Kincell Bio · 1 day ago
Associate Director, Quality Control
Durham, NC
Full-time
Onsite
Lead/Staff, Director/Executive
8+ years expKincell Bio engineers cells into therapies and is seeking a highly motivated Associate Director, Quality Control to lead a dynamic Quality Assurance team. This role involves providing strategic, technical, and operational leadership for analytical quality control supporting cell therapy manufacturing, overseeing the development and execution of assays, and ensuring compliance with regulatory standards.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc
Provide scientific and managerial leadership for QC functions supporting clinical and commercial cell therapy programs
Build, mentor, and manage a team of scientists and analysts; establish strong technical capability in cell-based, molecular, analytical, microbiological, and immunological methods
Along with Analytical Development, develop long-term QC strategy including method lifecycle management, assay robustness, and future-state technologies
Partner within Quality Control and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives
Oversee daily operations of the QC Lab to ensure safe, efficient, and compliant execution of testing activities
Ensure availability, qualification, and maintenance of QC equipment, reference standards, critical reagents, and controlled documents
Own and approve investigations, deviations, CAPAs, OOS/OOT results, change controls, and method performance reviews. Ensure adequate oversight and technical excellence for investigations and complaints
Lead qualification, validation, transfer, and ongoing monitoring of analytical methods for cell therapy release and stability testing
Collaborate with Analytical Development, Process Development, MS&T, and external partners on method transfer, trending, and troubleshooting
Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal, external, and regulatory agency audits
Ensure QC operations comply with FDA, EMA, ICH, USP, and other applicable regulatory guidelines for cell and gene therapy products
Work closely with Manufacturing, QA, Supply Chain, and MS&T to support lot disposition, process changes, and lifecycle initiatives
Provide scientific expertise on analytical trends and product quality attributes; contribute to control strategy and risk assessments
Define strategic direction and provide oversight for the technical agenda to improve process control, yield, and/or productivity for all products within the site portfolio
Ensure adequate oversight for technical projects to improve process control, capacity, yield, quality
Ensure adequate technical representation and engagement within site and network governance meetings to influence technical agendas
Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites
Potential to engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization
Other duties as assigned
Qualification
Required
Bachelor's Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or other related field
8+ of experience in Quality Control in a pharmaceutical manufacturing environment. A minimum of 3 years of management in a Quality Control laboratory
Direct involvement in tech transfer, method lifecycle management, and phase-appropriate analytical strategy
Strong experience in QC analytical testing of cell therapy, gene therapy, or biologics; CAR-T experience preferred
Previous experience in contract development and manufacturing organizations preferred
Proven ability to navigate regulatory expectations for ATMPs, including assay validation and method lifecycle management
Responsible for maintaining a safe work environment
Ability to influence and lead diverse groups
Influences complex regulatory, business, or technical issues within the site and function
Experience in statistics
Technical leadership, administrative and organizational skills
Strong leadership and team-building skills; ability to develop talent and foster a culture of scientific excellence
Builds relationships with internal and external customers and partners
Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional
Demonstrated Project Management skills and ability to coordinate complex projects
Strong analytical and quantitative problem-solving skills
Ability to communicate and influence effectively across functional groups and stakeholders
Strategic thinking and ability to balance short-term needs with long-term business evolution
Enthusiasm for changes, team spirit and flexibility
Demonstrated ability to learn & apply technical/scientific knowledge
Preferred
Strong experience in QC analytical testing of cell therapy, gene therapy, or biologics; CAR-T experience preferred
Previous experience in contract development and manufacturing organizations preferred
Benefits
Competitive benefits
Company
Kincell Bio
Kincell Bio collaborates with cell therapy developers by using considerable scientific experience and industry understanding.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$58MKey Investors
Kineticos Ventures
2025-05-15Series Unknown· $22M
2023-07-26Series A· $36M
Leadership Team
Bruce Thompson
Chief Executive Officer
Recent News
2026-01-06
Precedence Research
2025-11-27
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