Manufacturing Supervisor β Aseptic Upstream Bioprocessing
Elanco
Manufacturing Supervisor β Aseptic Upstream Bioprocessing
Responsibilities:
- Lead daily aseptic bioprocessing manufacturing operations (cell expansion, upstream processing/production) and coordinate with downstream and fill/finish to meet schedules.
- Supervise, coach, and develop manufacturing personnel via performance management, training, and feedback.
- Ensure activities comply with USDA, EMA, and cGMP requirements, approved procedures, and batch production records.
- Maintain a strong presence on the production floor to promote safe work practices, operational excellence, quality, and accountability.
- Coordinate with Quality, Engineering, Maintenance, Validation, Supply Chain, and other teams to support compliant operations.
- Monitor production performance, equipment readiness, schedule adherence, and ensure batch records/SAP transactions/documentation are completed.
- Lead/support investigations, root cause analyses, and CAPA for deviations/events and equipment/process issues.
- Drive continuous improvement to enhance efficiency, compliance, and operational performance.
Qualifications:
- High School Diploma or equivalent.
- Experience leading/supporting manufacturing operations in a regulated environment; success supervising teams, maintaining schedules, and meeting quality/safety standards.
- Strong leadership and people development; manage operations while maintaining cGMP, safety, and quality.
Preferred:
- Bachelorβs in Biology, Chemistry, Engineering, Biomanufacturing, or related.
- 3β5+ years commercial GMP biomanufacturing (aseptic processing/cell culture/downstream purification/final formulation or fill/finish).
- Knowledge of USDA/FDA/EU GMP for biologics/sterile manufacturing.
- Experience with investigations, root cause analysis, and continuous improvement.
- Strong communication/coaching and cross-functional collaboration.
Benefits:
- Multiple relocation packages; 8-week parental leave; Annual bonus opportunity; Up to 6% 401(k) matching.
Application:
- If youβre excited but donβt meet every requirement, you are encouraged to apply.