Director / Senior Director, External Manufacturing Operations

The role

The Director / Senior Director, External Manufacturing Operations provides strategic leadership and oversight of the external manufacturing network. This person leads a team of professionals and manages supplier governance to meet supply requirements and business objectives.

What you will do

• Provide overall leadership for the External Manufacturing Operations function.
• Lead, coach, and develop a team of external manufacturing professionals.
• Ensure Virtual Management Teams operate effectively and collaboratively.
• Establish and maintain effective governance across the external manufacturing network.
• Develop strong cross-functional relationships internally.
• Provide senior leadership with updates regarding manufacturing performance and supply risks.
• Contribute to the development and execution of external manufacturing and supply network strategy.
• Support regulatory submission activities and regulatory inspections.
• Contribute to the continuous improvement of Technical Operations processes.

Required qualifications

• Bachelor’s degree in biotechnology, biology, chemistry, chemical engineering, pharmaceutical sciences, or a related field
• Minimum of 15 years of progressive experience in the biotechnology or pharmaceutical industry
• Significant responsibility for cGMP manufacturing operations and oversight of external manufacturing partners
• Demonstrated experience leading external manufacturing activities supporting clinical and commercial products
• Proven ability to build and manage strategic relationships with CDMOs
• Experience contributing to manufacturing network strategy, supply planning, technology transfer, commercial readiness, and risk management
• Strong leadership and people-management skills
• Demonstrated success managing complex external manufacturing organizations and supplier relationships
• Strong strategic thinking and business judgment
• Broad technical understanding of biotechnology/pharmaceutical manufacturing and process development
• Strong understanding of cGMP requirements and pharmaceutical Quality Systems
• Strong executive communication, influencing, and negotiation skills

Nice to have

• Advanced degree preferred
• Hands-on experience in process development and/or cGMP manufacturing is strongly preferred
• Experience with highly potent products is desirable

Benefits

• Medical, dental, and vision insurance coverage for employees and their dependents
• 100% company-paid medical premiums for employees
• 401(k) with employer match
• Employer-paid life insurance, short- and long-term disability insurance, and AD&D
• Paid time off
• Company holidays
• A week-long winter break between Christmas and New Years
• Paid parental leave

About the company

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. The company is advancing an innovative portfolio of therapeutics, including antibody-drug conjugates.