- Eurofins (Cambridge, MA)
- …transfer. This individual will play a critical role in supporting our client's GMP -compliant sample testing and analytical operations, while also serving ... Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life… more
- Takeda Pharmaceuticals (Lexington, MA)
- …efforts across four main areas: a) GMP review and control for analytical documents; b) Release testing oversight, Stability and Shelf life; c) Reference ... my knowledge. **Job Description** **How you will contribute:** + Lead and develop a global team of managers and...under cGMP's + Demonstrates effective project management skills + GMP and compliance experience required + Analytical … more
- Sanofi Group (Framingham, MA)
- …establish phase-appropriate control strategies and to develop, qualify, and validate robust analytical methods to support release and characterization testing of ... was possible. Ready to get started? **Main Responsibilities** + Participate in and/or lead the development, qualification, and transfer of analytical methods in… more
- Cambrex High Point (Waltham, MA)
- … development activities and execution of Quality Control responsibilities. They will lead the analytical team, interface with their peer chemists and ... to drug substance and fine chemical manufacture. Responsibilities Responsibilities + Lead and develop Snapdragon's Analytical Development and Quality Control… more
- Astellas Pharma (Westborough, MA)
- …Japan guidance), Astellas policies and procedures and industry best practices. The Validation Lead will ensure that all critical GMP equipment and systems are ... **Validation Lead , Quality Assurance** Do you want to be...programs, policies and procedures related to facilities, utilities, equipment, analytical equipment, cleaning validation and process performance qualification for… more
- Lilly (Boston, MA)
- …**Summary** We are looking for a proactive, scientifically grounded Director to lead the development and integration of GMP cell banking, cryopreserved ... to scale into future clinical phases. **Roles and Responsibilities** + Establish and lead a unified technical strategy that integrates GMP cell banking,… more
- Catalent Pharma Solutions (Chelsea, MA)
- … instrumentation (ie HPLC, UPLC, GC, UV-vis, FTIR, laser diffraction, KF, etc) for GMP testing of materials and product, for method transfers/validation, and for ... a Quality Control Analyst IV who is a key analytical leader in a cGMP laboratory capable of both...cGMP laboratory capable of both clinical development and commercial testing . This analyst is both a mentor and trainer… more
- Takeda Pharmaceuticals (Boston, MA)
- …multiple aspects of GMP Dengue vaccine manufacturing, specifically providing analytical testing support/troubleshooting of cell bank and working virus seed, ... to ensure safety and purity testing compliant to US Food and Administration (FDA) and...and European Medicines Agency (EMA) regulations; act as project lead on development of an in-house specialized immunoassay for… more
- Sanofi Group (Waltham, MA)
- …and optimisation by providing an appropriate statistical support and guidance to process development, analytical and CMC teams in both GMP and non- GMP ... **About the Job** As an experienced mRNA CMC Principal Statistician, you will lead and coordinate the team providing statistical support to the mRNA CoE scientists… more
- Catalent Pharma Solutions (Chelsea, MA)
- …safety of every patient, consumer, and Catalent employee.** **The Role:** + Performs analytical testing of spray dried powder using relevant methodologies (ie ... is hiring a Quality Control Analyst who is responsible for executing QC testing and related analytical activities supporting product development, release and… more