Manager, Quality Control

Kincell is a technology-forward contract development and manufacturing organization (CDMO) that streamlines analytical development, process development, CMC consulting and early-stage GMP cell therapy manufacturing.

Our focus is on developing and manufacturing immune cell therapies, including autologous and allogeneic CAR-T, CAR-NK, and CAR-M programs.

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

Kincell is seeking a highly motivated Manager, Quality Control who will be a key contributor to a dynamic and collaborative Quality Control team.

The Manager – Quality Control is responsible for managing the activities of Quality Control personnel. The Quality Control manager must balance coaching technical staff, prioritization and staffing for routine production support activities, implementation of technical projects, and process optimizations. The position requires knowledge of cGMPs, industry standards for validation, and technical expertise on multiple analytical platforms including flow cytometry. The position requires working cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical and quality objectives.

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 of documents, including test records, investigations, change controls, validations, personnel qualification strategies, control strategies, technical studies, etc.
• Performance management and development of staff.
• Manages execution of daily activities to ensure QC deliverables are met.
• Plan and coordinate analytical method transfer, verification, qualification, and validation activities in a cGMP environment while adhering to industry standards and ICH guidelines.
• Provide technical expertise and demonstrate proficiency on the following analytical platforms: flow cytometry (BD Lyric), ELISA based assays (BMG Clariostar), qPCR (QuantStudio5), dPCR (Absolute Q), cell counting and viability (NC-200/202) and cell-based functional assays while adhering to industry standards.
• Act as QC flow cytometry subject matter expert (SME) and lead on analytical method transfer, verification, qualification, and validation activities for flow cytometric analytical methods.
• Partner within Quality Control and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
• Ensure adequate technical representation and engagement within site and network governance meetings to influence technical agendas.
• 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 another related field.
• 6+ of experience in Quality Control in a pharmaceutical manufacturing environment.
• An equivalent combination of education and experience may be considered.
• 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
• 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

Physical Demands

• Adjusting or moving objects weighing up to 30lbs
• Push/Pull up to 30lbs
• Vision Acuity Testing
• Climb Stairs (5 or more)
• Use of a face mask

Travel Requirements

• <10%

 Location

• This position is 100% on-site in Durham, North Carolina.

#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.