Biotechnology manufacturing associate

Summary

The incumbent is responsible for supporting operations in the cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies. This role will work closely with the Process Sciences, Vector Sciences, and Manufacturing Sciences and Technology (MSAT) teams to transfer and execute clinical manufacturing processes, and establish procedures for equipment and manufacturing operations.

Key Roles and Responsibilities

• Work collaboratively with the MSAT, Quality, Process Sciences, and Vector Sciences teams on all aspects of facility qualification and start-up.
• Support the development of the operating paradigm for GMP cell therapy and viral vector manufacturing operations.
• Assist in development and implementation of GMP procedures and policies related to Manufacturing Operations.
• Execute manufacturing operations safely, as scheduled, and right the first time for delivery of treatment to patients.
• Maintain production facilities at a high standard of cleanliness and organization, perform equipment maintenance and calibrations as required, and complete and review GMP documentation in a timely manner.
• Maintain appropriate level of training for assigned responsibilities.
• Work with TechOps teams to execute technology transfers and capacity-building projects.
• Identify and mitigate risks in the manufacturing areas that could negatively impact the quality of patient therapies.
• Use strong communication and teamwork skills to build relationships across the manufacturing site.
• Demonstrate technical acumen, operational understanding, and GMP compliance in managing the manufacturing operations.
• Support operational excellence initiatives, and the implementation of new technologies and systems.
• Ensure a strong culture in safety and GMP compliance.

Skills

Knowledge, Skills, and Abilities

Physical Requirements

Shift Work, Weekend Work, and Holiday Coverage

Education