- Editas Medicine (Cambridge, MA)
- …cross-functional teams in the execution of these submissions. Key Responsibilities: + As the Director , Regulatory CMC , you will be responsible for: + Provide ... in the Editas regulatory affairs organization by keeping abreast of global CMC regulatory requirements and ensure that project team colleagues and management… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you will provide program ... leadership and develop CMC regulatory strategy for global vaccine programs in various stages of development. You will represent the vaccine regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives. You will also influence… more
- Sanofi Group (Cambridge, MA)
- …products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global R&D. ... **Job title: Device Regulatory Lead (Associate Director )** + Location: Bridgewater, NJ or Swiftwater, PA or Cambridge, MA **About the job** The Global … more
- Takeda Pharmaceuticals (Boston, MA)
- …Provides strategic scientific leadership and program management for multiple global CMC development teams dealing with complex development programs that require ... as functional expert in divisional and cross-divisional initiatives. + Represents CMC on cross-divisional governance and development teams while providing strategy… more
- Editas Medicine (Cambridge, MA)
- …distribution of non-GMP materials at all locations. Key Responsibilities: As the Sr. Director , Supply Chain, you will be responsible for: + Building out all aspects ... and Technical Operations and partner with leadership in TechOps, ClinOps, Finance, CMC and Program Teams to lead short-term integrated production and raw materials… more
- Novo Nordisk (Watertown, MA)
- …drug substance and resolve technical issues or deviations + Author and review relevant CMC sections for US and ex-US regulatory filings, including NDAs + Work ... Development - Boston and will work closely with other functions of CMC drug development, including Drug Product, Analytical Sciences, Quality Assurance, and Supply… more
- Bristol Myers Squibb (Cambridge, MA)
- …a difference. As part of the Discovery Biotherapeutics efforts at BMS, the Senior Director of Protein Engineering will play a key role in discovering and delivering ... a first-in-class and best-in-class Biotherapeutics pipeline. The Senior Director , Protein Engineering, will be responsible for leading a team of 20+ scientists… more
- Lilly (Cambridge, MA)
- …improvements in healthy outcomes for our customers. We are seeking an Executive/Senior Director - DDCS Drug Delivery and New Product Innovation to partner with R&D ... the Medicines Innovation Hub and the Business Units, as well as leaders in Regulatory and Manufacturing to define and deliver our strategy. This individual will be… more
- ThermoFisher Scientific (Cambridge, MA)
- …experience in Pharmaceutical Industry, including Manufacturing, Quality Control, Quality Assurance, CMC , Regulatory or related compliance experience with at ... in the mission to holistically assess the state of quality and regulatory compliance across PSG global manufacturing/testing sites via fully independent audit… more
- Takeda Pharmaceuticals (Boston, MA)
- …empowering environment. As part of the SMPD team, you will report to Director , Process Chemistry TMA. Our Synthetic Molecule Process Development (SMPD) team develops ... chemical processes for drug substance manufacture, enduring compliance with regulatory standards. + Collaborate with our Pharmaceutical Sciences colleagues and… more