Associate Director, QC Operations - Cell Therapy

Obsidian Therapeutics•Bedford, MA

1d•$175,000 - $214,500•Remote

About The Position

Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our cytoDRiVE® 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 clinical development for the treatment of patients with metastatic melanoma and non-small cell lung cancer. 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 Technical Operations team is based in our purpose built facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options. 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.

Requirements

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 self aware.

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.