About the position
This position is 7 pm- 7 am on a 2-2-3 schedule. The downstream manufacturing associate will participate in the purification areas for a clinical and commercial GMP biopharmaceutical facility. The associates will perform production activities while safeguarding work environments, employing cGMP compliant behaviors, and following principles to ensure 'Right the First time' execution. The ideal candidates can demonstrate that they have learning agility, are action oriented, drive for results, are excellent team workers, have a strong attention to detail, and have superior integrity and accountability. Downstream manufacturing associates will be responsible for chromatography, filtration, viral inactivation and bulk fill operations and should be familiar with mixing vessels, chromatography equipment, filtration equipment, protein concentration analytical measurement equipment, and other general biotechnology auxiliary equipment such as balances, pumps, pH meters, filter integrity testers and conductivity meters. Experience using single use equipment is desired. Associates will execute daily tasks and maintain strict accordance with manufacturing records, SOPs and Good Manufacturing Practices. Staff will maintain a sense of ownership of the production processes, the manufacturing environment and the facility. Staff will work cross-functionally with QA, MS&T, facilities and other key departments to ensure ongoing manufacturing operations are successful, reliable and compliant. The senior manufacturing associate will also be responsible for performing production activities with minimal supervision and effectively communicating with the manufacturing supervisor and support groups. Staff will use their depth and knowledge of purification fundamentals to teach, troubleshoot and continuously improve the daily operations of downstream manufacturing. Senior manufacturing associates will also be expected to review the manufacturing schedule, executed manufacturing documentation, and ERP orders to ensure compliant operations and schedule adherence. Staff will effectively communicate questions, concerns, or deviations as appropriate.
Responsibilities
- Execute daily production tasks to ensure schedule adherence while maintaining a successful and GMP compliant execution.
- Ensure training and qualification is completed as required and is maintained at a high level. Train less experienced staff on procedures.
- Ensure timely review of batch documentation and logbooks, initiation of deviations, and execution and completion of ERP orders. Ensure timely corrections to manufacturing records, documentation, and logbooks.
- Ensure equipment and manufacturing facilities remain in working order by executing maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair.
- Execute additional manufacturing activities and process support with other manufacturing groups, MS&T and PD, QA, Maintenance and Engineering, and AFS and Microbiology.
- Author and review manufacturing procedures.
Requirements
- Sr. Manufacturing Associate I: H.S Diploma or Equivalent and 8+ years of relevant experience or B.A./B.S. in a Life Sciences or Engineering degree and 2+ years relevant experience or equivalent education and experience.
- Sr. Manufacturing Associate II: H.S Diploma or Equivalent and 10+ years of relevant experience or B.A./B.S. in a Life Sciences or Engineering degree and 4+ years relevant experience or equivalent education and experience.
