Sr. Director Of Cmc
hace 1 mes
Sr. Director, CMC (Protein)
Location: 3-day On-site Boston, MA HireMinds is partnering with a new biotech seeking your expertise to help in their mission to get to IND in 2025 for rare disease patients in dire need. In this role you'll be a pivotal hire working closely with the CEO and company advisors. As the Senior Director of CMC, you will lead CMC activities in recombinant protein therapy from academic development to clinical manufacturing. You'll be successful in leading CMC strategies, managing CDMO partnerships/technical transfer, and ensuring compliance with quality and regulatory standards. You'll be local to Boston and enjoy working closely in a virtual office setting with the management team and help build the development organization as the company grows. Apply today if this sounds like an exciting role for your career.
You'll Be Responsible For: CMC Development: Create and execute phase-appropriate CMC strategies, focusing initially on transition to Phase I clinical trials.CDMO Partner Management: Select and oversee CDMO partners for process development, analytical testing, and formulation, with emphasis on downstream purification and drug product topical gel formulation.Regulatory and Quality Compliance: Implement proper CMC strategies aligned with quality and regulatory requirements, preparing submissions and responding to agency feedback.Team Leadership: Provide strategic leadership, collaborate with cross-functional teams, and eventually recruit and mentor a CMC team through clinical and commercial development phases.You'll Bring With You: Ph.D. in Biochemistry, Chemical Engineering, or related field.Biotech or Pharmaceutical success with 10+ years of experience.Examples of success in downstream CMC activities preferably in recombinant protein CMC, with expertise in large, sticky, or complex proteins.Proven track record in managing CDMO partnerships and ensuring GMP compliance.Strong problem-solving skills and ability to adapt manufacturing processes for specialized proteins.Effective communicator with ability to present plans and provide clear updates to CEO and invested stakeholders on a regular basis.
#J-18808-Ljbffr
-
Regulatory CMC Director
hace 2 semanas
Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completoJob Description:The Chemistry Manufacturing Controls Director is responsible for executing global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and manages interactions with Health Authorities for CMC topics.Key Responsibilities:Leads the preparation and review of...
-
Director, Regulatory Affairs Cmc
hace 3 meses
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoPosition Summary This position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients. As the Regulatory CMC lead for these programs, you will have the opportunity...
-
Regulatory CMC Associate Director
hace 3 semanas
Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completoJob Title: Regulatory CMC Associate DirectorJob Summary: We are seeking a highly skilled Regulatory CMC Associate Director to join our team at Vertex. The successful candidate will be responsible for executing global regulatory CMC strategies for investigational and marketed products.Key Responsibilities:Lead the preparation and review of CMC sections of...
-
Associate Director, Regulatory Cmc
hace 4 semanas
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoAssociate Director, Regulatory CMC (Boston) Job Description The Chemistry Manufacturing Controls Associate Director executes multi-product global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and manages the interactions with Health Authorities for CMC topics....
-
Senior Director, Regulatory Cmc
hace 1 mes
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoSenior Director, Regulatory CMC PepGen is at an exciting time in our development. This role is for a motivated and team-oriented individual who flourishes in an environment where they can help lead and shape our future.As an integrated member of the PepGen Team, you will lead, develop, and implement robust regulatory CMC strategies and provide advice on the...
-
Director Quality Cmc Development
hace 3 meses
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoDirector of Quality CMC Development - East Coast based remote This 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.Travelis required.Position Overview: Cpl Life Sciences is looking for a Director of Quality CMC Development (Product...
-
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoThis is what you will do: Position Summary The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC) will be responsible for leading and providing global CMC regulatory support for the clinical and commercial product portfolio.You will be responsible for: Job Duties and Responsibilities Provide CMC support and...
-
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoBy 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 Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...
-
Head Of Regulatory Affairs-Cmc
hace 4 semanas
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoIronwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or...
-
Associate Director, Cmc Strategic Operations
hace 4 semanas
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoAssociate Director, CMC Strategic OperationsJob Description General Summary: In this role you will have the responsibility to advance multiple cross-functional strategic initiatives within the Pharmaceutical Sciences organization. By partnering closely with Senior leaders both within and outside of the department, you will propose strategic direction, gain...
-
Sr. Director, Business Development
hace 3 meses
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoPosition: Sr. Director, Business Development Location: GlobalJoin us as a Sr. Director of Business Development, where you will steer pivotal growth strategies and forge influential global partnerships. This senior role demands a visionary leader with a proven track record in driving high-impact business initiatives and managing elite client relationships.Key...
-
Regulatory Affairs Expert
hace 2 semanas
Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completoJob Title: Head of Regulatory Affairs-CMCJob Summary:Ironwood Pharmaceuticals seeks a seasoned Regulatory Affairs expert to lead our CMC function, ensuring compliance with global health authority regulations and guidelines. As Head of Regulatory Affairs-CMC, you will develop and execute a strategic regulatory plan to support product development and...
-
Senior Scientist – Analytical Development
hace 1 mes
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoBy 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 Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...
-
Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completoJob Summary:Jobleads-Us is seeking a skilled Senior Director Regulatory Strategy Lead CMC Device and Combination Products to join our team. In this role, you will be responsible for developing and implementing innovative pure device and combination product regulatory strategies. You will lead global regulatory submissions, work closely with cross-functional...
-
Scientist, Cmc
hace 4 semanas
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoScientist I/II, CMC - Drug Substance Responsibilities Contribute to the process development of peptides, oligonucleotides, conjugates, and key raw materials essential for PepGen's platforms.Collaborate with the discovery and analytical development team to develop optimized chromatography processes for purifying target entities.Assist in managing drug...
-
Senior Director, Pharmaceutical Development Portfolio Lead
hace 3 semanas
Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completoAbout the Role:Takeda is a leading pharmaceutical company that aims to deliver transformative therapies to patients worldwide. We are seeking a highly experienced Senior Director to lead our Pharmaceutical Development Portfolio as part of our Regulatory Affairs team.Key Responsibilities:The successful candidate will establish collaboration with Global CMC...
-
Senior Director of Global Growth
hace 2 semanas
Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completoJob Title: Sr. Director, Business DevelopmentAbout the Role:Jobleads-Us is seeking a Sr. Director of Business Development to steer pivotal growth strategies and forge influential global partnerships.Main Responsibilities:• Shape and execute strategic growth plans• Develop and nurture key global partnerships• Lead high-stakes negotiations and strategic...
-
Sr Director Of Product Management
hace 3 meses
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoSr Director of Product Management- Life InsuranceSr Director of Product Management- Life Insurance Location: Boston, Massachusetts / Toronto, OntarioTime Type: Full TimePosted on: 3 days agoVous cherchez un milieu de travail axé sur le soutien et la collaboration, avec des équipes formidables et des gestionnaires inspirants? Vous êtes au bon endroit. Nous...
-
Executive Director of Global Growth
hace 4 semanas
Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completoJob Title: Sr. Director, Business DevelopmentLocation: GlobalWe are seeking a visionary leader to drive transformative growth as a Sr. Director of Business Development. In this pivotal role, you will shape and execute strategic growth plans, develop and nurture key global partnerships, and lead high-stakes negotiations and strategic decisions.Key...
-
Executive Director Of Advancement, Data
hace 4 semanas
Puerto Diablo, Puerto Rico Buscojobs PR C2 A tiempo completoExecutive Director of Advancement, Data & Technology About the Company Dedicated government agency serving local judicial, legislative & executive branches IndustryGovernment Administration TypeGovernment Agency Founded1876 Employees10,001+ Categories GovernmentNursing and Residential Care About the Role The Company is seeking an Executive Director of...