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Senior Manager/Associate Director, CMC Operations (Cell Therapy)
Obsidian Therapeutics is expanding the reach of TIL therapy. We are pioneering engineered tumor infiltrating lymphocyte (TIL) therapies to deliver transformative outcomes for patients suffering from solid tumor malignancies. Obsidian’s programs apply our cytoDRiVE® platform technology to express regulated therapeutic proteins to enhance anti-tumor activity. Obsidians’ lead program is currently in clinical 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 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 new facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.
We’re looking for a highly motivated CMC Operations professional to join our growing and collaborative team focused on translating innovative science into medical breakthroughs for patients. Reporting to the Director of CMC Operations and Strategy, the Senior Manager/Associate Director, CMC Operations will oversee CDMO activities for partnered CMC projects involving cell therapy product candidates and required starting materials (viral vector, feeders) for all phases of clinical development and commercialization.
The Senior Manager/Associate Director, CMC Operations will also work closely with Technical Development, Manufacturing, and Quality (TDMQ) leadership to drive operational execution of strategic projects; and establish a project management practice for CMC projects including the preparation and maintenance of project plans and budgets. The ideal candidate will bring a passion for project and operations management, experience with CDMO management, and a partnership style to collaborate and advance drug development in a fast-paced clinical stage biotech environment.
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.
- Work with the Director of CMC Operations and Strategy and TDMQ team members to develop and maintain an integrated project plan for CMC activities with timelines, and project dashboards to monitor and communicate progress, risks, and risk mitigation plans.
- Lead project teams within TDMQ to drive successful execution of both internal and external CMC partnerships in support of company strategy and goals.
- Actively monitor deliverables and activities of partners for designated CMC program(s) to ensure successful and timely execution; identify, communicate, and mitigate risks.
- Serve as project manager and primary CMC point-of-contact within Obsidian for assigned program(s).
- Plan and facilitate partner project meetings (agenda setting, meeting management, recording of minutes) in collaboration with counterpart at CDMO.
- Manage the relationship with designated CDMOs.
- Coordinate the drafting, negotiation, and approval of vendor and partner agreements and SOWs. Review and approve invoices, tracking against budget.
- Support TDMQ long-term planning and facilitate decision making related to investments in technology, manufacturing cost analysis, and facility / capacity planning.
- Bachelor’s degree in a scientific or engineering discipline; advanced degree in a scientific or engineering discipline desirable.
- 10+ years professional experience, with 3+ years' experience as a project manager leading functional or cross-functional teams within a CMC function at a drug development company.
- A solid scientific foundation and strong understanding of CMC development for cell therapy, gene therapy, or biologics products including regulatory requirements.
- Exceptional project management skills, managing complex and consequential projects to successful outcomes.
- A strong track record of building productive partnerships based on exceptional communication and collaboration toward shared goals.
- An ability to influence effectively throughout all levels of the Company and external partners.
- Highly collaborative working style – you build trusting relationships, invite and share ideas and feedback, productively challenge your own and others’ assumptions to generate new ideas and facilitate better outcomes.
- Self-motivation and a proven ability to work with general direction to meet objectives, timelines, and manage multiple responsibilities in parallel.
- Flexibility – you readily adapt to changing priorities and incorporate lessons learned in order to fulfill our mission.
- Confidence and good judgement to elevate issues to relevant partners, colleagues, and leadership.
- Strong attention to detail.
- Excellent oral and written communication skills.
- Proficiency with MS Excel, PowerPoint, and MS Project
- Prior experience in development of gene therapy and/or cell therapy product for immuno-oncology or other applications.
- Prior experience managing work at a CDMO.
- CMC experience taking a program from Pre-Clinical to Commercial.
- PMP Certification
Job level will be based on overall experience and capabilities.
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.