Manager, Analytical Development

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 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 and highly motivated Analytical Development Manager with a strong background in flow cytometry and developing, establishing and qualifying cell-based assays to join our growing organization. The Analytical Development Manager will be able to solve complex problems by applying current best technical practices and be able to connect cross-functionally to leverage methodologies used in other fields as well as their own.  They will also 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 a requirement.

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.

• 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 pointed technical reports suitable for executive management.
• Communicates effectively within the department, across functions, and with clients.
• Demonstrates the ability to help direct reports learn to break down and solve complex multifactorial problems.
• Successfully anticipates client questions and is prepared with 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 effective planning, mentoring, directing, and coordination of Analytical Development activities.
• Prepares and performs personnel evaluations, competency development, and administer performance reviews.
• Performs other duties as assigned by the Head of the Department

Qualifications

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

• BS., M.S., PhD degree in a scientific field or related science discipline
• A minimum of 4 years of cell therapy or related experience in an analytical development lab.
• A minimum of 1 year of Supervisory/Management experience.
• An equivalent combination of education and experience may be considered.
• Must have experience working in an environment with cGMP and quality system constraints.
• Strong work ethic with the ability to meet rapidly evolving and dynamic business priorities.
• Possess the ability to adapt to rapid changes in business priorities proactively and foster teamwork among employees to maintain high-quality standards.
• Ability to drive functional, technical, and operational excellence.
• Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness
• Experience transferring, developing, and qualifying methods is required.
• Technical writing skills are necessary.
• A strong sense of responsibility, strong work ethic, self-motivated attitude, and teamwork orientation are an absolute must.
• Excellent verbal and written communication skills are required.
• Ability to multitask strategically and tactically.
• Strong organizational skills; able to prioritize and manage complex processes/projects.

Preferred:

• Either a M.S. degree with 6+ years of assay development and validation experience or; a PhD degree in Cellular Biology, Immunology or related field with a minimum of 4+ years of industry experience.
• Preference will be given to candidates with experience developing cell-based and flowcytometric method in support of cell therapy clinical programs.

Travel Requirements

• The Scientist III will be expected to travel to all applicable locations when needed. 

Location

• This position is 100% on-site in Gainesville, Florida.

#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.