- AbbVie (Waltham, MA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Advance your career as Director , CMC Product Development , where you'll oversee ... champion quality and resource management. + Develops, updates, and implements CMC product development plans while ensuring regulatory, health, safety, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …Agencies, having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience ... oversee the development and execution of regulatory CMC development and registration strategies. You will...Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** As a CMC Lead, Small Molecules (Associate Director ), you will be responsible for leading ... to the world. **How you will contribute:** + Provide strong direction to CMC Leads to drive effective life cycle management for Takeda's commercial small molecule… more
- Bristol Myers Squibb (Devens, MA)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . The ** Director , Vector Product Champion** is accountable for leading an ... risks, and ensuring technical alignment with stakeholders. As a key member of the CMC and Global Operations (GO) Team, the Product Champion will deliver… more
- Bristol Myers Squibb (Devens, MA)
- …alongside some of the brightest minds in Biopharma. **Position Summary** The Senior Director , Head of Potency and Impurity Assay Development (PIAD) reports to ... next generation of scientific and organizational leaders. **Key Responsibilities** The Senior Director , Head of Potency and Impurity Assay Development (PIAD),… 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
- Sumitomo Pharma (Boston, MA)
- …and FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical industry + Experience reviewing ... late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For...highly motivated, and experienced individual for the position of ** Director Regulatory Affairs** . The Director is… 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
- 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 (Boston, MA)
- …Activities, Process / Product knowledge. + Leads projects within Takeda product portfolio, both development and commercial, to support Small Molecules API ... true to the best of my knowledge. **Job Description** **Title: Associate Director -Process Engineer SM API Process Sci** **Location: Cambridge, MA (Hybrid)** **About… more