- Cambrex High Point (Waltham, MA)
- …NMR, TGA, DSC, particle size analyzer etc. to characterize and quantitate pharmaceutical synthetic molecules. Knowledge of regulatory guidelines and experience ... a PhD with 1+ years of experience in analytical chemistry within the pharmaceutical industry. The candidate should have a broad experience of method development of… more
- Cambridge Isotope Laboratories, Inc. (Andover, MA)
- …high technology markets. CIL's growing customer base spans academia, pharmaceutical , medical diagnostic and semiconductor industries enabling collaborations with ... development and drive market growth. CIL is a subsidiary of the Otsuka Pharmaceutical Group and has had consistent growth for over 40 years. The Environmental,… more
- Adecco US, Inc. (Cambridge, MA)
- …**MSAT Synthetics and Oral Solids** group, supporting **CMC development and pharmaceutical technical activities** for new R&D compounds, Life Cycle Management (LCM) ... (M&S) programs, working closely with cross-functional Sanofi divisions (R&D, Regulatory , Commercial GBUs, Alliance Management, etc.), internal support laboratories,… more
- Bristol Myers Squibb (Devens, MA)
- …Product Quality organization . The Sr. Director a uthor s designated sections of regulatory filing s , review s all sections for clarity, technical persuasiveness , ... quality strategies that comply with internal and external quality standards and regulatory requirements. + Provide global product quality oversight of assigned areas… more
- Cognizant (Boston, MA)
- …**_Qualifications_** 10+ years of experience in Testing & Validation within the pharmaceutical or life sciences domain, with a focus on digital transformation and ... and Computer Software Assurance (CSA) processes Knowledge on ALM Test management tool Regulatory Knowledge: Strong understanding of FDA, EMA, GxP, and 21 CFR Part 11… more
- Sumitomo Pharma (Boston, MA)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory , Early Clinical Development, Pre-clinical research, Medical Affairs and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. ... Takeda pipeline compound(s) taking into consideration the medical, scientific, regulatory and commercial issues. + Leads or joins multi-disciplinary, multi-regional,… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines, ... collection, storage conditions, and analytical testing, to support product development and regulatory submissions. + Author and review INDs, NDAs, and other … more
- Sanofi Group (Cambridge, MA)
- …while maintaining full compliance with relevant company, industry, legal and regulatory requirements + Demonstrate operational understanding and risk management by ... sharing information and answering questions based on approved material within Regulatory guidelines. + Engages with appropriate stakeholders to understand the state… more
- Sumitomo Pharma (Boston, MA)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... Team. + Collaborate with the process and analytical development, quality, and regulatory functions to establish a robust, compliant clinical supply chain to support… more