Manufacturing Supervisor

POSITION SUMMARY:

Under general direction, the Manufacturing Supervisor is responsible for the day-to-day leadership, supervision, and execution of GMP-compliant fill/finish manufacturing operations. This position provides direct oversight of manufacturing personnel and activities associated with formulation, equipment setup, aseptic processing, filling, component preparation, and associated manufacturing support activities.

The Manufacturing Supervisor ensures manufacturing operations are performed safely, efficiently, and in accordance with approved SOPs, batch records, applicable cGMP requirements, company policies, client requirements, and regulatory expectations.

The Supervisor is responsible for planning and coordinating daily manufacturing activities, assigning personnel, monitoring production performance, ensuring appropriate staffing and training, and escalating quality, safety, equipment, material, and scheduling issues in a timely manner.

The position serves as a key liaison between Manufacturing, Quality Assurance, Quality Control, Engineering, Supply Chain, Project Management, and other departments to ensure production activities are executed successfully and on schedule.

Other responsibilities include monitoring, troubleshooting, maintaining and validation of equipment required for related manufacturing operations including support systems, as applicable.

PRINCIPAL DUTIES:

• Strong knowledge of GMP procedures and requirements, as directly related to the position.
• Supervise daily fill/finish manufacturing activities, including formulation, equipment setup, line clearance, component preparation, aseptic processing, filling, and associated manufacturing operations.
• Plan, prioritize, and assign daily work based on production schedules, project requirements, employee qualifications, equipment availability, material readiness, and facility constraints.
• Ability to set-up, maintain and perform various manufacturing related activities as required for a GMP compliant Fill/Finish operation.
• Develop, edit, and review SOPs and Batch Records for all manufacturing related activities as required for a GMP compliant Fill/Finish operation.
• Identify, document, and escalate deviations, procedural discrepancies, equipment issues, material discrepancies, safety concerns, and other events that may affect product quality, personnel safety, compliance, or production schedules.
• Assist in executing validation protocols and or machinability studies.
• Participate in production planning and scheduling activities to ensure manufacturing resources, personnel, equipment, and materials are available to support project commitments.
• Ensure batch records and logbooks are completed accurately, legibly, and in a timely manner, with errors minimized and corrected in accordance with applicable GDP and GMP requirements.
• Perform various manufacturing duties according to GMP guidelines and initiate appropriate documentation as required including all forms, logs, batch records, etc., according to the applicable SOPs.
• Support the timely and accurate recording of material issuance, usage, returns, transfers, and inventory adjustments, as authorized and applicable to the manufacturing process.
• Ability to perform technical evaluation of manufacturing related information and provide management with status reports including information required for decision-making purposes.
• Written and oral skills at a level commensurate for interaction with staff, vendors, and clients, as necessary.
• Demonstrated proficiency with computer systems and software applications used to support pharmaceutical manufacturing operations, including the Microsoft Office Suite (e.g., Excel, Word, Outlook, and PowerPoint), ERP systems such as NetSuite, and manufacturing equipment Human-Machine Interfaces (HMIs).
• Ability to work flexible hours, including overtime or adjusted schedules, to support production requirements when necessary.
• Performs other related duties and responsibilities as assigned.

EDUCATION & REQUIREMENTS:

• Education: A Bachelor’s degree in Chemistry, Pharmacy, Engineering, Life Sciences, or a related field is preferred. An equivalent combination of education, technical training, and commensurate relevant work experience in pharmaceutical drug product manufacturing may be considered in lieu of a degree.
• Experience: 2–6+ years in a regulated pharmaceutical, biotech, or medical device environment.
• Demonstrated hands-on experience with pharmaceutical drug product fill/finish manufacturing lines, including vial, prefilled syringe, and cartridge filling operations preferred.
• Leadership: Demonstrated experience leading teams or acting as a mentor, with 1–2+ years of prior supervisory experience highly preferred