Associate Director, QC Operations – Cell Therapy

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Provide strategic and operational guidance for Drug Product initiatives supported by external manufacturing and testing partners.

• Develop systems and processes, and organize resources to establish and achieve product release timelines.

• Oversee QC operations for CDMOs and contract test laboratories (CTLs).

• Direct and manage method validation and transfer activities, including technology transfer to an external CDMO, ensuring GMP compliance.

• Assist in preparing for PPQ readiness and BLA activities.

• Lead QC investigations into quality events, including laboratory investigations, OOS/OOT occurrences, and deviations, while supporting manufacturing investigations at CDMOs and CTLs.

• Aid in the development of specifications for raw materials, drug substances, intermediates, and final product testing, including stability assessments.

• Write and review test methods, protocols, reports, and related documentation.

• Support data trending and quality metrics analyses.

• Assist with regulatory submission processes.

• Collaborate closely with QA, Regulatory, Supply Chain, MSAT, AD, and PD teams, as well as with external key partners.

• Monitor and assess external laboratory performance using KPIs to drive improvements in efficiency and right-first-time execution.

• Contribute to the continuous enhancement of quality and compliance.

• Regularly execute QC Person In Plant activities at Obsidian’s CDMO facilities and perform other duties as required.

⛳️ Requirements

• Bachelor’s degree in biology, chemistry, life sciences, or a related field, with 10+ years of analytical experience in biologics or CGT in an industry context (or an M.S. with 8+ years of experience).

• Minimum of 6 years of experience in a GMP environment.

• Proficiency in analytical method transfer and phase-appropriate validation/qualification.

• Familiarity with relevant FDA/EMA and ICH guidelines related to gene and cell therapy, analytical development, and method validation.

• Experience in enabling and overseeing contract test laboratories for cell and/or gene therapy products, as well as managing quality events and investigations.

• Background in late-phase to commercial programs (cell therapy, gene therapy, or biologics).

• Expertise in QC analytical method optimization and troubleshooting for cell and gene therapy products, including potency assays, immunoassays/flow cytometry, PCR, etc.

• Strong sense of ownership and accountability to meet commitments and uphold high standards with CDMO partners.

• Effective communication skills with scientific and technical colleagues in a fast-paced, cross-functional environment.

• Excellent organizational abilities, proven track record of managing multiple matrixed projects and tasks to completion while anticipating risks and adjusting contingency plans.

• Flexibility to adapt to changing priorities to fulfill the mission, including potential after-hours or weekend support for batch releases when necessary.

• Systems thinking approach to problem-solving and process design, considering both overall systems and individual components, along with their interrelationships and patterns.

• Proven ability to exercise context-based sound judgment, including recognizing when to escalate risks and issues to leadership.

• Willingness to be on-site at a CDMO for 30-40% of the time.

• Collaborative and accountable mindset, understanding that success requires interdisciplinary collaboration and teamwork; open to sharing feedback and ideas, and constructively challenging assumptions to achieve better results.

• Self-motivated with a demonstrated ability to work with general direction to achieve objectives and timelines while managing multiple responsibilities concurrently.

• Curious and humble, seeking and welcoming the input and expertise of others, with a commitment to continuous learning.

• Tenacious and resilient, able to handle challenges without becoming overwhelmed, and committed to delivering on promises.

🏝️ Benefits

• Comprehensive medical, dental, and vision insurance.

• Company contributions towards health savings and retirement plans.

• Generous paid time off.

• Access to wellness programs.

• Extensive career advancement opportunities.

• Annual incentive bonus based on actual base salary.

• Long-term incentives available through employee stock options.