Manager, 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

The Company

Larimar Therapeutics Inc. (Larimar) is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich’s ataxia. Friedreich’s ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to genetic abnormality.

The company has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices.

The company’s strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team’s know-how to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.

If you are searching for a company where urgency, agility, and commitment to science win the day – we welcome you!

The Company

Larimar Therapeutics Inc. (Larimar) is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich’s ataxia. Friedreich’s ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to genetic abnormality.

The company has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices.

The company’s strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team’s know-how to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.

If you are searching for a company where urgency, agility, and commitment to science win the day – we welcome you!

Position Summary

Reporting to the Head of Drug Product, CMC Technical Operations, the Manager/Senior Manager, Drug Product Manufacturing is responsible for overseeing external manufacturing operations and technology transfer activities for lyophilized biologic drug products supporting clinical and commercial supply. This role serves as the primary technical and operational liaison with contract manufacturing organizations (CMOs/CDMOs), ensuring reliable supply, successful technology transfers, regulatory compliance, and continuous process improvement.

The successful candidate will provide technical leadership across drug product manufacturing, process validation, lifecycle management, and commercialization efforts while partnering closely with Technical Operations, MSAT, Quality, Regulatory Affairs, Supply Chain, Process Development, and external partners. Strong expertise in sterile manufacturing, lyophilization, biologics drug product development, technology transfer, and GMP operations is required.

Job Responsibilities

• Serve as the primary technical and operational lead for external manufacturing partners supporting aseptic filling, lyophilization, inspection, bulk packaging and labeling, and shipping.
• Manage CMO/CDMO relationships to ensure successful execution of manufacturing campaigns, technology transfers, and supply commitments.
• Lead technology transfer activities from process transfer through PPQ and commercialization, including transfer plans, risk assessments, gap analyses, and readiness reviews.
• Coordinate transfer of manufacturing processes, analytical methods, process knowledge, control strategies, and supporting documentation.
• Provide technical oversight of drug product manufacturing operations, including formulation, aseptic processing, lyophilization, inspection, and bulk packaging.
• Facilitate and /or review and approve manufacturing batch records, validation protocols and reports, change controls, investigations, CAPAs, and technical reports.
• Monitor manufacturing performance through KPIs, trend analyses, and operational reviews; identify risks and implement mitigation strategies.
• Evaluate manufacturing data to drive process robustness, continuous improvement, and operational excellence initiatives.
• Support engineering runs, PPQ campaigns, process validation, scale-up activities, and commercial launch readiness.
• Ensure manufacturing activities align with clinical and commercial supply requirements, program milestones, and launch timelines.
• Partner with internal and external Supply Chain, Program Management, Quality, Regulatory Affairs, MSAT, and Process Development to resolve technical and operational issues.
• Support regulatory submissions, inspections, client audits, and health authority interactions as a subject matter expert.
• Oversee CMOs/CDMOs and logistics providers to ensure compliant, reliable, and efficient supply chain operations.
• Ensure timely review, approval, and archival of manufacturing and quality documentation in accordance with company procedures.
• Communicate manufacturing, quality, and supply risks to project teams and senior leadership as appropriate.
• Maintain current knowledge of cGMP requirements, industry best practices, and applicable regulatory expectations.
• Travel up to 20% domestically and internationally.