Sr. Supervisor, Manufacturing

Role Summary

Sr. Supervisor, Manufacturing. This role supervises the manufacturing of clinical and commercial products under GMP conditions, overseeing Night shift operations, drafting and reviewing manufacturing documents, troubleshooting, and coordinating with multiple departments on a 12-hour Night shift (2-2-3 schedule).

Responsibilities

• Supervises Manufacturing Associates – observing/instructing, coaching, leading and developing staff. Identifies development gaps and implements plans/objectives.
• Performs manufacturing activities per cGMPs, ensuring reporters are fully trained prior to performing the activity.
• Schedules and directs daily manufacturing activities, communicating scheduling changes/issues to staff and management.
• Coordinates manufacturing activities with other departments, providing updates to production schedulers and working with quality control, materials management, manufacturing sciences, validation, facilities, process engineering, and quality assurance to ensure execution of PPRs, sampling, validation, etc.
• Reviews and approves batch-related documents, ensuring proper cGMP documentation practices are followed.
• 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, coordinates emergency repairs, changeovers, and preventative maintenance with facilities.
• Coordinates and drafts revisions of batch-related documents, including batch records and SOPs.

Qualifications

• Required: Bachelor’s Degree (STEM strongly preferred) + 4 years transferrable experience; or Associates’ Degree + 6 years transferrable experience; or High School Diploma + 8 years transferrable experience.
• Experience in a GMP pharmaceutical manufacturing facility.

Skills

• Leadership: champions correct behaviors, values-driven, sets and maintains culture.
• Organization: supports team development and a productive work environment.
• Accountability: clarity on roles, responsibilities, and expectations.
• Tactical: resource allocation aligned with batches/campaigns.
• Preferred: Technical/practical experience in Purification Manufacturing; competency with Oracle, CMMS, Trackwise, etc.

Education

• Bachelor’s Degree (STEM strongly preferred) or equivalent transferrable experience as listed above.