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!
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.
We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live.
Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes.
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