cGMP Manufacturing Supervisor - Night Shift
$88,800–$152,300 year
On-siteSt. Louis, Missouri, United States
Job Summary
Oversee cGMP manufacturing of Active Pharmaceutical Ingredients and manage production personnel, including a team of scientists and operators on rotating shifts. Provide guidance for production readiness, batch record review, equipment procurement, and employee scheduling while ensuring compliance with FDA regulations and cGMP guidelines. Lead root cause investigations for manufacturing deviations and coordinate cross-functional efforts with Quality Control, Engineering, and Materials Management. Manage capital for equipment improvements, balance the departmental budget, and create purchasing process orders. Maintain safety initiatives and ensure all tasks adhere to approved site procedures and protocols.
Required Qualifications
- Bachelor's Degree in Chemistry, Biology, Biochemistry, Chemical Engineering, or other Life Science disciplines
- 4+ years of manufacturing experience in a cGMP setting
- 1+ years of Management, Supervisory, or Lead experience
- 12 hour night shift (7:00pm - 7:30am) shifts with a 20% shift differential
- Minimum Qualifications
Desired Qualifications
- 3+ years of Management, Supervisory, or Lead experience in GxP environment
- Customer interfacing audit experience
- Knowledge of Six Sigma concepts/Lean Manufacturing or process improvement
- Familiarity with large scale cGMP process equipment, tangential flow, and chromatography automation
- Strong Microsoft Office experience for Manufacturing/Operating procedure writing, technical report generation, product tracking and trending data analysis and Operational Excellence reports
- Strong interpersonal skills and conflict resolution experience
- Advanced written and verbal communication skills
- Preferred Qualifications
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