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  • Director Quality CMC Development

    3 weeks ago

    Boston, Massachusetts, United States Cpl Full time

    Director of Quality CMC Development - East Coast based remoteThis role offers the flexibility to work remotely from locations within the U.S/Canada, with a preference for Eastern Time Zone working hours to collaborate with EU teams.Travel is required.Position Overview:Cpl Life Sciences is looking for a Director of Quality CMC Development (Product...

  • VP, Chemistry, Manufacturing and Controls

    2 weeks ago

    Boston, United States Replimune Group Full time

    Overview The Vice President of CMC is responsible for the leadership and management of Replimune’s Manufacturing function at the Framingham site and the supporting global Process Development function. The role holder will oversee all aspects of drug substance and drug product development and scale up, technology transfer, clinical and commercial...

  • Associate Director, Regulatory Affairs CMC Writer

    1 month ago

    Boston, United States Pharvaris Full time

    Pharvaris is a Nasdaq listed late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients who suffer sudden and prolonged attacks of swelling in multiple...

  • Associate Director, Regulatory Affairs CMC Writer

    1 month ago

    Boston, United States Pharvaris Full time

    Pharvaris is a Nasdaq listed late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients who suffer sudden and prolonged attacks of swelling in multiple...

  • Manager to Sr. Manager, Regulatory CMC

    3 months ago

    Boston, United States PharmaLex Full time

    Job DescriptionJob DescriptionPharmaLex[RK1]  is one of the largest providers of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance, Epidemiology and Risk Management worldwide. Through our US, European and Asian offices, we provide integrated drug development services through a complete range of offerings...

  • Analytical CMC Strategy Associate Director

    2 days ago

    Boston, United States Vertex Pharmaceuticals Incorporated Full time

    Job DescriptionGeneral Summary:Vertex Pharmaceuticals is seeking a highly motivated, collaborative, and innovative Associate Director specializing in analytical CMC strategy to provide scientific leadership within and across functional areas. The Analytical CMC Strategy Associate Director is the primary analytical liaison for their program(s) and will lead,...

  • AD/Director, Business Development CMC

    1 month ago

    Boston, Massachusetts, United States Michael Page Full time

    Leverage scientific background to contribute to business growth and revenueJoin global CDMO/CRO generating over 1 billion in revenue annually About Our Client This client is a growing international full-service CDMO/CRO within the biotechnology space looking to aggressively expand its footprint in the US. The company has a strong base of API/Small Molecule,...

  • Head, Discovery Biologics

    2 months ago

    Boston, United States Fable Therapeutics Full time

    About Us: Fable Therapeutics (Fable) is a discovery-stage biotechnology company which develops purpose-built biologics designed to overcome therapeutic index limitations and channel therapeutic response where and when it matters.Fable is powered by state-of-the-art structure and sequence-based protein language models. Founded by leading ML scientists and...

  • Head, Discovery Biologics

    2 months ago

    Boston, United States Fable Therapeutics Full time

    About Us: Fable Therapeutics (Fable) is a discovery-stage biotechnology company which develops purpose-built biologics designed to overcome therapeutic index limitations and channel therapeutic response where and when it matters.Fable is powered by state-of-the-art structure and sequence-based protein language models. Founded by leading ML scientists and...

  • Scientist I/II, Analytical Development

    3 months ago

    Boston, United States PepGen Full time

    Job DescriptionJob DescriptionScientist I/II, Analytical DevelopmentPosition Summary The Scientist, Analytical Development/CMC will be a key member of the Analytical Development group at PepGen. The successful candidate will have great opportunities to use state-of art instruments for studying various potential drug candidates to ultimately create...

  • Director, Analytical Development – Oligonucleotides

    1 month ago

    Boston, United States Kennedy Bond Full time

    We are looking for an established Analytical Scientist to join the CMC Leadership team and head the entire Analytical function of an up-and-coming Biotech, focused on neurological diseases. Backed by a well-known Venture Capitalist firm, our client, who’s operating in stealth mode, will be entering in the clinic in the next 5-8 months. This role, reporting...

