This job is closed
Applications are no longer available for this announcement. Explore current related opportunities below.
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.
#J-18808-Ljbffr
Worksite address
lexington, MA, 02173, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.