Associate Director, Supply Chain and Logistics
Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our CytoDriveTM technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian’s lead program is currently in clinical development. We recently received our IND clearance from FDA to begin our first clinical trial for the treatment of patients with metastatic melanoma.
We’re proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our research team is based in the heart of Cambridge, MA, and our Technical Development, Manufacturing & Quality team is based in our brand new facility in Bedford, MA to support our growth. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.
We are looking for an individual to join us as Associate Director, Supply Chain and Logistics with a strong background in cell therapy clinical trial logistics for this brand-new role. You’ll work collaboratively with internal and external stakeholders to design and execute supply chain strategies and manage supply chain partners supporting our autologous cell therapy products. As part of our Technical Development, Manufacturing, and Quality department, you’ll be a vital part of a highly collaborative team working to achieve Obsidian’s vision by translating innovative science into medical breakthroughs for patients, starting with our lead program OBX-115, engineered to make TILs more effective for patients. This position is a hybrid role based in our Bedford, MA location.
This is a unique opportunity to be a contributor in a well-funded pre-clinical company with blue chip investors, field-leading advisors, best-in-class partners (BMS and Vertex), and an experienced team. You will help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.
- Design and execute our development phase supply chain plans including identifying/qualifying a network of vendors to support our strategy.
- Lead effort to establish oversight of shipment of patient material in collaboration with the CRO for future clinical trials and commercial requirements.
- Design and manage inventory tracking systems for critical materials to support overall clinical supply chain including coordination with Contract Development and Manufacturing Organizations (CDMOs).
- Be responsible for real time scheduling and tracking of patient material from tumor tissue harvest to shipments for infusion while maintaining Chain of Custody (CoC) and Chain of Identity (COI).
- Establish and maintain import permits (CDC, USDA) as required to support international shipments; establish Harmonized Tariff Codes for all materials crossing international borders.
- Develop/optimize cold-chain shipping configurations for patient samples and finished product and conduct/oversee required shipping qualification studies.
- Develop appropriate standard operating procedures related to supply chain processes and systems.
- Oversee Obsidian shipments including implementing and managing a process/system to maintain a shipping log, calendar, and records of physical and/or electronic files including pertinent documents from each completed shipment so that they can be accessed Obsidian colleagues as required.
- Identify areas for improvements to continuously streamline and improve the Logistics Process and overall patient treatment delivery timelines.
- Ensure overall cGMP compliance in collaboration with the Quality organization.
- Master’s Degree in Life Sciences, Supply Chain Management, or related discipline; or equivalent relevant experience.
- 8+ years of relevant experience in logistics, planning, or supply chain in a pharmaceutical or biotech company, especially in handling of cell therapy or other relevant products.
- Demonstrated experience managing distribution systems and/or working with third-party logistics providers for cell therapies or other relevant products.
- Extensive quality and compliance background in a clinical GMP operational environment.
- Strong knowledge of managing ultra-low temperature cold chains.
- Ability to think strategically - balance short term objectives and long term needs for building a robust supply chain to deliver complex treatments to patients.
- A highly collaborative working style - experience building healthy, productive, and high trust relationships within your function and with direct stakeholders, inviting and sharing ideas and feedback, and productively challenging own and others’ assumptions to generate new ideas and facilitate better outcomes.
- Self-motivation and a proven ability to work with general direction, exercise good judgement, and seek the information and support you need to meet objectives and timelines.
- Flexibility, ability to adapt to changes and priorities to fulfill our mission.
- Exceptional organizational skills to drive implementation of Supply Chain systems and practices to support Obsidian as we move from pre-clinical into clinical manufacturing.
- A desire and ability to work in a dynamic and entrepreneurial environment.
- Excellent oral and written communication skills.
- Ability to travel to partner sites or meetings, as required (estimated up to 15%).
- Strong understanding of and experience with international trade compliance laws and regulations including but not limited to, imports, exports, economic sanctions, Harmonization Tariff system (HTS), country of origin, boycott laws and Free Trade Agreements.
Obsidian is proud to be an equal opportunity employer, cultivating a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.