- Sanofi Group (Cambridge, MA)
- **Regulatory Affairs Innovation Lead - VIE Contract ** + _Location: USA, Cambridge_ + _Target start date:_ _01/12/2025_ iMove, the Sanofi VIE Program, is available to ... _In this role, you'll work on the innovation funnel for discovery and validation of innovative ideas, solving tomorrow's problems today and making ideas from good… more
- Charles River Laboratories (Shrewsbury, MA)
- …as appropriate. Serve as a Project Scientist for the development and validation of analytical assays. This individual would be responsible for the composition ... and execution of validation and sample analysis protocols/plan in accordance with company...projects, prioritize work and meet deadlines. Experience in a contract research organization is preferred. * Proficiency in the… more
- Charles River Laboratories (Shrewsbury, MA)
- …responsibilities include serving as a Principal Investigator for the development and validation of biomarker, PK and ADA assays (eg: ligand binding assays, enzymatic ... This individual would be responsible for the composition and execution of validation and sample analysis protocols/plan in accordance with company standard operating… more
- Astellas Pharma (Westborough, MA)
- …as at contract labs and CMOs. + Support QC equipment validation , maintenance, calibration, and QC laboratories scheduling and maintenance. + Participate and own ... you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries...manufacturing samples for QC analysis, ship samples to the contract labs testing, review data for lot disposition. +… more
- Curia (Hopkinton, MA)
- …where our work has the power to save lives Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering ... with pharmaceutical and biotech companies to provide life-saving treatments to...+ Oversee and implement on-floor QA + Review Executed/Unexecuted Validation /Facility Protocols/Reports + Investigate and write documentation for Unplanned… more
- ThermoFisher Scientific (Boston, MA)
- …in the future. Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, ... employee, to gain direct experience working onsite at a pharmaceutical / biopharmaceutical company, all while maintaining full-time benefits. **Key… more
- Amgen (Cambridge, MA)
- …responsible for late phase analytical development, including method development, method validation , method transfer, process and product development support, and GMP ... chiral purity and structure elucidation using mass spectrometry + Manage activities at contract manufacturing and testing sites. + May lead method transfer to CMO or… more
- ThermoFisher Scientific (Plainville, MA)
- …testing of toxicological, clinical, and commercial grade biopharmaceuticals, qualification/ validation of analytical methods for support of cGMP manufacturing, ... and the transfer and validation of assay methods from clients and/or Assay Development...for Molecular, Viral, Cell, and Tissue Culture operations and contract testing. Ensure compliance, accuracy, and timeliness of testing… more
- Catalent Pharma Solutions (Chelsea, MA)
- …Engineer II** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, ... manufacturing. The candidate provides support in automation engineering, design, and validation . The Automation Engineer II contributes to the design and… more
- Takeda Pharmaceuticals (Boston, MA)
- …with evolving assumptions + Utilize cost models and workbooks to validate contract pricing and budget assumptions for complex agreements and develop enhancements to ... improve validation capabilities + Drive negotiations with CRO's and suppliers...suppliers to secure optimal terms for Takeda + Manage contract amendments throughout the study lifecycle + Support study… more
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