Manufacturing Supervisor - Night Shift
Takeda
4 months ago
On-site
Brooklyn Park, MN
$89,900 - $141,240 USD yearly
Operations
Manufacturing Supervisor (cGMP Biologics)
Shift: 5:45 PM – 6:15 AM on a 2-2-3 schedule.
Responsibilities:
- Oversee personnel and daily manufacturing activities for assigned area in a cGMP biologics manufacturing facility.
- Ensure Manufacturing Associates perform tasks in a cGMP-compliant and safe manner; ensure adherence to the (daily) manufacturing schedule.
- Ensure tasks are performed according to SOPs.
- Coach, train, and develop employees.
- Perform/assist processing steps and/or manufacturing support by monitoring process parameters in batch records and control systems.
- Document/record cGMP data and information (e.g., batch records, SAP data entry, equipment logbooks).
- Review manufacturing documentation daily (e.g., BPRs, logbooks).
- Coordinate Facilities, Metrology, Validation, Product Development, and other non-routine activities with the manufacturing schedule.
- Provide oversight of support groups working with manufacturing systems.
- Provide leadership during troubleshooting of equipment, operations, and processes.
- May revise/create procedures and documents.
- Support/complete deviation investigations.
- Conduct annual performance reviews and set/monitor annual goals for direct reports.
- Lead/support deviation initiation, investigations, and closure; participate in cross-functional teams; support technical transfers.
- Analyze staffing needs and make staffing adjustments/recommendations.
- Complete mandatory training within required timeframe.
Qualifications (What you bring):
- Bachelor’s degree (scientific or engineering preferred) and 4+ years of GMP experience; or
- Associate degree (scientific or engineering preferred) and 6+ years of GMP experience; or
- High school diploma or GED and 8+ years of GMP experience.
- Previous supervisory experience (highly preferred).
- Biotech or pharmaceutical experience (preferred).
- Demonstrated application of cGMPs and Good Documentation Practices (GDP).
- Advanced understanding of cGMP biotech/pharmaceutical operations (plus).
- Proficient in operation and complex troubleshooting of multiple manufacturing areas (e.g., downstream, upstream, media buffer).
- Some knowledge of non-manufacturing functions (QC, Regulatory, QA, and/or Materials Management).
- Advanced understanding of the scientific theory of biologics manufacturing/biotechnology processing.
- Equipment understanding (function and application).
- Ability to analyze department performance and implement improvement strategies.
- Ability to train and develop direct reports.
- Detail-oriented; strong team orientation in a fast-paced environment.
- Excellent written and oral communication skills.
- Proficient in MS Office and related PC skills.
Application instructions:
- Apply via the “Apply” button (employment application process will commence).
Shift: 5:45 PM – 6:15 AM on a 2-2-3 schedule.
Responsibilities:
- Oversee personnel and daily manufacturing activities for assigned area in a cGMP biologics manufacturing facility.
- Ensure Manufacturing Associates perform tasks in a cGMP-compliant and safe manner; ensure adherence to the (daily) manufacturing schedule.
- Ensure tasks are performed according to SOPs.
- Coach, train, and develop employees.
- Perform/assist processing steps and/or manufacturing support by monitoring process parameters in batch records and control systems.
- Document/record cGMP data and information (e.g., batch records, SAP data entry, equipment logbooks).
- Review manufacturing documentation daily (e.g., BPRs, logbooks).
- Coordinate Facilities, Metrology, Validation, Product Development, and other non-routine activities with the manufacturing schedule.
- Provide oversight of support groups working with manufacturing systems.
- Provide leadership during troubleshooting of equipment, operations, and processes.
- May revise/create procedures and documents.
- Support/complete deviation investigations.
- Conduct annual performance reviews and set/monitor annual goals for direct reports.
- Lead/support deviation initiation, investigations, and closure; participate in cross-functional teams; support technical transfers.
- Analyze staffing needs and make staffing adjustments/recommendations.
- Complete mandatory training within required timeframe.
Qualifications (What you bring):
- Bachelor’s degree (scientific or engineering preferred) and 4+ years of GMP experience; or
- Associate degree (scientific or engineering preferred) and 6+ years of GMP experience; or
- High school diploma or GED and 8+ years of GMP experience.
- Previous supervisory experience (highly preferred).
- Biotech or pharmaceutical experience (preferred).
- Demonstrated application of cGMPs and Good Documentation Practices (GDP).
- Advanced understanding of cGMP biotech/pharmaceutical operations (plus).
- Proficient in operation and complex troubleshooting of multiple manufacturing areas (e.g., downstream, upstream, media buffer).
- Some knowledge of non-manufacturing functions (QC, Regulatory, QA, and/or Materials Management).
- Advanced understanding of the scientific theory of biologics manufacturing/biotechnology processing.
- Equipment understanding (function and application).
- Ability to analyze department performance and implement improvement strategies.
- Ability to train and develop direct reports.
- Detail-oriented; strong team orientation in a fast-paced environment.
- Excellent written and oral communication skills.
- Proficient in MS Office and related PC skills.
Application instructions:
- Apply via the “Apply” button (employment application process will commence).