Biopharmaceutical Process Specialist
4 days ago
Join us at Next Generation as we seek a Biopharmaceutical Process Specialist to contribute to our dynamic and highly technical global team.
About the PositionThe successful candidate will be responsible for key contributor roles in the development of downstream manufacturing technologies, collaborating with Manufacturing, Engineering, Quality Assurance, Quality Control, and Global Regulatory Sciences groups.
Responsibilities-- Possess a thorough knowledge of the science behind the molecule and associated drug substance manufacturing processes, with expertise in one or more of the following areas: upstream (cell culture focus), downstream (buffer preparation, purification, and viral reduction steps).
- Author technical documents, including protocols, reports, and SOPs, to support validation of the manufacturing process.
- Lead the implementation of process improvements, such as yield optimization and cycle time reduction, through evaluation of process performance using data analytics tools.
- Serve as a process subject matter expert for regulatory inspections and interactions with regulatory agencies.
A minimum BSc or equivalent with at least 2 years of experience in drug substance manufacturing technical support within the biopharmaceutical industry is required.
Demonstrated awareness of cGMP compliance and regulatory agency requirements is essential. Excellent interpersonal skills and ability to work effectively in a cross-functional global environment are also required.
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