDMOs. This leader will own the integrated CMC plan (strategy, timeline, budget, and risks), partner with key internal stakeholders to enable seamless transition into late stage CMC work and ensure CMC deliverables support regulatory submissions and clinical supply needs.  

Key Responsibilities 

• Own end-to-end CMC strategy and execution, including governance, integrated plans (timeline/resources/interdependencies), scenario planning, supply forecasting, and risk management to deliver program and company milestones.  
• Lead external CDMO strategy and oversight for drug substance and drug product (scope setting, operating cadence, deliverables/action tracking, issue escalation/resolution), ensuring execution success.  
• Provide technical leadership across upstream/downstream, analytical, formulation, fill/finish, and stability, guiding fit-for-stage development decisions (e.g., scale-up strategy, formulation/container strategy, stability approach) and tech transfer readiness.  
• Ensure phase-appropriate GMP readiness and campaign execution at the CDMO, including deviation/change/CAPA alignment with Quality and ensuring testing and disposition timelines support clinical needs.  
• Drive CMC regulatory deliverables (CMC sections of submissions/amendments) and executive-level communication of status, decisions, risks, and mitigation plans; build/lead high-performing internal and matrixed teams.  

Required Qualifications 

• Advanced degree (PhD preferred; MS with significant experience considered) in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related discipline. 15+ years of biologics CMC experience spanning development through GMP manufacturing and external manufacturing oversight (drug substance and/or drug product). 
• Proven ability to define CMC strategy and translate it into cross-functional deliverables, integrated plans, timelines, and budgets, with strong program leadership and operating rigor.  
• Demonstrated success managing external collaborations/CDMOs to deliver CMC development and manufacturing outcomes in fast-paced, matrixed environments.  
• Strong technical breadth in at least one major CMC area (and ability to lead across all), including upstream/downstream, analytics, and/or fill/finish/drug product with stability/tech transfer exposure.  
• Deep working knowledge of cGMP/GxP and quality systems, with clear, concise communication and stakeholder influence skills.  

Desired Skills 

• Define and execute strategic vision to advance scientific innovation, translating emerging insights into high-impact initiatives, roadmaps, and measurable outcomes. 
• Act decisively and own end-to-end accountability, making timely, data-informed decisions, taking responsibility for results, and delivering against commitments in dynamic environments. 
• Build change-agile, high-performing teams and networks, growing others through coaching and development, modeling strong self-awareness, and cultivating relationships with external thought leaders to accelerate learning and partnerships. 

About Flagship Pioneering

Flagship Pioneering invents and builds platform companies, each with the potential for multiple products that transform human health, sustainability and beyond. Since its launch in 2000, Flagship has originated more than 100 companies. Many of these companies have addressed humanity’s most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture.  

Flagship has been recognized twice on FORTUNE’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies and has been twice named to Fast Company’s annual list of the World’s Most Innovative Companies. Learn more about Flagship at www.flagshippioneering.com.

At Flagship, we accept impossible missions to enable bigger leaps. Our core values guide us through uncertainty and toward lasting impact.

We are an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

We recognize that great candidates often bring unique strengths without fulfilling every qualification. If you have some of the experience listed above but not all, please apply anyway. We are dedicated to building diverse and inclusive teams and look forward to learning more about your background and interest in Flagship.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.

The salary range for this role is $213,000 - $280,500. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Metaphore Biotechnologies, Inc. currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Metaphore Biotechnologies, Inc.'s good faith estimate as of the date of publication and may be modified in the future.

COMPANY DESCRIPTION

Flagship Pioneering is a bioplatform innovation company that invents and builds companies that change the world. We bring together the greatest scientific minds with entrepreneurial company builders and assemble the capital to allow them to take courageous leaps. Those big leaps in human health, sustainability and beyond exponentially accelerate scientific progress in areas ranging from disease detection and treatment and nature-positive agriculture to novel applications of AI that are driving the creation of new technologies.   

What sets Flagship apart is our ability to advance science and technology by uniting innovation, company creation, and capital investment under one roof in a way that is largely without precedent. Our scientific founders, entrepreneurial leaders, and professional capital managers are each aligned around an institutionalized process that enables us to innovate and transform for the benefit of people and planet.   

