Quality Control, Associate Director (External)
Bedford, MA
About Us
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. We are investigating OBX-115 and enrolling patients in an ongoing multicenter clinical trial in advanced melanoma and non-small cell lung cancer ( Agni-01 ).
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 facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.
On April 3, 2024, we announced closure of a significantly oversubscribed $160.5 million Series C financing with a top-tier syndicate of life science investors led by new investor, Wellington Management. Proceeds from the financing will advance Obsidian's lead program in its ongoing trials. We're focused on enrolling patients and reaching key clinical and regulatory milestones, as well as manufacturing scale-up ahead of pivotal trial readiness.
Our Opportunity
We're expanding our Quality team to support manufacturing with a critical CDMO partner for our clinical trials in metastatic melanoma and non-small cell lung cancer. In this role, you'll work closely with a dedicated team to initiate and oversee the manufacturing of our engineered autologous cell therapies. The ideal candidate will have experience directing and overseeing QC of drug product manufacturing completed at a CDMO, preferably in cell and/or gene therapy. As part of our Technical Operations team, you'll be a vital part of a highly collaborative team working to deliver OBX-115 to patients and achieve Obsidian's vision of translating innovative science into medical breakthroughs.
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 will join a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.
You Will
- Direct and oversee method validation and transfer activities, including tech transfer to an external CDMO, to ensure GMP compliance.
- Lead QC investigation of quality events including laboratory investigations, OOS/OOT and deviations, and support manufacturing investigations as needed.
- Support development of specifications for raw material, drug substance, intermediate and final product testing, and stability testing.
- Author and review test methods, protocols, reports and associated documents.
- Support data trending and quality metrics.
- Support regulatory submission activities.
- Collaborate closely with QA, Regulatory, Supply Chain, MSAT, AD, and PD groups and external key partners.
- Assist with continuous improvement of quality and compliance.
- Regularly perform QC Person In Plant activities at Obsidian's CDMO facilities, and other duties as needed.
You Bring
Core Qualifications
- Bachelor's degree in biology, chemistry, life sciences or a related field, and 12+ years of analytical experience in biologics or CGT industry with at least 6 years in GMP QC (or M.S. and 8+ years of experience with 4 GMP QC experience).
- Expertise with analytical method transfer and phase appropriate validation/qualification.
- Familiarity with relevant FDA/EMA and ICH regulatory guidelines relevant to gene and cell therapy analytical development and method validation.
- Experience enabling and overseeing contract test laboratories for cell and/or gene therapy products and managing quality events and investigations.
- Experience with late phase to commercial programs (cell therapy, gene therapy or biologics).
- Experience with QC analytical methods optimization and troubleshooting for cell and gene therapy products including potency assay, immunoassays/flow cytometry, PCR, etc.
- A clear sense of ownership and accountability to meet commitment and high standards promoting the same with CDMO partners.
- A team mindset and highly collaborative working style - build trusting relationships, share ideas and feedback, productively challenge own and others' assumptions to generate new ideas and facilitate better outcomes. Ability to communicate effectively with scientific/technical colleagues in a dynamic, cross-functional environment.
- Proven ability to manage multiple matrixed projects and tasks to completion in a fast-paced environment, anticipating risks and obstacles and adjusting to effective contingency plans.
- Self-motivation and a demonstrated ability to work with general direction to meet objectives and timelines.
- Flexibility - ability to adapt to changes and priorities to fulfill our mission, including after-hours or weekend support for batch release when required to deliver product to a patient.
- Systems thinking - You approach problem solving and process design with consideration of the overall system as well as its individual parts, considering interrelationships and patterns.
- A track record of context-based sound judgement, including when to elevate risks and issues to leadership.
- An ability to be on-site at CDMO up to 30-40% of time (for day trips, the ideal location is mid-Atlantic; for other locations travel of this amount will be required).
Bonus Qualifications
- Background in microbiological techniques and cleanroom environmental monitoring.
Please no agency solicitation at this time. Thank you.
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.