- Merck & Co. (Boston, MA)
- …management of an important inflection point in the drug development process , working closely with scientific, regulatory, statistical, and modelling colleagues ... seeking a highly qualified physician-scientist with a proven track record in the pharmaceutical industry as well as independent academic research for a position in… more
- Cytel (Cambridge, MA)
- …statistical support for CMC-related studies, including formulation development, stability studies, process validation , and analytical method validation . ... same. Sponsor-dedicated: Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind...you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next… more
- BioSpace (Norwood, MA)
- …for packaging equipment. Provide input into user requirements, design specifications, process parameters, and FMEA assessments. Establish and maintain best practices ... phases of engineering projects, from conceptual design to commissioning, validation , and qualification. Troubleshoot equipment failures, contribute to preventative… more
- Monte Rosa Therapeutics, Inc (Boston, MA)
- …and execution of biochemical and cellular assays for hit finding, hit validation , mechanism of action studies and medicinal chemistry profiling. The ideal candidate ... in Enzymology, Biochemistry, Biology, or related field or equivalent pharmaceutical /biotech experience is required. Experience with developing biochemical and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …per Food Drug Administration (FDA)/Company guidelines; draft Specification documents and Validation Plans (VPs) for pharmaceutical manufacturing and laboratory ... Reports (VSR) etc. per Food Drug Administration (FDA) and other US pharmaceutical regulations; Analyze validation data, prepare reports and make recommendations… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking a highly skilled, self-motivated **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in ... and immunology. You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially other global regulatory standards… more
- Bristol Myers Squibb (Devens, MA)
- …careers.bms.com/working-with-us . **Summary:** The Senior Engineer - IT Computer System Validation , Cell Therapy Devens role will provide support to the Digital ... the Devens Cell Therapy Facility (CTF) through managing the computerized system validation (CSV) activities / major projects and supporting deviations and change… more
- Nestle (Waltham, MA)
- …is preferred. * Experience with authoring and reviewing technical content in support of process validation and/or regulatory filings such as IND, BLA, PAS is ... NHSc's pharmaceutical products. **Key Responsibilities:** * Serve as a process SME for NHSc products and manufacturing processes, providing troubleshooting and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …to pilot plant and commercial-scale production, ensuring smooth technology transfer and process validation . + Has full accountability for all engineering aspects ... processes. + Responsible for authoring relevant sections of regulatory documents, validation plans, development reports, process flow diagrams (PFDs), piping… more
- Sanofi Group (Framingham, MA)
- …modeling workflows. + Support mechanistic modeling initiatives for bioprocessing or pharmaceutical unit operations, including model calibration, validation , and ... **Job Title:** Winter/Spring 2026 Co-op-Intern - Process Modeling - Data Science - MSAT **Grade:**...concepts is a plus. + Familiarity with bioprocesses or pharmaceutical unit operations. + Experience working with data visualization… more
