- 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)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule...CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.… more
- Sanofi Group (Framingham, MA)
- …to process development activities. + Broad knowledge of (bio)pharmaceutical development and CMC activities in a regulatory context, including good understanding ... discovery and development to find answers for patients and their families. The CMC -Biologics Statistics team is seeking an expert data scientist / Statistician to… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Pharmaceutical Sciences Program Leadership where you will be responsible for ... Sciences Early-Stage Portfolio team, you will report to Pharmaceutical Sciences ( CMC ) Early-Stage Portfolio Leader and mentor and cultivate best practices in… 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
- Takeda Pharmaceuticals (Boston, MA)
- …Be well versed in all stages of pharmaceutical development and understands the global regulatory trends for CMC activities, to ensure robust and high-quality ... to the best of my knowledge. **Job Description** **OBJECTIVES** **:** + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of… more
- Novo Nordisk (Lexington, MA)
- … Work with the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both ... ready to make a difference? The Position The Medical Director serves as the subject matter expert for our...with, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver… more
- Takeda Pharmaceuticals (Boston, MA)
- …and scientists in the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all ... to overall functional direction globally and represent function within CMC /Pharmaceutical Science and across the global Takeda organization. **ACCOUNTABILITIES:** +… 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
- Takeda Pharmaceuticals (Lexington, MA)
- …in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. + ... with significant experience within related functions (eg, Medical Affairs, Clinical Operations, Regulatory , CMC , Marketing). + Minimum of 5 years' experience as… 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
- Takeda Pharmaceuticals (Boston, MA)
- …BLA/MAA regulatory submissions. Knowledgeable in European, Japanese, Chinese and US CMC regulatory requirements for Biologics + Represents AD and provide ... of my knowledge. **Job Description** **_Objective / Purpose:_** As an Associate Director in Analytical Development, it is expected that the individual will… more
- Takeda Pharmaceuticals (Boston, MA)
- …development functions. + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and ... and transfer; + Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory documentation. **More about… more
- Novo Nordisk (Lexington, MA)
- …a living. Are you ready to make a difference? The Position The Senior Director can be accountable for the Clinical pharmacology strategy for phase 1-4 in Clinical ... Will interact with Medical Specialists, Clinical Operations, Medical writing, Regulatory , Data Science (statistics, pharmacometrics), Research and Early Development,… more
- Orchard Therapeutics (Boston, MA)
- … Regulatory Science team managing submissions for late-stage programs, and/or to the Regulatory CMC team, on an ad hoc basis. This position offers ... Location: London, UK (or Boston, US) Reporting to: Director , Regulatory Science Early-Stage Programs Job Summary This role will report to the Director , … more
- Bristol Myers Squibb (Cambridge, MA)
- …in biopharma. 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
- Merck (Boston, MA)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas) ... & Division organization of our company. **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core member of Early Drug Development… more
- Takeda Pharmaceuticals (Boston, MA)
- …You will also prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and reports ... part of the Analytical Development team, you will report to Associate Director , Analytical Development. **How you will contribute:** + Develop and leverage strategic… more
- Sanofi Group (Framingham, MA)
- Associate Director , Commercial Cell Culture Development Location: Framingham, MA **About the Job** Are you ready to shape the future of medicine? The race is on to ... Join our global Cell Culture Development (CCD) organization as the Associate Director , Commercial Cell Culture Deveopment with the mission to develop robust,… more