Manufacturing Process Specialist
1 week ago
Job Summary:
As a key member of the MSAT Team, you will be responsible for the successful transfer of viral vector bioprocesses into GMP production. This role requires direct contact with clients and internal cross-functional teams, ensuring seamless process scalability and manufacturability.
Responsibilities:
- Utilize process flow diagrams, learned expertise, and transferred data to transfer detailed, step-by-step manufacturing processes under the supervision of a senior MSAT scientist and/or manager.
- Perform portions of process transfer from either PD Lonza or from customers, commensurate with experience and under GMP conditions.
- Support new product introductions (NPI/technology transfers) with minimized assistance from senior engineers, as well as ongoing manufacturing runs by correcting errors and overseeing operations.
- Pursue successful resolution of complex quality system deviations, driving holistic and/or targeted solutions to ensure process and product quality.
- Participate in technology transfer and oversight, as well as process improvements, for all process steps under reduced supervision.
Requirements:
This role requires a strong understanding of bioprocesses, GMP regulations, and project management skills. The ideal candidate will have experience in process transfer, technology transfer, and quality system deviations.
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