Associate Director, QC Operations – Cell Therapy

Role Overview

• 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