Director, Bioassay Development: Potency & CMC
$167k - $300.7kModerna Therapeutics
Moderna Therapeutics in Norwood, Massachusetts, is seeking a leader in bioassay development to drive strategy for late-stage programs. This role involves ensuring that cell-based assays meet clinical and commercial requirements while interpreting complex regulatory guidelines. The ideal candidate will have advanced degrees and extensive experience in bioassay development, with a strong focus on regulatory compliance and analytical methodologies. Pay ranges from $167,000 to $300,700 annually, with additional benefits. #J-18808-Ljbffr Moderna Therapeutics
$167k - $300.7k
...delivery of our medicines. In this role, you will lead bioassay development strategy for late‑stage programs within the Potency Assurance function, ensuring cell‑based assays... ...strategies. Provide strategic leadership for CMC bioassay development, supporting IND/BLA...SuggestedFull time$174.5k - $274.23k
...A leading biopharmaceutical company in Boston seeks a Director, Regulatory Site CMC to ensure efficient management of regulatory change control and post-approval activities. The ideal candidate will have 10+ years of experience in regulatory CMC, a strong understanding...Suggested$167k - $300.7k
...technology, with a diverse pipeline of development programs across various diseases.As an employee... ...operationalize Moderna’s centralized Bioassay Center of Excellence (CoE), a... ...our Norwood, MA Technology Center, the Director will lead daily bioassay operations while...SuggestedFull timeWorldwideFlexible hours$142.5k - $256.5k
The Role Moderna is seeking an Associate Director, Process Development to lead upstream/fermentation process development for E. coli-based production... ...-down, process characterization, technology transfer, and CMC support. The successful candidate will bring strong technical...SuggestedPermanent employment$142.5k - $256.5k
...The Role The Associate Director, Global Regulatory, CMC will be responsible for coordinating regulatory CMC activities for one or more products... ...generation of transformative medicines for patients. Development of regulatory strategy for the products in our portfolio...SuggestedPermanent employmentWork at officeWork from home$142.5k - $256.5k
...stability strategies across a diverse mRNA portfolio spanning development, clinical, and commercial products. You will operate as a cross... ...authority interactions. Experience operating within cross‑functional CMC team structures. Experience in statistical analysis, stability...Permanent employmentWorldwide$142.5k - $256.5k
Overview The Associate Director, Global Regulatory, CMC will coordinate regulatory CMC activities for one or more products through all stages of... ...in a fast, results-oriented environment to support the development of transformative medicines. Responsibilities Develop/implement...- A pioneering biotech company in Norwood, MA is seeking a Director to lead the Bioassay Center of Excellence. This role requires strong leadership and expertise in bioassay operations and automation. The successful candidate will oversee a team, manage complex assays, and...
- Moderna is seeking a Director of Bioassay CoE based in Norwood, MA. This role includes leading a high-performing operations team, overseeing bioassay execution, and implementing a GxP-ready infrastructure. The ideal candidate will possess substantial hands-on experience...
- Takeda is seeking a Director Regulatory Site CMC in Boston, MA, to lead regulatory change management activities and ensure compliance with global HA requirements. The ideal candidate has over 10 years of biopharmaceutical/device industry experience and a strong understanding...
$130.8k - $209.4k
...strategies across a diverse portfolio of mRNA programs spanning development, clinical, and commercial stages. You will act as a program-... ...-life assessment. Experience working in cross-functional CMC teams within a matrixed development or commercial environment....Permanent employmentFull timeWork at officeWorldwide$142.5k - $256.5k
Moderna Therapeutics in Norwood, Massachusetts, is seeking an Associate Director for Global Regulatory, CMC to coordinate regulatory activities for various products. This role involves developing global regulatory strategies, managing multiple projects in a fast-paced environment...- ...Director/Associate Director, Cell Therapy CMC & Manufacturing We are seeking a highly experienced and visionary leader of CMC & Manufacturing to lead our cell therapy development programs. The successful candidate will help lead CMC strategy, manage process development...
- Xenon Pharmaceuticals Inc. is seeking a Director/Senior Director, CMC, Drug Substance to manage the development and manufacturing of cGMP small molecule APIs. This role requires a PhD in Chemistry or a related field with 10+ years of experience in a pharmaceutical environment...
