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Job Description
Ability to work in a GLP or GMP environment with appropriate documentation and safety practices.
Responsible for utilizing analytical methodologies, systems and processes to support GMP release and stability testing of clinical supplies for drug substance and drug product, throughout all phases of development. This may include excipient, packaging and post packaging support
Analytical testing would include: compendial testing (e.g., excipients / packaging release testing), disintegration, dissolution, HPLC/UPLC, SFC, generic testing (e.g., solvents, water, ash, titrations, heavy metals, ICP/MS, UV) and compound specific methods
Set up and analysis of drug substance and drug product stability samples
Method development and validation of analytical methods for drug substance and drug product
Leadership responsibilities are in addition to technical roles both in and outside of the lab
Provide managerial oversight of on-site team personnel
Serve as liaison between the client and the team
Lead team, schedule, and train employees in client environment
Ensure adherence to highest quality and efficiency standards in laboratory operations
Ensure coverage and performance
Foster morale and teamwork
Provide process improvements and best practices to support Operational Excellence initiatives
