Manager, Analytical Development

Overview

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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) focused on streamlining CMC development, applying expertise in analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch. We support 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 rewards performance.

Kincell is seeking a highly motivated Analytical Development Manager who will be a key contributor to a dynamic and collaborative Analytical Development team. To continue our rapid growth, we are seeking a talented Analytical Development Manager with a strong background in flow cytometry and developing, establishing and qualifying cell-based assays to join our organization. The manager will solve complex problems by applying current best technical practices and connect cross-functionally to leverage methodologies used in other fields. They will demonstrate strong interpersonal skills and have experience managing scientific teams. A sense of urgency while maintaining respect for best practices and an understanding for the importance and applicability of quality and controls in development activities is required.

Responsibilities

• Acts as technical resource and subject matter expert (SME) in the development of molecular, cell-based, and flow cytometry-based methods.
• Independently plans, prioritizes, and coordinates analytical method development, qualification, validation, and tech transfer activities in a cGMP environment while adhering to industry standards and ICH guidelines with client timelines in mind.
• Responsible for maintaining the integrity of work areas including maintenance and calibration of equipment, general work center safety, and cleanliness in compliance with established Quality standards.
• Creates and delivers presentations and technical reports suitable for executive management.
• Communicates effectively within the department, across functions, and with clients.
• Mentors and develops direct reports by guiding problem-solving of complex multifactorial issues.
• Anticipates client questions and provides appropriate responses, deliverables, and feedback to support the client.
• Interacts with auditors / clients during visits and tours.
• Builds and oversees a team of AD Scientists through planning, mentoring, directing, and coordination of Analytical Development activities.
• Prepares and performs personnel evaluations, competency development, and performance reviews.
• Performs other duties as assigned by the Head of the Department.

Qualifications

Preferred

Travel Requirements

Location

Equal Employment Opportunity

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.

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