Our Opportunity...

We’re expanding our Quality team and looking for an Associate Director of QC Operations 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 from clinical to commercial, preferably in cell and/or gene therapy.

As a member of our Quality team you'll be a vital part of a highly collaborative team working to achieve the Obsidian’s vision by 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 remote role requiring as-needed travel to support job duties.

You Will...

Core responsibilities

• Provide strategic and operational leadership for Drug Product programs supported through external manufacturing and testing partners.
• Build systems/processes and organize resources to establish and achieve product release cycle times
• Provide QC oversight of CDMOs and contract test laboratories (CTLs)
• Direct and oversee method validation and transfer activities, including tech transfer to an external CDMO, to ensure GMP compliance.
• Assist with PPQ readiness and BLA preparatory activities
• Lead QC investigation of quality events including laboratory investigations, OOS/OOT and deviations, and support manufacturing investigations at CDMOs and CTLs
• 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.
• Monitor and evaluate external laboratory performance using KPIs, driving improvements in efficiency and right-first-time execution
• 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 10+ years of analytical experience in biologics or CGT in an industry setting (or M.S. and 8+ years of experience).
• At least 6 years of experience in a GMP setting.
• 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.
• Ability to communicate effectively with scientific/technical colleagues in a dynamic, cross-functional environment.
• Excellent organizational skills, with a 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.
• 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.
• Collaborative and accountable – recognizes success requires interdisciplinary thinking and teamwork; shares feedback and ideas, productively challenges own and others’ assumptions to facilitate better outcomes
• Self-motivated, with a proven ability to work with general direction to meet objectives and timelines, managing multiple responsibilities in parallel.
• Curious and humble – seeks and welcomes input/expertise of others, continuous learner
• Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments
• Operates with urgency, adept at building buy-in and driving alignment within and across teams, senior leadership, and external partners. ​
• Seeks the data, information, and support needed (internally and externally) to make efficient and informed decisions and meet objectives. ​
• Continuous learner – actively follows innovations in area of expertise, fosters innovative thinking, and adopts novel approaches that are fit for purpose; reflective and selfaware.​