Manager Manufacturing- Pancreatin

Scientific Protein Laboratories•Waunakee, WI

92d•Onsite

About The Position

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.

Requirements

5+ years required cGMP Manufacturing
Associate degree required

Nice To Haves

10+ years preferred cGMP Manufacturing
Bachelor’s degree or above preferred

Responsibilities

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.
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.
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.
Identify and execute on opportunities to improve efficiency, reduce errors, and optimize workflows.
Implement corrective and preventive actions to address recurring issues.
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.