- Takeda Pharmaceuticals (Boston, MA)
- …Agencies, having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience ... therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you... CMC experience including experience as an RA CMC product lead with late-stage development… more
- Bristol Myers Squibb (Devens, MA)
- …in GMP compliance, global regulations, and strong understanding of pharmaceutical product development lifecycle, with specific emphasis on gene delivery ... lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Director , Cell Therapy Global Product Quality Lead..., Quality Assurance , Q uality Control , GRS CMC to develop and execute product quality… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …including sample collection, storage conditions, and analytical testing, to support product development and regulatory submissions. + Author and review ... **Associate Director , Small Molecule Analytical Development ** +...development and optimization for drug substance and drug product at CDMOs + Design and lead method validation… 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 scientific depth and overall product development acumen for successful execution + Identifies, mitigates and communicates project or program risks… more
- AbbVie (Worcester, MA)
- …compliance state and linking this to local / global project implementation. + Leads product quality team to support development of the legal supply agreements, ... or lead of strategic programs; including Brand Teams, New Product Introductions, Product Transfers, CMC ,...range of activities are undertaken from long term strategy development to short term crisis management. The incumbent must… more
- Takeda Pharmaceuticals (Lexington, MA)
- …c) Reference Standard Management; d) GMP Quality Systems + Contribute to product development from Research to Commercialization by collaborating with multiple ... product knowledge. Including the support of transfer of development assets from Research, main ownership starting at start...+ Minimum of 10 years of experience working in CMC analytical development area for active pharmaceutical… more
- Takeda Pharmaceuticals (Lexington, MA)
- …leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory, CMC or other drug development related function. Clinical ... is true to the best of my knowledge. **Job Description** **Associate Director , Clinical Research, Value & Evidence Generation, US Medical** **Lexington, MA**… more
- Sanofi Group (Cambridge, MA)
- …Industrial Affairs (Device Development , manufacturing, quality, supply chain) and drug product development . Combination product and drug delivery device ... for device aspects of combination product submissions. + Contribute to product development planning, including strategies to bridge delivery systems during … more
- Bristol Myers Squibb (Devens, MA)
- …substance. This position reports to the Vice-President of MS&T, within BMS' Global Product Development and Supply Division. The Biologics MS&T leader will work ... with Process Development , Quality, Regulatory, and Operations to support product development , tech transfer, and life-cycle management. - Ensure all… more
- Fresenius Medical Center (Waltham, MA)
- …+ Ensure the integration of regulatory considerations into all stages of product development , including preclinical, clinical/medical, CMC , and post-market ... in influencing regulatory decisions, managing complex global submissions, and ensuring successful product development , approval, and market access for FME's … more