The Andover Site Technical Services Group (ASTS) is seeking a highly motivated individual for a Principal Process Scientist/Engineer. The ideal candidate will have hands on leadership experience with large scale biopharmaceutical processes/equipment principles and practices. A strong regulatory compliance and Good Manufacturing Practice mindset/experience is highly required.
The role encompasses the ongoing lifecycle process/product management of commercial and near-commercial biopharmaceuticals drug substances compounds including development and implementation of regulatory post approval process changes. The individual will be expected to provide detailed technical leadership, process understanding and expertise in support of processes within all manufacturing suites at the Andover, MA manufacturing site including both mammalian and bacterial processes. A track record of solving complex technical, regulatory, compliance and operational issues through collaboration with stakeholders and other scientists, engineers, operations, and quality control/quality assurance groups. Familiarity with Lean/Six-Sigma methodologies is desirable.
Role Success Factors
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
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