- Aequor (Waltham, MA)
- …CMO Quality System records, manufacturing documents, analytical methods, and qualification/ validation documentation. On-site oversight of CMO operations as needed. ... to collect and monitor key performance indicators of CMO and contract /external laboratories. Review, maintain, and execute against Quality Agreements with the… more
- 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
- Takeda Pharmaceuticals (Cambridge, MA)
- …will be recognized as a technical resource/expert within SMPD and across Pharmaceutical Sciences and utilize their technical expertise to contribute across multiple ... operations, process safety evaluation as well as technical transfer to external contract manufacturing organizations. He or she will be collaborating closely with… 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
- 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
- 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
- Takeda Pharmaceuticals (Boston, MA)
- …Data, Digital & Technology (DD&T). At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led ... + Lead SaaS product selection processes, including RFI/RFP management, licensing, and contract negotiations. + Provide expert input on budgeting and reporting within… 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
