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Associate Director, External Manufacturing
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 preclinical development for the treatment of patients with metastatic melanoma and other solid tumors.
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, External Manufacturing with a strong background in GMP manufacturing operations and manufacturing science and technology for this brand-new role. In this role, you will work collaboratively with internal and external (CDMO/CMO) stakeholders to oversee technology transfer and manufacturing of our engineered cell therapies. As part of our Technical Development, Manufacturing, and Quality department, you will 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 cytoTIL15 engineered to make TILs more effective for more patients. This position is ideally based in our Bedford, MA location though we would consider candidates in the Philadelphia area.
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.
- Establish external manufacturing capabilities for Obsidian and provide leadership to internal and external teams focusing on GMP-compliance and technical expertise by identifying and assessing external manufacturing partners; Manage ongoing relationships with selected vendors and partners.
- Advise Obsidian leadership on future manufacturing strategy as our products move from early phase clinical trials toward commercial manufacturing.
- Apply your expertise in GMP manufacturing to provide manufacturing oversight of CDMOs for tech transfer and manufacturing activities.
- Build and maintain strategic relationships within the CDMO organization as well as key internal stakeholders.
- Author and review technical and scientific documents including but not limited to manufacturing protocols, reports and SOPs.
- Collaborate with cross-functional teams, including the CDMO joint project team, Obsidian Process and Analytical Development, Quality Assurance, Quality Control and External Manufacturing.
- Ensure success of tech transfer and manufacturing activities according to agreed upon timelines and business objectives.
- Align with CDMO on the appropriate formats and frequency of process and analytical data packages (raw data, graphed data, and other data summaries and presentations) and ensure delivery of such packages to enable Obsidian monitoring and analysis of data.
- Act as a Person-in-Plant (PIP) at Obsidian’s CDMO facilities by maintaining on-site presence as needed for extended periods (including some off-hours days to resolve urgent issues) as required, leading up to and during batch manufacturing.
- Partner with CDMO and internal stakeholders to understand planned changes and manage the end-to-end implementation process including but not limited to change controls and impact assessments.
- Perform detailed review of draft and completed batch records.
- Facilitate with cross-functional team to resolve manufacturing issues along with daily review of manufacturing investigations, change controls, complaints, and CAPAs.
- Work closely with CDMO and internal Quality, Supply Planning and Technical teams to prioritize and track documentation (including but not limited to change controls, investigations, and deviations) to meet Obsidian requirements.
- Manage shipments of critical materials to and from external partners as required.
- Recruit talent as needed and mentor/train team members on our manufacturing process focusing on GMP-compliance.
- Master’s degree in Life Sciences or related discipline, or equivalent experience.
- 8+ years of experience working in a bio-pharmaceutical manufacturing or MSAT role in the Cell Therapy space.
- A track record with cell culture techniques including but not limited to activation, transduction, and expansion of T cells.
- Subject Matter Expertise in Tech Transfer of a process to GMP manufacturing.
- Strong quality and compliance background in a clinical GMP operational environment.
- Strong technical writing skills.
- Strategic thinking – you see the big picture, plan ahead, and excel at problem-solving, decision-making, developing and implementing realistic action plans to achieve specific goals
- A leadership style oriented to high standards and support to succeed and grow. You engage input of team members in problem solving and decision making and encourage open and honest dialogue.
- A highly collaborative working style – you build healthy, productive and high trust relationships within your function and with direct stakeholders, invite and share ideas and feedback, productively challenge own and others’ assumptions to generate new ideas and facilitate better outcomes
- Self-motivation and a proven ability to work with general direction 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.
- Confidence and good judgement to elevate relevant issues to project lead and line management, and effectively influence actions and decisions.
- A desire and ability to work in a dynamic and entrepreneurial environment. Excellent oral and written communication skills.
- Ability to travel up to 33% of time.
- Prior experience working at or overseeing work completed at a CDMO/CMO.
- Experience with PPQ (process validation).
- Experience with T cells, specifically with TILs.
- Experience with gene therapy, including retroviral or lentiviral vectors.
- Familiarity with FDA and EMA guidance documents relevant to cell and gene therapy.
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.