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Keywords: Director, Regulatory Strategy, Cell & Gene Therapy, Location: Boston, MA

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Director, Regulatory Strategy, Cell & Gene Therapy

and implementation of innovative global/regional regulatory strategies for assigned projects within the Vertex cell and gene therapy...Job Description General Summary: The Director, Regulatory Strategy will be responsible for the development...

Location: Boston, MA
Posted Date: 24 May 2025

Commercial Supply Chain Director, Cell & Gene Therapy

, Finance, Regulatory, Commercial, Logistics, Manufacturing, and Vertex’s Cell and Gene Therapy Site. The Director...Job Description Summary: The Director of Cell and Gene Therapy Commercial Supply Chain will lead the slot...

Location: Boston, MA
Posted Date: 08 May 2025

Senior Director, GMP Operational Quality - Cell & Gene (Onsite)

Quality Operations for the Manufacturing of Cell & Gene products. The role will be responsible for leading the Quality on site... and testing activities, including disposition of intermediates, clinical and commercial cell therapy products internally at Vertex...

Location: Boston, MA
Posted Date: 17 May 2025

Executive Medical Director, Immunology Cell Therapy

Job Profile: Executive Medical Director, Immunology Cell Therapy Location: Office-based role in Boston Seaport... Professional qualification in Oncology and/or Hematology (Immunology allowed) Relevant experience in the field of cell and gene...

Company: AstraZeneca
Location: Boston, MA
Posted Date: 07 Jun 2025

Director, Global Value & Access Strategy (Heme+Early Pipeline Portfolio)

therapy for sickle cell disease and beta-thalassemia, and JOURNAVX, a first-in-class treatment for moderate-to-severe acute... and has successfully developed and commercialized multiple breakthrough medicines for Cystic Fibrosis (CF) as well as CASGEVY, a gene...

Location: Boston, MA
Posted Date: 06 Jun 2025

Director, Global Value & Access Strategy, povetacicept

multiple breakthrough medicines for Cystic Fibrosis (CF) as well as Casgevy, a gene therapy for sickle cell disease and beta...Job Description Director, Global Value Access & Strategy, povetacicept Location: Boston, MA (3 days onsite, 2 days...

Location: Boston, MA
Posted Date: 10 Apr 2025

Associate Director, Analytical Development

used for cell and gene therapy products and knowledge of the cGMPs, USP/ICH, and regulatory guidance for commercial-stage...: Must have experience with cell and gene therapy CMC development (CQAs, specifications, comparability) from late-stage development...

Location: Boston, MA
Posted Date: 11 Jun 2025

Director, External Manufacturing Technology

GMP. Experience with the manufacturing processes of small molecule, cell therapy, gene therapy and other modalities... external manufacturing data and technology strategy supports broader organizational objectives and regulatory requirements...

Location: Boston, MA
Posted Date: 31 May 2025

Senior Director, Clinical Pharmacology

Clinical Pharmacology efforts for small molecule and novel modality programs, such as gene editing, gene therapy, and cell... Pharmacology efforts for small molecule and novel modality programs, such as gene editing, gene therapy, and cell therapy, in the...

Location: Boston, MA
Posted Date: 29 May 2025

Director, Digital Process Control Solutions

-modality medicine portfolio currently including small molecule, cell therapy and gene therapies, a global CMC scientific team..., cell therapy, gene therapy and other modalities. Co-Location Requirement This is a hybrid role based in Boston...

Location: Boston, MA
Posted Date: 16 May 2025

Associate Director, Operational Area Quality, Materials Management (Hybrid)

and experience across GXP life cycle in Cell & Gene therapy and/or Biologics. Experience in product life cycle from discovery... member of the Vertex Cell & Genetic Therapy Quality Team and the Operational Product Teams. Key Duties & Responsibilities...

Location: Boston, MA
Posted Date: 10 Apr 2025

Director, Global HEOR - Chronic Pain

multiple breakthrough medicines for Cystic Fibrosis (CF) as well as Casgevy, a new gene therapy for sickle cell disease...Job Description Director, Global HEOR, Chronic Pain Location: Boston, MA (3 days onsite, 2 days remote weekly...

Location: Boston, MA
Posted Date: 10 Apr 2025

Associate Director, Quality Assurance CMO Management (Hybrid)

. Knowledge and Skills: In-depth global regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy... of regulatory environment, including quality systems, compliance, and strategy. Broad technical knowledge in Cell technology...

Location: Boston, MA
Posted Date: 10 Apr 2025

Associate Director, Patient Advocacy

Therapeutics is a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the... development of innovative, curative cell and gene therapies. Orchard has its global headquarters in London and U.S. headquarters...

Location: Boston, MA
Posted Date: 03 Apr 2025

Biopharmaceutical Sciences and Manufacturing Operations (BSMO) Program Lead, Executive Director, Casgevy

Operations at Vertex. Casgevy is a CRISPR-derived genetic therapy that treats the underlying cause of Sickle Cell Disease... will report to the VP of Manufacturing Science and Technology (MSAT) for Cell and Gene Therapies within the Commercial...

Location: Boston, MA
Posted Date: 05 Jun 2025

Senior Manager, Clinical Supply Chain

and Cell Therapy products. You are interested in… Developing and executing clinical supply chain strategies from study... therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera...

Posted Date: 06 Jun 2025