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.
Responsibilities
- Lead technology transfers for sterile liquid and lyophilized biologics at CMOs.
- Design and oversee process development and characterization studies.
- Conduct developability 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.
Qualifications
- 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.
Senior Manager, Drug Product Development and Manufacturing in lexington at Unknown Company
This position is listed as full time and onsite.