Quality Control, Associate Director

This position will be remote based in the Mid-Atlantic region or Boston area with 30-40% of time spent at a Mid-Atlantic based CDMO.

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.

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).
• Familiarity with relevant FDA/EMA and ICH regulatory guidelines relevant to gene and cell therapy analytical development and method validation.
• Expertise with analytical method transfer and phase appropriate validation/qualification.
• 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).