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 Manager Manufacturing- Pancreatin.
The Manager is responsible for leading pancreatin manufacturing operations in compliance with current Good Manufacturing Practices (cGMP). This role ensures consistent execution and adherence to the manufacturing schedule, leading frontline teams, and maintaining high standards of quality, safety, and efficiency.
Responsibilities include:
Production Execution & Shift Oversight
- Manage daily activities of pancreatin manufacturing (wet processing), including scheduling and batch execution.
- Ensure production goals, timelines, and quality standards are consistently met.
- Monitor processes and resolve routine manufacturing issues.
- Direct and control all aspects of the operation including engineering, materials management, safety & environmental, manufacturing, training, validation and documentation.
- Produce high quality products at the lowest practical cost by optimizing the use of all resources (labor, materials, staff, utilities, capital).
- Develop and track goals, objectives, KPIs, capital plans, and budget for the facility.
- Ensure timely escalation of critical issues to the senior leadership team.
Quality, cGMP & Regulatory Compliance
- Ensure compliance with cGMP regulations (FDA, USDA, EPA, and OSHA) along with local and state requirements and foreign regulatory agencies, as applicable.
- Review and approve batch records, logbooks, and SOPs.
- Support deviation investigation, CAPAs, and change controls.
- Support and participate in internal and external audits and regulatory inspections.
- Foster a culture of safety, quality, and continuous improvement.
People leadership & Talent Development
- Supervise manufacturing staff, including supervisors and operators.
- Provide training, coaching, and performance feedback.
- Ensure proper onboarding and cGMP training compliance of new and existing employees.
- Establish clear expectations with employees regarding roles, goals, competencies, and core job responsibilities.
- Provide timely, balanced feedback on an ongoing basis and through the annual performance review process.
- Partner with employees in developing their growth plans and provide opportunities for employees to develop competencies.
Continuous Improvement & Corrective Action
- Identify and execute on opportunities to improve efficiency, reduce errors, and optimize workflows.
- Implement corrective and preventive actions to address recurring issues.
Cross Functional Collaboration & Customer Focus
- Ensure timely escalation of critical issues to the senior leadership team.
- Facilitate strong working relationships with Maintenance, Engineering, Quality, R&D, Finance, Customer Service & Sales, and Finance.
- Provide internal/external customer satisfaction by delivering dependable customer service and high-quality results by offering product improvements and by promptly following up on their complaints and/or concerns.
Job Requirements and Qualifications:
Education: Associate degree required; Bachelor’s degree or above preferred.
Experience: 5+ years required cGMP Manufacturing and 10+ years 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.
Skills Required
- Associate degree in relevant field
- Bachelor's degree
- 5+ years cGMP manufacturing experience
- Experience supervising manufacturing staff and frontline teams
- Experience with pancreatin manufacturing or wet processing
- Knowledge of cGMP and applicable regulations (FDA, USDA, EPA, OSHA)
- Experience reviewing/approving batch records, SOPs, logbooks, and documentation
- Experience supporting deviation investigations, CAPAs, and change controls
- Experience participating in internal/external audits and regulatory inspections
- Experience with production scheduling, KPIs, budgeting, and capital planning
- Demonstrated continuous improvement experience (process optimization, error reduction)
- Strong people leadership, training, and performance management skills
What We Do
Scientific Protein Laboratories is a leading global supplier of high-quality active pharmaceutical ingredients (APIs). Specializing in cGMP biopharmaceutical manufacturing, the company is among the largest commercial suppliers of Heparin Sodium USP, Pancreatin USP, and Pancrelipase USP. Based in Waunakee, Wisconsin, it serves the pharmaceutical, veterinary, and food industries globally.
