Production Services Supervisor

Salary Range: 105000 to 135000 (Currency: USD) (Pay period: per-year-salary)

Responsibilities

• Supervise daily third shift production activities and enforce safety, quality, environmental, and personnel policies.
• Monitor production schedules, allocate resources, and adjust plans to meet targets.
• Provide on-the-job training, coaching, and mentorship to manufacturing operators and production service associates.
• Troubleshoot production and equipment issues and escalate when required.
• Lead batch readiness activities including planning, material requests and transfers, and staging of materials and equipment.
• Ensure all activities comply with cGMP and FDA regulations and company procedures.
• Enforce SOPs and quality standards and review GMP records for completeness and accuracy daily.
• Identify and document deviations, assess product impact, and support corrective and preventive action proposals.
• Draft, revise, and review manufacturing SOPs, master batch records, specifications and other cGMP documentation.
• Drive process and workflow improvements and support MS&T initiatives.
• Represent the department on project teams and task forces and support continuous improvement activities.
• Maintain accurate production logs, batch records, and other manufacturing documentation.
• Maintain a clean, safe production environment and manage inventory levels for production readiness.
• Perform additional duties and flexible scheduling including weekend work as needed.

Qualifications

• Ability to work  7:30 PM - 4:00 AM shift, including weekend work as needed
• Bachelor’s degree in Engineering, Science, or related field or equivalent experience.
• Minimum 2 to 3 years of leadership experience in pharmaceutical manufacturing or a CDMO environment with hands-on manufacturing or validation experience.
• Strong knowledge of cGMP guidelines, FDA regulations, cleanrooms, HVAC systems, pharmaceutical processing, and plant equipment.
• Demonstrated experience with aseptic handling and biosafety cabinet operations.
• Proficiency with single-use technologies including tube welding and sealing.
• Excellent leadership, communication, problem-solving and organizational skills.
• Ability to work independently, prioritize multiple tasks, and lead cross-functional activities.
• Basic computer skills and competency with basic arithmetic.

Preferred Qualifications

• Degree with laboratory coursework in chemistry or biology.
• At least 2 years of cell culture experience in a cGMP biotech or pharmaceutical setting.
• Experience with mammalian cell culture processes and bioreactor operation.
• Upstream and downstream biologics experience.
• Strong technical and mechanical aptitude in bioprocessing.

Physical Requirements

• Ability to stand and walk for the length of the shift and sit or stand for extended periods.
• Frequent lifting or moving of objects up to 50 pounds.
• Ability to climb, balance, stoop, kneel, crouch, or crawl.
• Use of hands and fingers for handling and reaching.
• Visual acuity including near and far sight, color perception, peripheral vision, depth perception and focus.