Scientist III, Process 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.

 

The Scientist III will lead process development programs and be a process development expert.  Staying current with best practices and advancements is anticipated and should result in creative and inspiring suggestions for alternative methodologies and processes.  He/She will lead in solving 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 his/her own.  The Scientist III will demonstrate a sense of urgency while maintaining respect for best practices and an understanding of the importance and applicability of quality and controls in development activities.

Problem-solving, data analysis, and interpretation will be focused and data-driven and result in thorough documentation and pointed technical reports suitable for area management and clients.  The Scientist III will be well-versed in internal and external best practices, lead internal and external programs and operations, and be an SME in interactions with company colleagues.  It is expected that he/she will continuously improve operational effectiveness and participate in the recruitment of technical staff to maintain an effective level of technical ability for all business requirements.

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.

• Leads process development operations, runs, and programs
• Creates and presents data presentations suitable for cross functional and client meetings
• Successfully anticipates client questions and is prepared with appropriate responses, deliverables, and feedback to support the client
• Directs the development of cell therapy production processes and process improvements
• Oversees Process Transfer into Facility and to Destination Unit
• Leads internal process improvement initiatives
• Demonstrates the ability to consistently break down and solve complex multifactorial problems
• Other duties as assigned

Qualifications

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

• S. degree and 7+ years, a M.S. degree and 5+ years, or a Ph.D. degree in life sciences with 3+ years of Bioprocess or Bioscience industry experience.
• Experience with eukaryotic cell culture, aseptic technique, and experience with general laboratory equipment (e.g centrifuge, scales, pumps, welders/sealers) required
• Experience with chromatography, cGMP manufacture, and technology transfer is a plus.
• Experience with the development of CGT and other bioprocesses is highly desired.
• The ability to independently design experiments, analyze data, and interpret and present experimental results is required.
• Directs the development of cell therapy production processes and process improvements
• 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.

Physical Demands

• Adjusting or moving objects weighing up to 30lbs

Travel Requirements

• N/A

Location

• This is a site-based position located in Gainesville, FL, 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.