Sr. Supervisor, Manufacturing

Role Summary

Sr. Supervisor, Manufacturing responsible for supervising the manufacture of clinical and commercial products under GMP conditions, overseeing Night shift operations, drafting and reviewing manufacturing documents, troubleshooting, and coordinating with other departments.

Responsibilities

• Supervises Manufacturing Associates ‚Äì observing/instructing, coaching, leading and developing staff. Identifies development gaps and implements plans/objectives.
• Performs manufacturing activities per cGMPs, ensuring reports are trained on the activity prior to performing it.
• Schedules and directs daily manufacturing activities, communicating scheduling changes/issues to staff and management.
• Coordinates manufacturing activities with other departments to ensure execution of PPRs, sampling, validation, etc.
• Reviews and approves batch-related documents, ensuring proper cGMP documentation practices.
• Trains manufacturing associates on process activities, including Safety and cGMP requirements; reviews safety records and implements corrective measures.
• Supervises validation activities, ensuring proper and timely execution of validation protocols.
• Troubleshoots operational and equipment problems and coordinates emergency repairs, changeovers, and preventative maintenance with facilities.
• Coordinates and drafts revisions of batch-related documents, including batch records and SOPs.

Qualifications

• Experience in a GMP pharmaceutical manufacturing facility
• Bachelor‚Äôs Degree (STEM strongly preferred) + 4 years of transferrable experience
• Associates‚Äô Degree + 6 years of transferrable experience
• High School Diploma (or equivalent) + 8 years of transferrable experience

Preferred Skills

• Technical/practical experience in Purification Manufacturing
• Competency in electronic systems (Oracle, CMMS, Trackwise, etc.)

Skills

• Leadership
• Organization
• Accountability
• Tactical resource allocation
• Understanding of GMP and safety principles