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Keywords: Director Site CMC, Location: Boston, MA

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Director Site CMC

of what is possible in order to bring life-changing therapies to patients worldwide. The Director Site CMC ensures efficient and compliant... management of regulatory change control and post-approval activities at the site level. Supporting diverse modalities—including...

Company: Takeda
Location: Boston, MA
Posted Date: 04 Jun 2025

Product Quality Director, CMC Small Molecule QA

, site QA/QC, and regulatory CMC) and commercial functions (i.e., AS&T, MS&T, QC, QA Operations, Supply Chain) to enable...Job Description The Product Quality Director is accountable for end-to-end quality oversight of small molecule...

Location: Boston, MA
Posted Date: 17 May 2025

Director, Regulatory CMC - Cell & Gene Therapy

Job Description General Summary: The Director, Regulatory CMC leads a cross-functional team in the execution... of global regulatory CMC strategies for investigational and marketed cell and gene therapy products. This role is accountable...

Location: Boston, MA
Posted Date: 19 Apr 2025

Associate Director, Analytical Development

Director specializing in analytical CMC strategy to provide scientific leadership within and across functional areas. The... Associate Director, Analytical CMC Strategy is the primary analytical liaison for their program(s) and will lead, coordinate...

Location: Boston, MA
Posted Date: 11 Jun 2025

Director, Commercial Operational GMP Quality (Hybrid)

Job Description General Summary: The Director, Commercial Operations GMP Quality role for Biologics and Combination..., and CMC product development activities. Establishment Commercial Quality Agreements and maintain close oversight...

Location: Boston, MA
Posted Date: 06 Jun 2025

Director, External Manufacturing Technology

we remain on the forefront of science, medicine and technology. We are seeking a dynamic and experienced Director, External... Manufacturing Solutions to join our team and drive our digital transformation initiatives. The Director, External Manufacturing...

Location: Boston, MA
Posted Date: 31 May 2025

Director, Research Data Compute and Consumption

we remain on the forefront of science, medicine and technology. We are seeking a dynamic and experienced Director, Data... Compute and Consumption Solutions to join our team and drive our digital transformation initiatives. The Associate Director...

Location: Boston, MA
Posted Date: 30 May 2025

Technology Transfer Director, Cell & Gene Therapies

Job Description Technology Transfer Director, Technology Transfer Leader, Cell, Gene, and Biological Therapies... for successful technology transfer of manufacturing processes from the sending site to the receiving site. The range of tech transfers may...

Location: Boston, MA
Posted Date: 24 May 2025

Associate Director / Director, Quality Control

therapy. Job Summary: Mythic Therapeutics is searching for a dynamic AD/Director, Quality Control to join our growing... Quality team. The AD/Director, Quality Control will be responsible for ensuring analytical methods are appropriately...

Location: Boston, MA
Posted Date: 17 May 2025

Associate Director / Director, Quality Control

therapy. Job Summary: Mythic Therapeutics is searching for a dynamic AD/Director, Quality Control to join our growing... Quality team. The AD/Director, Quality Control will be responsible for ensuring analytical methods are appropriately...

Location: Boston, MA
Posted Date: 17 May 2025

Director, Digital Process Control Solutions

we remain on the forefront of science, medicine and technology. We are seeking a dynamic and experienced Director, Digital... Process Control Solutions to join our team and drive our digital evolution initiatives. The Director, Digital Process...

Location: Boston, MA
Posted Date: 16 May 2025

Associate Director, Analytical Product Quality (Onsite)

Job Description The Associate Director, Analyt ical Product Quality is accountable for end-to-end technical quality... development and implementation of CMC and Analytical Quality standards for products and processes for stage gate deliverable...

Location: Boston, MA
Posted Date: 24 Apr 2025

Global Development Scientist Associate Director

you to join us! We are currently seeking an Global Development Scientist Associate Director, Immunology Cell Therapy to be based in Boston Seaport.... What You’ll Do The Global Development Scientist Associate Director holds an expert position within the new and dynamic...

Company: AstraZeneca
Location: Boston, MA
Posted Date: 12 Apr 2025

Director, Global Quality Systems - Governance (Hybrid)

Job Description The Director, Global Quality Systems, provides strategic leadership and direction in the design... oversight/governance and operational experience in CMC and one additional GxP area (e.g., GCP, GVP); experience across regions...

Location: Boston, MA
Posted Date: 10 Apr 2025

Financial Planning & Analysis Associate Director- Cell & Gene Therapy Manufacturing

biotechnology industry. The Associate Director of FP&A, Cell & Gene Therapy Manufacturing is key member of Vertex's Financial... & Control (CMC) functions supporting Cell and Gene Therapy (CGT) functions within our Biopharmaceutical Sciences...

Location: Boston, MA
Posted Date: 10 Apr 2025

Director, Financial Planning & Analysis - R&D Portfolio

of a leader in the biotechnology industry. As the Director of FP&A - R&D Portfolio, you will report to the VP of R&D Finance...: As Director of FP&A - R&D Portfolio, your key contributions will be the following: Strategic Financial Planning and Analysis...

Location: Boston, MA
Posted Date: 10 Apr 2025

Associate Director, Audit Management - Medical Device (Remote)

Job Description The Audit Management Associate Director is responsible for the audit and inspection management... GMP audit processes GMP quality systems Regional/international knowledge of GMP regulations CMC documentation...

Location: Boston, MA
Posted Date: 10 Apr 2025

Senior Director Clinical Scientist

leadership skills? If so, we invite you to join us! We are currently seeking a Senior Director Clinical Scientist, Immunology... decisions driven by patient outcomes. What You’ll Do The Senior Director Clinical Scientist holds an authoritative position...

Company: AstraZeneca
Location: Boston, MA
Posted Date: 03 Apr 2025

Senior Clinical Project Manager/Clinical Project Manager (Remote)

up (CMC, Reg, etc). Ensure timeline collection of all start-up documents (example ethics documents for submission), site... Clinical Trial Agreements and start up activities are performed prior to each site activation. Work closely with the Director...

Company: Glycomine
Location: Boston, MA
Posted Date: 11 Jun 2025