Quality Assurance, Senior Manager/Associate Director (External) at Obsidian Therapeutics

Quality Assurance, Senior Manager/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 QA 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…

• Provide QA direction and oversight for process and method transfer/validation, testing and release activities at external CDMO to ensure GMP compliance.
• Review and approve method transfer and tech transfer protocols and reports.
• Review master batch records, executed batch records, test methods, QC test documentation, COAs, COCs, and associated documentation to support timely release of clinical trial materials.
• Support development or review of SOPs and specifications.
• Direct investigation of quality events including laboratory investigations, OOS/OOT and deviations, complaints etc.
• Support development of quality metrics and risk assessment as needed.
• Support regulatory submission activities.
• Collaborate closely with QA, QC, Manufacturing, MSAT, AD and PD groups, and other key partners.
• Assist with continuous improvement of quality and compliance.
• Regularly perform QA Person In Plant activities at Obsidian’s CDMO facilities, and other duties as needed.
• Participate in inspection readiness activities and provide support during regulatory site inspections.
• Participate in Obsidian IND preparedness.
• Participate in Vendor/Supplier Qualification activities (i.e. Audits, site visits).
• Participate in process improvement initiatives (as necessary), performing gap analysis and risk communication.

You Bring…

Core Qualifications

• Bachelor’s degree in biology, chemistry, life sciences or a related field, and 8+ years of progressive QA experience in biotech (or MS and 6+ years).
• Strong CMC background and GMP quality background for ATMPs.
• Experience providing QA support and oversight of GMP manufacturing operations for cell and/or gene therapy products, including batch release.
• Experience with CDMO manufacturing and testing with proficient knowledge of cGMP's and associated CMC regulatory considerations.
• Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA.
• Thorough knowledge of FDA and ICH regulatory guidelines and cleanroom environmental monitoring requirements.
• A clear sense of ownership and accountability to meet commitments 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.
• Systems thinking – You approach problem solving and process design from 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.
• 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.
• 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

• Experience with regulatory agency inspections.

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.