- Reporting to the Vice President, CMC and QA, this role is key to progressing client’s programs to clinical development. The successful candidate will be a hands‑on leader working cross‑functionally to support delivery of client’s goals for initiation and delivery of clinical...Contract work
- About the Role We are seeking a Director/Senior Director, CMC, Drug Substance to join our team. The Director/Senior Director will help manage and oversee the development and manufacturing of cGMP small molecule active pharmaceutical ingredients (APIs) for late‑stage clinical...Temporary workRemote workFlexible hours2 days per week
$177k - $278.08k
...life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory... ...and regulatory CMC requirements relevant to global drug development and post-market support. Who has a proven ability to understand...Minimum wageFull timeTemporary workLocal areaImmediate startRemote workWorldwide- CeDent in Boston is looking for a CMC leader to oversee clinical program development. The role involves managing CMC vendors and collaborating with teams to ensure high-quality production of drug substances. Ideal candidates have a strong scientific background, with 8-...
- ...Aktis’ proprietary pipeline. We are seeking an Associate Director of Corporate Development. The Associate Director will lead high-impact contract negotiations... ...skills. This role will work cross-functionally with R&D, CMC, G&A, and external legal counsel on a variety of...Contract work
$229.98k - $277.85k
...Director/Sr Director, Chemical Development Watertown, Massachusetts, United States Treeline Biosciences, a clinical-stage biotechnology company advancing... ...process chemist with significant experience in CMC development and commercialization of small molecules and...Fixed term contract- ...by world-renowned experts in clinical care and research, drug development, and cancer biology, and Convergent’s proprietary platform is licensed... ...by providing strategic and operational leadership for the CMC execution and lifecycle management radiopharmaceutical drug...Work at office2 days per week3 days per week
- ...North America Director Of Business Development Computershare is looking for a North America Director of Business Development to join our team in Employee Share Plans (ESP). The Employee Share Plans (ESP) business is organized into three client-facing regions (EMEA...Contract workTemporary workFlexible hours
$170k - $220k
...Associate Director, Regulatory CMC – Solid Biosciences Charlestown, MA HQ Solid Biosciences is a precision genetic medicine company focused... ..., manufacturing and controls is at the forefront of development of our programs and regulatory CMC provides a leadership role...Full timeTemporary workRemote workFlexible hours- ...to drive strategic outcomes within the CMC Operations organization. The Senior Manager... ...solutions. This role will report to the Director of CMC Operations. RESPONSIBILITIES... ...environment. In-depth knowledge in drug development and manufacturing processes for...Work at office
- ...Business Development Director North American Renewables Ready to help scale the future of clean energy? North American Renewables (NAR) is a fast-growing renewable energy EPC firm - and the sister company to Professional Electrical Contractors of CT (PEC). Officially...For contractorsLocal areaRemote workFlexible hours
- Associate Director/Director, Program Management (Drug Development) Part‑time hybrid role based in Boston, MA About HotSpot Therapeutics, Inc. At HotSpot Therapeutics... ...and execution across Research, DMPK/Toxicology, CMC, Regulatory, and Clinical, translating inputs into...Part timeImmediate start2 days per week
$274k - $353k
...join our growing team as SVP/VP, Technical Development Operations & Strategy . We're seeking an... ...and Collaboration with Regulatory CMC and Quality. Lead upstream, downstream... ...therapy/viral vectors or complex biologics; potency/viral safety analytics and chain-of-identity...Flexible hours$260k - $305k
...accommodation or an alternative application process. Sr. Director, Discovery & Translational Development Full-Time: FTE 40 hrs. / Full Benefits .25 Charlestown... ...spanning Clinical Development, Regulatory, CMC, Program Management, Business Development, and external...Full timeTemporary workFlexible hours- ...successful candidate will possess a strong understanding of business development and licensing and play a key role in driving strategic growth... ...due diligence and alliance management, coordinate with R&D, CMC, Clinical, Regulatory, Operations, and Finance and executive...Temporary work
- ...Grade: The position level varies from Director to Sr. Director, determined by the candidate... ...Executive Director or Above of Business Development ~ East Coast – Boston, MA Must... ...Biotech companies, familiarity with the CMC process, and general knowledge of API....
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