Supervisor, Downstream Manufacturing

JOB SUMMARY

The downstream manufacturing supervisor will lead associates during the startup and production in the purification areas for a new clinical GMP biopharmaceutical facility. The supervisor will coach associates during the commissioning, qualification, and production activities while safeguarding work environments and ensuring cGMP compliant behaviors.

JOB RESPONSIBILITIES
- Plan, schedule, and support daily production tasks to ensure schedule adherence while maintaining a successful and GMP compliant execution. Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T and PD, QA, Maintenance and Engineering, and AFS and Microbiology.
- Ensure timely execution and review of batch documentation and logbooks, initiation of deviations, and execution and completion of ERP orders. Ensure timely corrections to batch documentation and logbooks.
- Supervise, coach, mentor and train team members to maintain educated, qualified and motivated employees. Ensure staff maintain a high level of compliance to procedures and quality expectations.
- Ensure equipment and manufacturing facilities remain in working order by overseeing production technician maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair.

JOB MINIMUM REQUIREMENTS
- B.S. in a Life Sciences or Master/Engineering degree and 7+ years relevant experience or equivalent education and experience.
- Demonstrated knowledge of purification unit operations is preferred. Experience in single-use platform technology is preferred.
- Prior experience in a lead/leadership roll is preferred.
- Excellent written and verbal communication skills are required.
- Energetic, motivated and dynamic individual.
- Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
- Fluent in French, with technical English language both reading and writing.
- Computer Skills: MS Office, ERP, EDMS, production equipment software, other

The job requires working on shifts which may include working overnight as well as week-end or “on duty” working periods.
- KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization._
- KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply._