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: The responsibilities may include but are not limited to the following activities:
- 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.
Requirements
- Bachelor's degree in Pharmaceutical Sciences, Biology, Chemical Engineering, Biochemical Engineering, Chemistry, or related discipline.
- Manager: 8+ years of experience in biopharmaceutical manufacturing, technical operations, or external manufacturing / quality.
- Senior Manager: 10+ years of relevant industry experience, including leadership of complex technology transfer and commercial manufacturing programs.
- Experience managing CMOs/CDMOs and external manufacturing networks.
- Strong understanding of biologics drug product manufacturing, aseptic processing, and lyophilization.
- Experience with technology transfer, process validation, PPQ, change management, deviation investigations, and CAPA development.
- Working knowledge of GMP regulations, quality systems, and regulatory requirements in the US and EU.
- Experience supporting clinical and commercial biologics products, including commercialization and product launch activities.
- Knowledge of analytical methods, stability programs, comparability assessments, and continued process verification preferred.
- Experience supporting regulatory inspections and audits.
- Cold-chain product experience (ULT and refrigerated storage/shipping) preferred.
- Excellent project management, communication, and stakeholder management skills.
- Strong problem-solving, risk management, and decision-making capabilities.
- Ability to influence cross-functional teams and external partners in a matrixed environment.
- Experience with global manufacturing networks, single-use technologies, and advanced aseptic processing platforms is desirable.
Benefits: Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy.