Many of the companies Flagship has founded have addressed humanity’s most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture.  

Flagship has been recognized twice on FORTUNE’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies, and has been twice named to Fast Company’s annual list of the World’s Most Innovative Companies. 

THE ROLE

We are seeking a Senior Scientist to lead the design, characterization, and performance optimization of aerosolizable particle systems. This role will be responsible for developing a foundational understanding of how engineered particles behave during generation, dispersion, and transport in air, and translating that understanding into robust, scalable material and system designs.

The Senior Scientist will operate at the interface of materials science, aerosol physics, and experimental engineering — owning the development of aerosol testing capabilities, guiding experimental strategy, and linking particle design to airborne performance. This individual will play a critical role in shaping early technical direction, establishing core methodologies, and driving progress from concept through validation.

This is a highly cross-functional role, working closely with formulation, process development, and hardware teams to ensure tight integration between particle design, production methods, and real-world deployment constraints.

KEY RESPONSIBILITIES

• Lead the design and optimization of particle systems for aerosolization, with ownership over key parameters including size distribution, morphology, density, and dispersibility;
• Develop and scale experimental capabilities for aerosol generation and testing, including selection, design, and validation of dispersal systems and measurement tools;
• Define and execute experimental strategies to understand relationships between particle properties, environmental conditions, and airborne behavior;
• Characterize aerosol performance using appropriate instrumentation (e.g., particle sizers, optical counters, flow diagnostics), and translate findings into design rules and system improvements;
• Develop and apply computational approaches to model aerosol physics and particle dispersal, integrating atmospheric transport and dispersion models or Lagrangian particle simulations with experimental data to inform particle and system design;
• Collaborate cross-functionally with formulation and process development teams to align particle production methods with aerosol performance requirements;
• Establish best practices, workflows, and technical standards for aerosol experimentation, including calibration, reproducibility, and data quality;
• Interpret complex datasets and communicate insights clearly to guide technical and strategic decision-making;
• Contribute to system-level thinking around particle generation, dispersion, and scale-up, incorporating constraints from real-world operating environments;
• Mentor junior scientists and contribute to building a strong experimental and technical culture within the team.

PROFESSIONAL EXPERIENCE & QUALIFICATIONS 

• PhD in aerosol science, chemical engineering, mechanical engineering, physics, materials science, or a related discipline, with 5+ years of relevant industry or applied research experience (or Master’s/Bachelor’s with significant additional experience);
• Deep expertise in aerosol science, including particle generation, transport, and measurement, with a strong understanding of how particle properties influence airborne behavior;
• Hands-on experience with aerosol instrumentation (e.g., SMPS, APS, optical particle counters) and the ability to design and interpret complex experiments;
• Strong foundation in transport phenomena, fluid dynamics, and particle physics as applied to airborne systems;
• Experience working with particulate materials, including connecting physical properties (size, shape, density, surface characteristics) to performance outcomes;
• Experience with modeling aerosol transport and dispersion using Lagrangian particle dispersion models, computational fluid dynamics (CFD) simulations, or related numerical approaches is a strong plus;
• Demonstrated ability to design experimental systems and build or adapt setups for aerosol generation and testing;
• Proven ability to lead technical projects in fast-paced, early-stage environments, balancing hands-on work with strategic thinking;
• Strong communication and documentation skills, with the ability to synthesize complex technical findings into clear, decision-relevant insights;
• Demonstrated curiosity, adaptability, and comfort working across disciplines to translate early-stage scientific ideas into functional systems.

LOCATION:  Cambridge, MA

ABOUT FLAGSHIP PIONEERING:

Flagship Pioneering invents and builds platform companies, each with the potential for multiple products that transform human health, sustainability and beyond. Since its launch in 2000, Flagship has originated more than 100 companies. Many of these companies have addressed humanity’s most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture.  

Flagship has been recognized twice on FORTUNE’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies and has been twice named to Fast Company’s annual list of the World’s Most Innovative Companies. Learn more about Flagship at www.flagshippioneering.com.

At Flagship, we accept impossible missions to enable bigger leaps. Our core values guide us through uncertainty and toward lasting impact.

