Sr. Supervisor, Manufacturing

Role Summary

Sr. Supervisor, Manufacturing. This role is responsible for the supervision of manufacturing of clinical and commercial products under GMP conditions. The incumbent will supervise Manufacturing Associates on a Night shift; schedules shift tasks; ensures GMP compliance and safety; drafts and reviews manufacturing documents; troubleshoots; and coordinates with other departments.

Responsibilities

• Supervises Manufacturing Associates – observing/instructing, coaching, leading and developing staff. Identifies technical/non-technical development gaps and implements applicable plans/objectives.
• Performs manufacturing activities per cGMPs, ensuring that reports are fully trained on a given activity prior to performing the activity.
• Schedules and directs daily manufacturing activities, timely communicating scheduling changes/issues to staff and management.
• Coordinates manufacturing activities with other departments. This includes providing updates to production schedulers, and working closely with quality control, materials management, manufacturing sciences, validation, facilities, process engineering, and quality assurance, etc. to ensure execution of PPRs, sampling, validation, etc.
• Reviews and approves batch related documents, ensuring the proper cGMP documentation practices are followed.
• Trains manufacturing associates on process activities, including Safety requirements and cGMP requirements. Reviews safety records and identifies/implements corrective measures.
• Supervises validation activities, ensuring proper and timely execution of validation protocols required in respective areas.
• Troubleshoots operational and equipment problems and makes recommendations. Also coordinates emergency repairs, changeovers, and preventative maintenance activities with the facilities group.
• Coordinates and drafts revisions of batch related documents, including batch records and SOPs.

Qualifications

• Required: Experience in a GMP pharmaceutical manufacturing facility
• Required: Bachelor’s Degree (STEM strongly preferred) + 4 years of transferrable experience; Associates’ Degree + 6 years; High School Diploma + 8 years
• Preferred: Technical/practical experience in Purification Manufacturing
• Preferred: Competency in electronic systems (Oracle, CMMS, Trackwise, etc.)

Skills

• Leadership (champions the correct behaviors, values driven, sets & maintains culture)
• Organization (maintaining a supportive work environment, team-development)
• Accountability (consistency, clear understanding of roles, responsibilities, expectations)
• Tactical (can allocate resources effectively depending on tasks at hand, according to incoming and outgoing batches/campaigns)
• Experience in a GMP pharmaceutical manufacturing facility

Education

• Bachelor’s Degree (STEM strongly preferred) + 4 years of transferrable experience
• Associates’ Degree + 6 years of transferrable experience
• High School Diploma (or equivalent certificate) + 8 years of transferrable experience