Director of Drug Product Manufacturing

Biologics Validation & Parenteral Manufacturing Leadership

Job Summary

The Director of Manufacturing is a responsible for leading all aspects of biologics validation and parenteral manufacturing operations. Reporting directly to the Chief Technical Operations, this role oversees supply chain management, Contract Development and Manufacturing Organization (CDMO) partnerships, GMP manufacturing and personnel development to ensure the highest standards of quality, compliance, and operational efficiency.

Key Responsibilities

· Biologics Validation: Direct and refine validation strategies for biologic products, ensuring compliance with regulatory standards and industry best practices.

· Parenteral Manufacturing: Oversee the full spectrum of parenteral manufacturing processes, including aseptic techniques, sterile filtration, and fill-finish operations, driving continuous improvement and operational excellence.

· Supply Chain Management: Lead end-to-end supply chain activities, including procurement, inventory control, and logistics, to support reliable and cost-effective manufacturing output.

· CDMO Oversight: Manage relationships with CDMOs, ensuring contract compliance, quality deliverables, and alignment with organizational goals.

· Personnel Leadership: Develop and mentor a high-performing manufacturing team, fostering a culture of accountability, safety, and professional growth.

· Operational Leadership: Provide hands-on guidance and decision-making to resolve technical challenges, optimize resources, and meet production targets.

Qualifications

· Bachelor’s degree in engineering, life sciences, or a related field; advanced degree preferred.

· Minimum 15 years of progressive experience in biologics parenteral manufacturing validation, including leadership roles.

· Demonstrated expertise in supply chain management and CDMO oversight

· Proven track record of building and leading cross-functional teams.

Preferred Skills

· Strategic leadership with a hands-on operational approach.

· Excellent communication and stakeholder management skills.

· Strong analytical and problem-solving abilities.

· Experience navigating complex regulatory frameworks.

This is an onsite position in Rochester, MN.