We are an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

We recognize that great candidates often bring unique strengths without fulfilling every qualification. If you have some of the experience listed above but not all, please apply anyway. We are dedicated to building diverse and inclusive teams and look forward to learning more about your background and interest in Flagship.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.

#LI-TL1

The salary range for this role is $126,000 - $159,500. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Protocos currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Protocos's good faith estimate as of the date of publication and may be modified in the future.

Company Overview 

Fulcrum Therapeutics, Inc. (“Fulcrum”) [NASDAQ: FULC] is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases. Fulcrum is deeply committed to bringing hope and new options to patients suffering from rare hematologic disorders and is developing a pipeline of clinical and preclinical assets. Fulcrum’s lead clinical asset is pociredir, a first-in-class small molecule designed to increase the expression of fetal hemoglobin for the treatment of sickle cell disease and other hemoglobinopathies. We are working to expand our portfolio of clinical-stage assets and seek a driven and strategic leader to head our Pharmaceutical Development function.

Description

Reporting to the Head of Technical Operations, the Director of Pharmaceutical Development will lead all drug product development activities including technical, managerial, and budgetary aspects. This includes formulation development, manufacture of clinical trial material, process optimization, scale-up, and validation. The successful candidate will lead, plan and manage the technical and business-related activities associated with drug product development and manufacturing at contract development and manufacturing vendors for all dosage form programs.

Key Responsibilities

• Lead all strategic and tactical aspects of drug product development at Fulcrum
• Design and execute pharmaceutical product development plans for all development programs in accordance with corporate goals
• Collaborate with colleagues in Drug Substance, Analytical, ClinOps, QA, and Reg CMC to ensure plans are cross-functional, phase-appropriate, and on time
• Lead pharmaceutical development for the pociredir program, including CTM for pivotal clinical studies, pre-validation studies, validation plans, and commercial launch supply
• Lead and manage product development, technology transfer, and clinical manufacturing activities at contract manufacturing organizations (CMOs), assuring compliance with Regulatory and Quality requirements
• Lead pediatric formulation development efforts, as required
• Review and approve a broad spectrum of documents (MBRs, Specifications, Protocols, Reports, etc.) at CMOs
• Generate, review and approve documents related to Drug Product (formulation, process development, manufacturing, etc.) for Regulatory submissions (IND/IMPD and NDA/MAA)

Qualifications

• D with 10 years or MS with equivalent years of experience. Professional background in Pharmaceutical Sciences (preferred) or Chemical Engineering
• Proven track record and leadership in phase-appropriate drug development through pivotal studies (required) and approval (preferred)
• SME in material science aspects of dosage forms and drug delivery, with emphasis on solid oral dosage forms; strong knowledge in Dissolution, Biopharmaceutics and PK
• Well versed in Regulatory CMC and ICH guidance, including exposure to FDA interactions (e.g. via EOP2 or preNDA meetings)
• Strong written and oral communication skills; highly effective collaborator with “customers” in ClinOps and Commercial
• Ability to hire and recruit staff, including key contractors and consultants
• Positive work presence; responds to stress and ambiguity with humor

Company Overview 

Fulcrum Therapeutics, Inc. (“Fulcrum”) [NASDAQ: FULC] is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases. Fulcrum is deeply committed to bringing hope and new options to patients suffering from rare hematologic disorders and is developing a pipeline of clinical and preclinical assets. Fulcrum’s lead clinical asset is pociredir, a first-in-class small molecule designed to increase the expression of fetal hemoglobin for the treatment of sickle cell disease and other hemoglobinopathies. We are working to expand our portfolio of clinical-stage assets and seek a driven and strategic leader to head our Analytical Chemistry function.

Description

Reporting to the Head of Technical Operations, the Director of Analytical Chemistry is responsible for the design and execution of the control strategies for the manufacture of drug substances and drug products for Fulcrum developmental programs.  In this position, the successful candidate will provide technical oversight of all Quality Control (QC) activities at DS and DP contract manufacturers. Additional responsibilities include collaborating with pharmaceutics on pre-formulation activities, collaborating with QA on OOS and OOT investigations and CMC risk management, and helping Reg-CMC author relevant sections of regulatory filings.

