Director, Drug Product Development

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Requirements:

• Minimum of 12 years industry experience in drug product development and manufacturing.
• PhD in chemical engineering, biochemical engineering, chemistry, or a related field.
• Experience in biologics drug product process development and aseptic manufacturing.
• Experience managing drug product CDMOs including tech transfers and GMP operations.
• Proven track record of advancing assets from pre-clinical through IND and into late phase development.
• Extensive experience with cGMPs and knowledge of regulatory guidance.
• Experience with formulation development of recombinant proteins, including antibodies.
• Demonstrated ability to collaborate with cross-functional stakeholders.
• Excellent communication skills and willingness to travel up to 25%.

Responsibilities:

• Define and develop robust biologics drug product processes across the portfolio.
• Oversee drug product manufacturing including tech transfer, process development, and GMP manufacturing operations.
• Manage drug product CDMO adherence to deliverables, timelines, and performance.
• Support phase-appropriate strategies for drug product development and commercialization.
• Collaborate on drug product presentations and development of biologics co-formulations.
• Perform risk assessments using a QbD approach and identify opportunities for process improvement.
• Support formulation optimization for injectability and shelf-life.
• Collaborate with Quality team and external partners to resolve deviations and support investigations.
• Communicate findings and progress to stakeholders and support regulatory submissions.