Senior Manager, Biologic Drug Product Manufacturing

Larimar Therapeutics Inc.; Philadelphia (Philadelphia County); On-site; USD 150,000 - 190,000; Full time

Job summary

Larimar Therapeutics Inc. is seeking a Manager/Senior Manager, Drug Product Manufacturing to oversee external manufacturing and technology transfer for lyophilized biologic drug products supporting clinical and commercial supply.

Reporting to the Head of Drug Product, CMC Technical Operations, the role partners with MSAT, Quality, Regulatory Affairs, and Supply Chain to ensure reliable supply, regulatory compliance, and continuous process improvement.

Qualifications

• Experience leading external manufacturing for biologics.
• Strong knowledge of aseptic filling and lyophilization processes.
• Experience with technology transfer and PPQ (process performance qualification).
• Leadership in cross-functional teams and external CMOs/CDMOs.
• Understanding of regulatory expectations for commercial biologics.

Responsibilities

• Serve as the primary technical/operational lead for external manufacturing partners handling aseptic filling, lyophilization, inspection, bulk packaging, labeling and shipping.
• Manage CMO/CDMO relationships to ensure successful campaigns, tech transfers and supply commitments.
• Lead technology transfer from process transfer through PPQ and commercialization, including plans and readiness reviews.
• Coordinate transfer of processes, analytical methods, control strategies, and documentation.
• Provide technical oversight of drug product manufacturing, including formulation, aseptic processing, lyophilization and packaging.
• Review and approve batch records, validation protocols, change controls, investigations and CAPAs.
• Monitor manufacturing performance with KPIs and risk mitigation strategy implementation.
• Support process development, scale-up, validation, and commercial launch readiness.

Skills

Sterile manufacturing

Lyophilization

Biologics drug product development

Technology transfer

GMP operations

Regulatory compliance

Job description

Larimar Therapeutics Inc. is seeking a Manager/Senior Manager, Drug Product Manufacturing to oversee external manufacturing and technology transfer for lyophilized biologic drug products supporting clinical and commercial supply.

Reporting to the Head of Drug Product, CMC Technical Operations, the role partners with MSAT, Quality, Regulatory Affairs, and Supply Chain to ensure reliable supply, regulatory compliance, and continuous process improvement.