Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as a Manufacturing Supervisor.
Our Manufacturing Supervisor is responsible for overseeing daily GMP manufacturing operations to ensure production activities are executed safely, efficiently, and in compliance with cGMP requirements, SOPs, and company policies. This role provides direct leadership to manufacturing personnel, maintains documentation integrity, drives production performance, and serves as the primary escalation point for shift operations. The Manufacturing Supervisor promotes a culture of safety, quality, accountability, and continuous improvement while ensuring products are manufactured according to established specifications and regulatory requirements.
Responsibilities:
- Ensures timely and accurate execution of manufacturing instructions.
- Monitors ongoing operations and address routine issues in real time.
- Reviews batch records, logbooks, and documentation in real time for completeness and accuracy.
- Enforces proper documentation practices (ALCOA+ principles).
- Promotes a right first time mentality to reduce errors that are within the team’s control.
- Escalates deviations, non-conformances, and safety concerns in a timely manner, as needed.
- Ensures staff are properly trained and qualified to execute assigned tasks.
- Maintains shift coverage, including scheduling and attendance tracking. Create a finite schedule for the assigned team.
- Promotes a strong culture of safety and quality on the floor.
- Ensures compliance and proper use of PPE and adherence to manufacturing gowning procedures.
- Participates in investigations related to deviations, incidents, or out of specification results in taking appropriate immediate actions and escalation, as needed.
- Assists with troubleshooting equipment and process issues.
- Identifies opportunities for process improvement and communicate them to management. Support or lead actions to implement process improvements.
- Serves as the primary point of contact for assigned shift operations.
- Communicates production status, issues, and leads the shift change meetings.
- Collaborates with Quality, Maintenance, Warehouse, and other teams as necessary
- Ensures the proper systems and resources are in place to meet production schedules on time and that product is manufactured to specification and in accordance with SOP's and cGMP's, company policies and safety procedures.
- Supervises hourly operators in proper operating techniques and procedures.
- Coaches, trains, develops, disciplines and recognizes employees, including performance reviews.
- Develops information and compiles reports concerning scheduling, production goals, equipment and maintenance problems and other studies and/or reports as needed.
- Assists in developing production schedules; confers with department managers and Department Head to coordinate the scheduling of operations to achieve required deadlines.
- Supervises, coordinates, and controls the day-to-day production and operating activities to ensure optimum utilization of personnel, materials and equipment.
- Interacts without outside vendors and senior management needed.
- Participates in multi-functional teams as needed.
- ·Capable of interpreting process and instrument diagrams (P&ID’s).
Job Requirements and Qualifications
Required:
- Associate degree in Life Sciences, Engineering, Manufacturing, Operations, or a related technical field.
- Equivalent combination of education and relevant manufacturing leadership experience may be considered.
- Minimum of 5 years’ manufacturing experience in a regulated pharmaceutical, biotechnology, medical device, or other GMP-regulated environment.
- Minimum of 2 years’ direct supervisory or team leadership experience in a manufacturing setting.
- Experience overseeing batch manufacturing operations and production personnel.
- Ability to work 3rd shift (4PM to 4AM), every Wed., Thurs., & every other weekend.
Preferred:
- Bachelor's degree in Life Sciences, Engineering, Manufacturing, Operations, or a related technical field.
- Experience supporting investigations, deviations, CAPAs, and quality systems preferred.
WHY JOIN SPL?
Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential.
Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more!
SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.
SPL, a Hepalink Company, creates the Active Pharmaceutical Ingredients Heparin Sodium USP, Pancreatin USP, and Pancrelipase USP. We serve the pharmaceutical, veterinary, and food industries globally. We specialize in cGMP biopharmaceutical manufacturing. Within the still-young biopharmaceutical industry, we are among a small group of companies with an established track record in efficient process development, analytical testing, quality assurance, and regulatory support required to provide our customers with cGMP compliant APIs at all phases of clinical development, straight through to commercial launch.
