Sr. Supervisor, Manufacturing (Night shift)

This position is on a 12-hour rotation, Red Night shift following a 2, 2, 3 schedule.

About the role

This role is responsible for the supervision of manufacturing clinical and commercial products under GMP conditions. The incumbent will supervise Manufacturing Associates on a Night shift, schedule shift tasks, ensure GMP compliance and safety, draft and review manufacturing documents, troubleshoot issues, and coordinate with other departments.

Responsibilities

• Supervises Manufacturing Associates by observing, instructing, coaching, leading, and developing staff.
• Identifies technical and non-technical development gaps and implements applicable plans and objectives.
• Performs manufacturing activities per cGMPs, ensuring staff are fully trained before performing activities.
• Schedules and directs daily manufacturing activities, communicating scheduling changes or issues to staff and management.
• Coordinates manufacturing activities with other departments, including production schedulers, quality control, materials management, manufacturing sciences, validation, facilities, process engineering, and quality assurance to ensure execution of PPRs, sampling, and validation.
• 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 identifies or 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 the facilities group.
• Coordinates and drafts revisions of batch-related documents, including batch records and SOPs.

Requirements

• Grounded understanding of the operating principles for Parenteral Filling and Drug Product Manufacturing.
• Solid knowledge of engineering and scientific principles associated with designated areas of responsibility.
• Understanding of primary design principles for the facility (e.g., air pressure differentials, material flow, people flow, utility systems).
• Basic understanding of the roles of other functional groups within the company, with particular knowledge of safety, GMP, and Human Performance principles.
• Ability to influence through effective communication of vision and purpose.

Skills

• Leadership: Champions correct behaviors, values-driven, sets and maintains culture.
• Organization: Maintains a supportive work environment and focuses on team development.
• Accountability: Consistency, clear understanding of roles, responsibilities, and expectations.
• Tactical: Allocates resources effectively depending on tasks at hand, according to incoming and outgoing batches or campaigns.
• Experience in a GMP pharmaceutical manufacturing facility.

Preferred Skills

• Technical/practical experience in Drug Product/Parenteral Filling.
• Competency in electronic systems (Oracle, CMMS, Trackwise, etc.).

Qualifications

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

Pay

The base compensation range for this role is $98,000.00 - $127,000.00. Base salary offered is determined through an analytical approach utilizing a combination of factors, including relevant skills and experience, job location, and internal equity. Regular employees are eligible to receive both short-term and long-term incentives, including cash bonuses and equity opportunities.

Benefits

• Medical, Dental, Vision, and Life insurance.
• Fitness and Wellness programs, including a fitness reimbursement.
• Short- and Long-Term Disability insurance.
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown (December 26 - December 31).
• Up to 12 company-paid holidays + 3 paid days off for Personal Significance.
• 80 hours of sick time per calendar year.
• Paid Maternity and Parental Leave benefit.
• 401(k) program participation with company-matched contributions.
• Employee stock purchase plan.
• Tuition reimbursement of up to $10,000 per calendar year.
• Employee Resource Groups participation.