Key Responsibilities

• Provide technical leadership to CMOs and CROs for drug substance and drug product process development, including cGMP method development, validation, method transfer, method remediation, data analysis and reporting to ensure compliance with GCP, GLP and cGMP standards
• Collaborate with colleagues in Drug Substance, Drug Product, QA, and Reg CMC to ensure plans are cross-functional, phase-appropriate, and on time
• Responsible for design and management of stability studies, including shelf-life and retest date management, to ensure seamless clinical supply
• Lead and manage reference standard, in-process control, and specification strategies across the pipeline
• Review and approve a broad spectrum of documents (Test Methods, Qualification / Validation Protocols, Specifications, Reports, etc.) at CMOs
• Generate, review and approve documents related to the control of DS and DP for Regulatory submissions (IND/IMPD and NDA/MAA)
• Visit contract manufacturing sites both domestically and internationally to support key production milestones and build excellent business relationships

Qualifications

• MS with 15+ or PhD with 10+ years of relevant experience in the development and application of analytical control strategies for both drug substance and drug product
• Expert in the development of test methods that employ advanced analytical techniques for Quality Control (UPLC, GC, MS, PSD, etc.)
• Proficient at troubleshooting analytical methods at CMOs
• Proven track record and leadership in phase-appropriate analytical control strategies from early development through pivotal studies
• Well versed in Regulatory CMC and ICH guidance
• Highly effective collaborator with “customers” in DS and DP, QA and RA
• Positive work presence; responds to stress and ambiguity with humor

About the Role:

Stylus Medicine is seeking an intellectually curious and collaborative Senior Scientist, who will lead the development of upstream microbial fermentation processes as part of our CMC Tech Ops team. This role will be responsible for process definition, development, characterization, scale-up and tech transfer from bench scale to pilot. Working closely with the Research, Preclinical, and Formulation teams, this is a special opportunity to advance the development of transformative in vivo genetic medicines.

Key Responsibilities & Accountabilities:

• Develop scalable production processes for nucleic acids and recombinant proteins
• Leverage expertise in fermentation and mammalian cell culture to design, optimize, scale-up and characterize production processes
• Independently utilize multivariate design of experiment (DoE) approaches to improve productivity and optimize parameters for product quality
• Drive fermentation platform development and new technology implementation to improve process performance, generation of predictive process models, and enhance process control and robustness
• Design and implement in-process analytics to improve productivity while reducing process and product derived impurities
• Maintain and troubleshoot equipment to ensure consistency and continuity of operations
• Document, analyze and present experimental results internally and externally
• Partner with CDMOs and provide technology transfer support to facilitate scale up
• Interface with cross-functional teams to ensure programs are on track and stakeholders’ needs are met
• Maintain accurate and reliable record keeping including database management, batch records, notebooks, and all other pertinent documentation

Qualifications & Skills:

• PhD in Chemical/Biomedical Engineering, Biochemistry, Pharmaceutical Sciences, or related discipline with >4 years of experience, or BS/MS with >8 years of experience in biopharmaceutical or biotechnology development, including experience in developing scalable fermentation processes for producing plasmid DNA and/or recombinant products
• In-depth experience and knowledge in fermentation process development, optimization, and process scale-up / scale-down model development
• Familiarity with strain engineering and biocatalysis
• Familiarity with performing operations in a cleanroom environment, applying controls to ensure aseptic processing
• Demonstrated ability to coach and mentor junior researchers
• Independently motivated and good problem-solving ability
• Attention to detail and accuracy in developing, reviewing, and following protocols, SOPs, batch records and technology transfer documents is a must
• Demonstrated ability to work collaboratively across teams to meet project deliverables and timelines
• Strong communication, decision-making and organizational skills
• Proficiency with statistical analysis software (e.g., JMP) is highly desired
• Prior experience partnering with external CDMOs and conducting tech transfers preferred

Pay Range: $155,000 - $170,000

The Role:

Reporting to the Associate Director, Formulation Sciences, the Senior Manager, Formulation Sciences will act as late-stage drug product subject matter expert and will support drug product process validation toward commercialization. The successful candidate needs to demonstrate a proven record of working in a virtual environment with CDMOs to deliver clinical and commercial supplies in support of fast-paced late-stage development programs. Using strategic thinking, the Senior Manager must be able to develop and execute process validation strategies for successful product commercialization.

