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Keywords: Director CMC, Program Management, Location: Boston, MA

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Director CMC, Program Management

better, longer. For more information, visit us at . About the Role Director CMC, Program Management As the Director CMC... effort on filing New Drug Applications (NDAs) is a must. The Director, Program Management, will also have demonstrated...

Company: Olema Oncology
Location: Boston, MA
Posted Date: 03 Aug 2025

Associate Director, Global Regulatory Affairs, CMC Small Molecules

of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director, GRA CMC Small... Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. How you will contribute: Plan...

Company: Takeda
Location: Boston, MA
Posted Date: 09 Jul 2025

Director, Regulatory Site CMC

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

Company: Takeda
Location: Boston, MA
Posted Date: 05 Jun 2025

Sr. Director, Regulatory Affairs - CMC

Affairs CMC to lead the regulatory CMC activities for our programs across all phases of development and life-cycle management...-informed global CMC regulatory strategies (US, EU, and Japan) Represent Regulatory Affairs on CMC and Program teams...

Location: Cambridge, MA
Posted Date: 09 May 2025

Sr. Director, Regulatory Affairs - CMC

Affairs CMC to lead the regulatory CMC activities for our programs across all phases of development and life-cycle management...-informed global CMC regulatory strategies (US, EU, and Japan) Represent Regulatory Affairs on CMC and Program teams...

Location: Cambridge, MA
Posted Date: 08 May 2025

Director, CMC Asset Lead (Rare Disease)

including asset strategy, development, supply and life cycle management planning for the commercial program. This PO&T Asset...About This Role The Pharmaceutical Operations and Technology (PO&T) Division is looking to hire a CMC Asset Lead...

Company: Biogen
Location: Cambridge, MA
Posted Date: 16 Jun 2025

Director, Pharmaceutical Sciences Program Leadership

leadership and program management for multiple global CMC development teams dealing with complex development programs... audience. Can represent CMC viewpoint at corporate and industry level. Resource Management - ability to anticipate and manage...

Company: Takeda
Location: Boston, MA
Posted Date: 28 Jun 2025

Director, Project Management Commercial Manufacturing and Supply Chain, Hemoglobinopathies

Job Description General Summary: This Commercial Manufacturing and Supply Chain (CMSC) Director Project Management... strategies within the Heme program. The position will work with the CMSC and CMC leads and interface directly with CDMOs...

Location: Boston, MA
Posted Date: 16 Jul 2025

Director - Manufacturing Site Inspection Management, Quality

Job Description General/Position Summary The Director, CMC Inspection Management as part of the Vertex Quality... Assurance Organization is responsible for the inspection management related to CMC activities of the internal manufacturing site...

Location: Boston, MA
Posted Date: 28 Jun 2025

Director, Alliance Management

strategic relationship management, creative problem solving, and thorough diligence. The Director of Alliance Management... will work closely with Program Management, SMEs from various functions, and senior management, to support Akebia’s existing...

Location: Cambridge, MA
Posted Date: 31 May 2025

Director, Alliance Management

strategic relationship management, creative problem solving, and thorough diligence. The Director of Alliance Management... will work closely with Program Management, SMEs from various functions, and senior management, to support Akebia’s existing...

Location: Cambridge, MA
Posted Date: 31 May 2025

Quality Sr. Specialist, Vendor Management (contract) 88888

and support of Vendor Management processes within CMC Quality. This position reports to: Director, Small Molecule CMC Compliance... with External Partners. Ensures that all the documentation associated to the Vendor Management program; risk assessment reports...

Location: Boston, MA
Posted Date: 16 Jul 2025
Salary: $55 - 65 per hour

Director, Clinical Pharmacology Lead

of brilliant and diverse minds to make a real difference, there's only one choice. Director, Clinical Pharmacology Lead The... as a subject matter expert, providing program-level functional and operational leadership to global development teams...

Company: Bayer
Location: Cambridge, MA
Posted Date: 06 Aug 2025

External Manufacturing Director

Job Description General Summary: The External Manufacturing Director Cell and Genetic Therapies, role is to oversee... clinical through post-approval lifecycle management. The right candidate will understand the challenges and make proactive...

Location: Boston, MA
Posted Date: 05 Aug 2025

Director, Product Quality (Hybrid)

Job Description The Product Quality Director is accountable for end-to-end quality oversight of small molecule... program(s) throughout clinical development, commercialization, filing, approval, launch, and post approval lifecycle...

Location: Boston, MA
Posted Date: 02 Aug 2025

Director, Regulatory Affairs - Labeling

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program... better, longer. For more information, visit us at . About the Role Director, Regulatory Labeling As the Director, Regulatory...

Company: Olema Oncology
Location: Boston, MA
Posted Date: 24 Jul 2025
Salary: $230000 - 245000 per year

Director Clinical Scientist Immunology Cell Therapy

you to join us! We are currently seeking an Director Clinical Scientist, Immunology Cell Therapy to be based in Boston Seaport. About AstraZeneca... Do The Associate Director Clinical Scientist holds an expert position within the new and dynamic immunology cell therapy...

Company: AstraZeneca
Location: Boston, MA
Posted Date: 20 Jul 2025

Executive Director, Development Asset Lead

and partner with internal leaders including PDC leads and Research/Development Unit heads. Partner with Program Management...About this Role As an Executive Director, Development Asset Lead (DAL), you will serve as a senior leader...

Company: Biogen
Location: Cambridge, MA
Posted Date: 29 Jun 2025

Senior Director, Analytical Development

About This Role As the Senior Director and Head of Analytical Development for Small Molecules & Antisense... molecule and antisense oligonucleotide portfolio. Reporting to the Head of Pharma CMC Development and Regulatory...

Company: Biogen
Location: Cambridge, MA
Posted Date: 21 Jun 2025

Associate Director, Analytical Development

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

Location: Boston, MA
Posted Date: 11 Jun 2025