Supervisor Manufacturing- Pancreatin

JOB SUMMARY

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.

The Manufacturing Supervisor is responsible for the oversight of daily GMP manufacturing operations, ensuring production activities are executed in a safe, compliant, and efficient manner. This role provides direct supervision of manufacturing personnel, ensures strict adherence to cGMP requirements, maintains real-time documentation integrity, and serves as the primary operational escalation point for the assigned shift.

Schedule:

• 3rd shift (4PM to 4AM), every Wed., Thurs., & every other weekend

Responsibilities include:

Production Execution & Shift Oversight

• Ability to understand and operate process equipment.
• Ensures timely and accurate execution of manufacturing instructions.
• Monitor ongoing operations and address routine issues in real time.
• Serve as the primary point of contact for the shift activities. 
• Communicate production status, issues, and lead the shift change meetings.
• 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.
• Monitors and controls production schedules and activities to ensure meeting of departmental performance objectives and budgets.
• Supervises, coordinates, and controls the day-to-day production and operating activities to ensure optimum utilization of personnel, materials and equipment.
• Ensures adequate resources are available to manufacture product (equipment, supplies, and labor).
• 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.

Quality, Documentation & cGMP Compliance

• Review batch records, logbooks, and documentation in real time for completeness and accuracy.
• Enforce proper documentation practices (ALCOA+ principles).
• Promote a right first-time mentality to reduce errors within the team’s control.
• Escalate deviations, non-conformances, and safety concerns in a timely manner, as needed.
• Participate in investigations related to deviations, incidents, or out of specification results including taking appropriate immediate actions and escalation, as needed.
• Maintains compliance with company policies, SOP's, cGMP's, safety standards and housekeeping practices.
• Support and participate in internal and external audits and regulatory inspections and audit readiness activities.

Safety & Environmental Compliance

• Promote a strong culture of safety and quality on the floor.
• Ensure compliance with and proper use of PPE and adherence to manufacturing gowning procedures.
• Escalate safety concerns and incidents in a timely manner as needed.

People Leadership & Workforce Management

• Directly supervise operators and ensure staff are properly trained and qualified to execute assigned tasks.
• Maintain shift coverage, including scheduling and attendance tracking. Create the finite schedule for the assigned team.
• Supervises hourly operators in proper operating techniques and procedures.
• Coaches, trains, develops, disciplines and recognizes employees, including conducting performance reviews.
•  Develops department employees through establishing objectives, communication of rules and policies while building employee morale and motivation.

Troubleshooting, Investigations & Continuous Improvement

• Assist with troubleshooting equipment and process issues.
• Investigates and resolves problems, identifies root cause, and clearly communicates to senior management.
• Identify opportunities for process improvement and communicate them to management.
• Support or lead actions to implement process improvements.
• Advises department management on matters relating to daily operations and makes recommendations for process improvements.

Cross Functional Collaboration & Reporting

• Collaborate with Quality, Maintenance, Warehouse, and other teams as necessary.
• Participate in multi-functional teams as needed.
• Interacts without outside vendors and senior management as needed.

• Process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements.

Job Requirements and Qualifications:

Education: Associate degree required; Bachelor’s degree or above preferred. Experience in lieu of education may be considered.

Experience: 3+ years required cGMP Manufacturing and 1+ years leadership 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.