This individual has responsibility for support of drug product process validation, scale up, and post-approval changes (SUPAC) and routine commercial manufacturing activities across Nuvalent’s contract research and manufacturing organizations. The primary accountability is being the steward for product development and manufacturing as these programs transition through development and into commercialization. The ultimate goal will be to ensure robust process and manufacture strategies for consistent commercial supply.

Responsibilities:

• Support drug product Process Validation activities, Scale up and post-approval changes (SUPAC) and routine commercial manufacturing at CDMOs.
• Identify critical process parameters based on the risk assessment and understanding the impact of material attributes and process parameters on critical quality attributes. Implement appropriate process controls to ensure delivery of consistent batch product quality.
• Draft, coordinate, execute validation protocols, perform data analysis, author/review and approve process validation reports with consistent and effective communication with other functions.
• Provide support to routine process validation studies, assisting with product technology transfers or lifecycle management changes such as process improvement, addition of secondary API and manufacture site change etc.
• Perform technical review of drug product manufacture deviations, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), perform activities for drug product lot release (assess deviations and process changes).
• Work closely with other team members and cross-functionally with quality assurance, analytical/QC, chemical development, supply chain, and project management team to achieve all project deliverables.
• Provide support for technical decision-making regarding cGMP compliance, validation strategy and regulatory pathway for SUPAC changes etc.
• Familiar with statistical analysis software, such as JMP.
• Perform process capability analysis, identify risk, and make recommendations for process improvement.
• Manage documentation, change controls, material inventory, product complaints, and deviation resolution at CDMOs.
• Represent the drug product group as a Subject Matter Expert to support audits and regulatory inspections.

• Support authoring the relevant technical sections of regulatory filings.

• Support late-stage validation and post-approval readiness activities and commercial manufacture activities within a virtual working environment.

Competencies:

• Strong organizational, planning, and multitasking skills in a fast‑paced environment.
• Excellent relationship‑building and communication skills across diverse teams.
• Evidence of effective cross‑functional collaboration with both internal teams and external partners.
• Strong problem‑solving and analytical skills with the ability to break down complex issues.
• Results‑driven mindset with attention to quality and timelines. A strong understanding and knowledge of cGMP/ICH regulations and an ability to apply them to drug product development and manufacturing is required.
• Excellent organization and multi-tasking skills.
• Experience building positive and effective cross functional relationships and the ability to align stakeholders, both internally and externally to Nuvalent.

 Qualifications:

• PhD in pharmaceutics, pharmaceutical sciences, chemical engineering or related field with a minimum of 3+ years or MS with 6+ years /BS with 10+ years of industry experience.
• Proven track record on drug product process validation, scale up and manufacture for solid dosage form (tablets).
• Experience with QbD principles and DOE methodology preferred.
• Manage the outsourcing manufacturing activities at CDMO sites to meet CMC goals.
• Understanding of cGMP/ICH guidelines and the ability to apply them to development and manufacturing.

• Experience with solid dosage form (tablet) process development; exposure to late-stage validation is a plus.

• Ability to author and critically review relevant development reports as well as regulatory dossiers.
• Up to 25% travel is expected, both domestically and internationally.

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

About Sail:

Sail Biomedicines is pioneering the integrative design and deployment of fully programmable medicines to transform patient care. Sail’s platform combines first-in-class programmable circular RNA technology (Endless RNA™ or eRNA), and an industry-leading platform of programmable nanoparticles, utilizing natural components, to unlock comprehensive programming of medicines for the first time. By leveraging cutting-edge eRNA and nanoparticle deployment technology, Sail is also making unparalleled use of AI techniques to identify and design fully programmable medicines that are potent, targeted, versatile, and tunable. Sail was founded by Flagship Pioneering.

The Role:

Sail Biomedicines is seeking a Research Associate II to join our Preclinical Manufacturing team, supporting the production of RNA and lipid nanoparticle (LNP) drug substances and drug products. As part of the Technical Operations group, you will contribute directly to the development and delivery of preclinical materials for both internal and partnered programs.

