About Us…
Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our cytoDRiVE® 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 for the treatment of patients with metastatic melanoma and non-small cell lung cancer.
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 Technical Operations team is based in our purpose built facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.
Our Opportunity...
We are looking for a highly motivated Director, Cell Orchestration and Logistics. As a key individual contributor within our Technical Operations team, you will oversee and coordinate the end to end product journey from patient starting material collection through final Investigational Product delivery, ensuring high reliability, cycle time performance, quality compliance, and cost effectiveness across Obsidian’s network of contract development and manufacturing organizations (CDMO’s), helping to drive the development of our first clinical stage autologous cell therapy program targeting solid tumors.
Partnering closely with Clinical Operations, CMC, Regulatory, Quality, and external vendors, you will drive Cell Orchestration system implementation, CDMO slot scheduling as well as support activities including SOP management, deviation investigation, change management according to current good manufacturing practices (cGMP). This position requires an individual proven record of establishing strong partnerships internally and externally to manage a complex autologous engineered cell therapy manufacturing network and deliver transformative medicine to patients.
You will be a vital part of a highly collaborative team working to achieve Obsidian’s vision by collaboratively translating innovative science into medical breakthroughs for patients starting with our lead program OBX-115, a novel engineered tumor-infiltrating lymphocyte (TIL) therapy.
This is a unique opportunity to be a contributor in a well-funded clinical company with blue chip investors, field-leading advisors, best-in-class partners, and an experienced team. You'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.
This is a hybrid role based out of our Bedford, MA location.
You Will...
- Define and lead the overall Cell Orchestration governance system, including strategic and daily management oversight to ensure the highest level of service level for patients through cycle time optimization and network allocation.
- Lead the implementation of a Cell Orchestration solution to support pivotal and commercial phases.
- Coordinate and execute all logistics requirements across all GMP and non GMP material transfers
- Oversee logistics partners’ performance with a focus on quality, reliability, and cost-effectiveness.
- Develop and manage the department’s annual logistics budget based on program goals and enrollment plans; partner with Finance to analyze variances and implement adjustments.
- Establish performance metrics, KPIs, and escalation pathways to ensure operational excellence and partner accountability
- Support BLA-enabling supply chain activities, including Chain of Identify and Chain of Custody strategies, shipping validation and temperature monitoring strategies.
- Proactively identify, assess, and mitigate operational, quality, and organizational risks; escalate key risks and issues.
- Drive continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability
- Partner with Technical Operations & Quality, Regulatory and Finance to ensure full compliance with GxP, GMP, and other regulatory requirements.
- Together with the VP, Global Supply Chain, identify opportunities to leverage AI capabilities of current systems in the near term, and a mid-to-long term strategy to leverage AI into cell orchestration and logistics as our programs advance.
You Bring...
Core Qualifications
- Bachelor's degree in Supply Chain Management, Business, Engineering, or related discipline with 12+ years of progressive experience within the biopharma industry, including experience in cell & gene therapy.
- Strong knowledge of and/or direct experience in autologous cell therapy focused on Patient Supply management.
- Extensive quality and compliance background in a clinical GMP operational environment, including a minimum of 5+ years in a commercial or clinical GMP environment and 3 years prior experience in Cell and Gene Therapy Cold Chain Logistics.
- Extensive experience in Cell Orchestration, supply chain planning, ERP system, capacity modeling, supply network strategy, and optimization.
- Expertise and track record in manufacturing and supply chain execution and oversight.
- Expertise on just in time logistics.
- Solid knowledge of regulatory requirements, regulatory guidance, including pharmaceutical GMPs and ICH guidance.
- Cultivates collaboration, transparency, and accountability within and across teams; recognizes success requires interdisciplinary thinking and partnership.
- Inspires confidence, credibility, and trust internally and externally; recognized for high integrity.
- Operates with urgency. Adept at building buy-in and driving alignment within and across teams, senior leadership, and external partners.
- Exceptional communication skills in verbal, written, and visual formats, and adapted to the audience.
- Tenacious and resilient – has navigated significant challenges (scientific and business) and is not easily daunted.
- Excellent organizational skills; able to manage multiple tasks of varying degrees of complexity in parallel.
- Remains calm under pressure and leads others through complex situations.
- Seeks the data, information, and support needed (internally and externally) to make efficient and informed decisions and meet objectives.
- Builds followership by being transparent, persuasive, excited about the work, and willing to work hard together to get the job done.
- Continuous learner – actively follows innovations in area of expertise, fosters innovative thinking, and adopts novel approaches that are fit for purpose.
- Reflective and self-aware; leads by example with a growth mindset.
Bonus Qualifications...
- Strong knowledge of managing temperature controlled cold chains including 2-8C, -80C, and LN2 preferred; including prior experience in managing such shipments in collaboration with logistics partners.
- Familiarity with AI-powered supply chain tools.
- Ability to translate complex supply chain challenges into AI/ML use cases.
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.
