Senior Manager, Drug Product Development and Manufacturing

Seeking a Senior Manager to lead drug product development and technology transfer activities for late-phase and commercial sterile biologic products
. This role will partner with cross-functional teams and external CMOs to support formulation and process development, technology transfer, and manufacturing strategy for liquid and lyophilized drug products.

• Lead technology transfers for sterile liquid and lyophilized biologics at CMOs.
• Design and oversee process development and characterization studies.
• Conduct develop ability and manufacturability assessments for early-phase candidates.
• Author and review protocols, reports, and CMC documentation.
• Manage CRO/CMO relationships and drive project milestones.
• Communicate project updates, risks, findings, and recommendations to stakeholders.
• Partner with Discovery and cross-functional teams to support candidate selection and drug product strategy.

• PhD/MS with 5+ years or BS with 10+ years of experience in biologics formulation and drug product process development.
• Degree in pharmaceutical sciences, biochemistry, bioengineering, chemistry, or related field.
• Experience with monoclonal antibodies or other biologic drug products, including sterile liquid and or lyophilized formulations.
• Proven experience managing CMOs for technology transfer, process development, and sterile fill/finish manufacturing.