  • Senior Director/Executive Director CMC

    1 day ago

    Boston, United States AL Solutions Full time

    Job DescriptionJob DescriptionBuild and lead CMC teams dedicated to the development and optimization of protein biologics processes.Utilize your CMC expertise to steer the nomination of Development Candidates.Select and collaborate with CDMOs; craft contracts in partnership with Executive Leadership and Finance.Oversee the transfer and management of...

  • AD/Director, Business Development CMC

    1 month ago

    Boston, United States Michael Page Full time

    Leverage scientific background to contribute to business growth and revenueJoin global CDMO/CRO generating over 1 billion in revenue annually About Our Client This client is a growing international full-service CDMO/CRO within the biotechnology space looking to aggressively expand its footprint in the US. The company has a strong base of API/Small...

  • Head of Business Development

    2 weeks ago

    Boston, United States Berkner Group Full time

    Head of Business DevelopmentThe Company:Our client is a technology company based in Cambridge, MA, commercializing a breakthrough electrochemical process called Advanced Lithium Extraction (ALE). ALE uses renewable electricity to make lithium cheaply, safely, and with a lower carbon footprint. Moreover, ALE is more versatile than traditional extraction...

  • Manager, Global Regulatory Affairs CMC

    3 months ago

    Boston, Massachusetts, United States Takeda Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...

  • Director, Upstream Process Development

    3 weeks ago

    Boston, United States Oxford Biomedica Full time

    We use science to save lives, and so can you.We are currently recruiting for a Director of Upstream Process Development to join our Process Development group. The purpose of this role is to lead the Upstream Process Development team responsible for upstream platform development (including cell line, media, bioreactor process, plasmid transfection, and cell...

  • Director, Upstream Process Development

    3 weeks ago

    Boston, United States Oxford Biomedica Full time

    We use science to save lives, and so can you.We are currently recruiting for a Director of Upstream Process Development to join our Process Development group. The purpose of this role is to lead the Upstream Process Development team responsible for upstream platform development (including cell line, media, bioreactor process, plasmid transfection, and cell...

  • Director Drug Substance Development

    2 weeks ago

    Boston, United States STEMSourcing Full time

    Our valued client is a clinical-stage biotech company in the field of targeted protein degradation (TPD). They are looking for a talented Scientist to join their team as the Director of Drug Substance development. In this role, you will lead the Drug Substance strategic, tactical, and scientific deliverables for one of our key programs and serve as the...

  • Director Drug Substance Development

    2 weeks ago

    Boston, United States STEMSourcing Full time

    Our valued client is a clinical-stage biotech company in the field of targeted protein degradation (TPD). They are looking for a talented Scientist to join their team as the Director of Drug Substance development. In this role, you will lead the Drug Substance strategic, tactical, and scientific deliverables for one of our key programs and serve as the...

  • Director Drug Substance Development

    11 hours ago

    boston, United States STEMSourcing Full time

    Our valued client is a clinical-stage biotech company in the field of targeted protein degradation (TPD). They are looking for a talented Scientist to join their team as the Director of Drug Substance development. In this role, you will lead the Drug Substance strategic, tactical, and scientific deliverables for one of our key programs and serve as the...

Head of Process Development CMC

2 months ago

Boston, United States EPM Scientific Full time

Head of Process Development

Interested in learning more about this job Scroll down and find out what skills, experience and educational qualifications are needed. Greater Boston Area | East Coast Competitive Compensation + excellent bonus/benefits Duties and Responsibilities: To be successful in this role, deep understanding of Process Development is required. You should be able to drive continuous improvement initiatives across biopharmaceutical process development stages. Provide internal oversight for all process development activities (cell culture, cell-line banking, protein purification); along with outsourced vendor Provide strategic oversight for several programs from discovery, early-stage development, commercialization, and Launch Strategic collaboration & support across R&D/CMC, Manufacturing, Quality Operations and Business Development/Commercial Qualifications: Experience working cross functionally with senior leadership (QC, Analytical, Manufacturing, Regulatory, Business Development, etc. ) Past Experience with CHO, HEK-293, or Yeast Fermentation based Process Development Experience overseeing outsourced vendors (CDMOs) and internal R&D activities Expert authoring and strategically working on IND - BLA/MAA submissions M.S or Ph.D. in Bioengineering/Chemical Engineering or a related scientific field w/ ideally 10 or more years of industry experience

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