Thisis a hands-on, lab-based role requiring strong experimental execution, attention to detail, and cross-functional collaboration. You will play a key role in advancing scalable RNA and LNP manufacturing processes to enable pipeline progress.

Responsibilities:

• Support the production of RNA cargo molecules and lipid nanoparticle (LNP) formulations for preclinical studies
• Execute hands-on laboratory work involving eRNA synthesis, purification, and LNP encapsulation
• Contribute to the development, optimization, and scale-up of high-yield, high-quality RNA/LNP processes
• Operate and maintain lab-scale instrumentation, including AKTA (FPLC), TFF systems, PCR, HPLC, capillary electrophoresis, UV-Vis, and light scattering platforms
• Perform analytical characterization and quantification of RNA and other nucleic acids
• Analyze experimental data and document results in electronic lab notebooks (ELN) and technical reports
• Collaborate cross-functionally with research, analytical, and process development teams to support project goals

Required Qualifications:

• B.S. with 2+ years of industry experience or M.S. in Molecular Biology, Biochemistry, Biochemical Engineering, or a related field
• Hands-on experience in one or more of the following areas:
  • RNA/DNA production and purification
  • LNP formulation and characterization
  • Chromatography (e.g., AKTA/FPLC, HPLC)
  • Tangential flow filtration (TFF)
  • Automated liquid handling systems
• Strong understanding of experimental design, data analysis, and technical documentation
• Proficiency in core laboratory techniques, including aseptic technique, buffer preparation, and instrument operation/programming
• Experience with analytical methods such as capillary electrophoresis, UV-Vis, or light scattering is preferred

Preferred Qualifications:

• Detail-oriented with strong organizational and documentation skills
• Curious, proactive, and comfortable working both independently and in collaborative environments
• Effective communicator with the ability to clearly present technical data and insights

Salary Range: $75,000 - $100,000

Sail Biomedicines is an Equal Opportunity Employer. Sail does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, national origin, veteran status, or any other status protected under federal, state, or local law.

Position Overview:

Beam is seeking a scientist with expertise in formulation and ligand conjugation. The candidate will work on formulation, ligand conjugation, and scale-up of lipid nanoparticles (LNPs) targeting different organs and cell types. They will work as part of a team to develop drug products with the goal of bringing in vivo base editing to patients.

We are looking for an ambitious candidate who wants to grow within the LNP Sciences group. This candidate will help shape the LNP platform and grow with the aspirations of the organization as we advance into later stages of development.  

Primary Responsibilities:

• Responsible for formulation design, development, characterization, and technology transfer to enable development of Beam sterile drug products.
• Accountable as an individual contributor to support formulation development as well as providing necessary guidance and support of drug product control strategy for drug candidates across all stages of development.
• Independently design, execute, analyze, and document experiments to optimize LNP potency, tolerability, biodistribution, and ligand conjugation.
• Design and execute experiments to enable a robust and reproducible process for manufacture of ligand conjugated LNPs at-scale. Interface closely with Analytical Development and Biotherapeutics teams to characterize different unit operations for the manufacturing of DP to understand process robustness.
• Provide support with tech transfer activities for manufacturing of drug products.
• Generate high quality documentation as per Beam SOPs and in support of regulatory filings.
• Communicate scientifically rigorous findings via verbal and written communications, and presentations both internally and externally.

Qualifications:

• PhD or MS in Pharmaceutical Sciences, Chemical Engineering, Bioengineering or related field with drug product and CMC development experience (PhD 4+ years or MS 12+ years).
• Deep understanding of sterile product development. Prior industry research experience, especially in nucleic acids and drug delivery, is required. Experience with development of antibody-drug conjugates and/or biologics is preferred.
• Knowledge of statistical techniques and concepts (regression, properties of distributions, statistical tests, and proper usage, etc.).
• Ability to adapt to increasing scope and complexity of work brought on by growth/change and help others manage through change.
• A successful candidate will have excellent computational, written, and verbal communication skills, strong organizational abilities, and an ability to work with a diverse group of scientists and engineers.
• Ability to work in a hybrid environment with sufficient on-site presence.