Associate Director, QC Operations – Cell Therapy

🕒 5 days ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $175k - $214.5k / year

⏰ Full Time

🟠 Senior

😶‍🌫️ Therapist

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Obsidian Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 Series C on 2024-04

Biotechnology • Pharmaceuticals

Obsidian Therapeutics is a leading biotechnology company pioneering in the field of precision cell and gene therapy. Utilizing its proprietary cytoDRiVE® platform, the company engineers precision medicines by harnessing the power of regulated therapeutic proteins. Obsidian's innovative programs, including the OBX-115, target advanced melanoma and have been recognized by the FDA with both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations. Their pipeline of investigational therapies is designed to offer new hope for patients with unmet medical needs.

📋 Description

• 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.

🎯 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.

🏖️ Benefits

• Comprehensive medical, dental, and vision coverage • Company contributions to health savings and retirement accounts • Ample paid time off • Access to wellness programs • Rich career growth opportunities • Annual incentive bonus as a percentage of actual base salary • Long-term incentives in the form of employee stock options