Senior Manager, Drug Product Development and Manufacturing

Meet Life Sciences; Lexington (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Meet Life Sciences in Lexington, MA seeks a Senior Manager to lead drug product development and technology transfer for late-stage and commercial sterile biologics. You will partner with cross-functional teams and external CMOs to advance formulation, process development, technology transfer, and manufacturing strategy for liquid and lyophilized products.

The role requires managing CMOs for sterile fill/finish, overseeing development studies, and ensuring robust CMC documentation and project

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.

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.

Skills

Biologics formulation

Drug product process development

CMO management

Education

PhD/MS in pharmaceutical sciences

BS in pharmaceutical sciences or related field

Job description

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.