Description

The Company:

Larimar Therapeutics Inc. 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 a genetic abnormality.

The company 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.

Position Summary:

The Associate Director/Director of Commercial Supply Chain is responsible for the end-to-end design, launch readiness, and ongoing execution of the commercial supply chain supporting a recombinant fusion protein therapy for the treatment of Friedreich’s ataxia. The product is a high-volume, daily subcutaneous therapy supplied as a lyophilized drug product requiring reconstitution with sterile water for injection.

This leader ensures uninterrupted product availability, regulatory compliance, and operational excellence across manufacturing, packaging, distribution, and commercial fulfillment. The role partners closely with Drug Product Manufacturing, Clinical Supply Chain, Commercial (Marketing, Market Access, and Sales), Quality Assurance, Finance, and Medical Affairs to deliver a seamless patient experience that prevents missed doses and supports successful commercialization.

The initial commercialization focus will be a United States launch, with concurrent strategic planning alongside commercial and distribution partners to enable phased ex-U.S. expansion. The Director will ensure global scalability of supply chain design, regulatory readiness, and distribution infrastructure to support future international market entry.

Job Responsibilities:

The responsibilities may include but are not limited to the following activities:

• Lead the development and execution of the commercial supply chain strategy supporting U.S. launch readiness and long-term lifecycle management while enabling scalable expansion into ex-U.S. markets.
• Translate demand forecasts into manufacturing, packaging, inventory, and distribution plans that ensure uninterrupted supply for a high-volume daily therapy.
• Oversee commercial readiness of drug product manufacturing, packaging, labeling, and distribution operations.
• Lead selection, qualification, and governance of CMOs, contract packaging organizations, and logistics partners.
• Provide expert oversight of shipping and transit validation programs, including temperature control, distribution lane qualification, and last-mile delivery.
• Establish and maintain product serialization and track-and-trace systems compliant with global regulatory requirements.
• Direct validation and lifecycle management of commercial packaging operations, including line qualification, process validation, and performance monitoring.
• Ensure effective vendor governance including approval of protocols, reports, quality documentation, and change controls.
• Partner with Quality Assurance to support deviations, investigations, CAPAs, and inspection readiness across the supply network.
• Coordinate cross-functional alignment with Drug Product Manufacturing, Clinical Supply Chain, Marketing, Market Access, Sales, Finance, Medical Affairs, and Quality.
• Lead inventory strategy, supply planning, and risk mitigation to prevent therapy interruption and missed patient doses.
• Implement operational metrics, dashboards, and continuous improvement initiatives across packaging, logistics, and distribution.

Additional Functional Scope:

The role is expected to provide leadership or deep expertise in the following areas:

• Cold chain and temperature-controlled logistics strategy
• Secondary packaging configuration and human-factors considerations for reconstitution
• Combination-product or administration-system integration (if applicable)
• Artwork management and labeling compliance
• Global trade compliance and import/export controls
• Demand planning, S&OP, and lifecycle inventory management
• Returns, complaints, and product disposition processes
• Cost-to-serve optimization and gross-to-net awareness
• Digital supply chain visibility and traceability systems
• Sustainability and waste-reduction initiatives in packaging and distribution

Qualifications:

Education

• Bachelor’s degree in Supply Chain, Engineering, Life Sciences, or related field required.
• Advanced degree (MBA, MS, or equivalent) preferred.

Experience

• 10+ years of progressive experience in biopharmaceutical supply chain, with significant commercial-stage responsibility.
• Demonstrated leadership in launch readiness for sterile injectable or biologic therapies.
• Proven expertise in the following areas: Shipping and transit validation; Product serialization and track-and-trace compliance; Commercial packaging operations oversight and validation; Vendor governance across CMOs, CPOs, and logistics providers
• Experience supporting high-volume or chronic-use therapies strongly preferred.
• Prior responsibility for global distribution and specialty pharmacy channels desirable.

Technical & Leadership Competencies

• Deep knowledge of cGMP, GDP, and regulatory expectations for biologics commercialization.
• Strong risk-management and problem-solving capabilities in complex supply environments.
• Financial acumen related to inventory, cost management, and commercial forecasting.
• Excellent cross-functional leadership, communication, and executive-presentation skills.
• Ability to operate effectively in a fast-paced, launch-driven environment with evolving priorities.

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