Associate Director, Quality Control

 

Kincell Bio engineers cells into therapies. With manufacturing facilities located in Research Triangle Park, NC and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, apply expertise in analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch.  Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, TCR, TILs, Tregs and CAR-NK technologies. We offer challenging career opportunities, competitive benefits, and an environment that recognizes and rewards performance.

For more information, please visit our website at www.kincellbio.com.

 

Kincell is seeking a highly motivated Associate Director, Quality Assurance who will be a key contributor to a dynamic and collaborative Quality Assurance team.

The Associate Director – Quality Control Lab will provide strategic, technical, and operational leadership for analytical quality control supporting cell therapy manufacturing.  This role oversees development, validation, qualification, and routine execution of assays required for release, stability, in-process, and characterization testing of cell-based products. The Assoc. Director Quality Control must balance coaching a technical staff, prioritization and staffing for routine production support activities, implementation of technical projects, and process optimizations. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation. The position requires working cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical objectives, specific product business plan, and quality objectives. The successful candidate will lead a high-performing QC analytical team, ensure regulatory and cGMP compliance, partner cross-functionally to support tech transfers and method lifecycle management, and drive continuous improvement to enable robust and phase-appropriate QC operations.

Essential Duties and Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.

• 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.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

• 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

Management Responsibilities:

• Hire, recruit, coach, and train employees within the Quality Control group
• Continuously assess and ensure the appropriate Quality Control structure is in place to support growth. Identify gaps and ensure the proper hiring and development of employees with the support of Human Resources.
• Set expectations, provide feedback and coaching, and take necessary action to ensure appropriate performance and goal attainment.

 

Physical Demands

• Adjusting or moving objects weighing up to 25lbs

Travel Requirements

• Minimal travel (up to 5%) will be expected in this position.

Location

• This is a site-based position in Durham, NC, and it will require some non-standard working hours, including early morning or late evening.

 

#LI-Onsite.

Kincell Bio provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable, federal, state, and local laws. Kincell Bio complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

NOTE TO EMPLOYMENT AGENCIES: Kincell Bio values our relationships with our Recruitment Partners. We will only accept resumes from those partners who have been contracted by a member of our Human Resources team to collaborate with us. We are not responsible for any fees related to resumes that are unsolicited or are received without contract.