Kincellis Advanced Therapies is a U.S.-based contract development and manufacturing organization supporting advanced-therapy developers from early-stage CMC, process and analytical development through clinical supply, pivotal-stage programs and commercial supply. With facilities in Gainesville, Florida; Research Triangle Park, North Carolina; and The Woodlands, Texas, Kincellis combines broad technical expertise with flexible, scalable GMP infrastructure across autologous and allogeneic therapies, including but not limited to CAR-T, Tregs, CAR-NK, MSCs, dendritic cell vaccines, exosomes, iPSCs & synthetic mRNA.
For more information, visit our website at www.kincellis.com.
Kincell is seeking a Process Engineer II who will lead complex technical work across multiple cell therapy unit operations or an integrated process segment. The role leads investigations, process characterization, technology transfer execution, validation activities, and cross-functional improvement initiatives while serving as a trusted technical resource to Manufacturing, Quality, and clients.
Role mission: Lead technical improvements across multiple interconnected unit operations and drive process robustness, transfer, and validation execution.
Essential Duties and ResponsibilitiesReasonable 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.
- Provide technical ownership for multiple interconnected unit operations or a complete upstream or downstream process segment.
- Lead complex deviation investigations and root cause analyses using structured tools such as 5-Why, fishbone, fault tree, and risk assessment.
- Plan and lead process characterization, engineering, comparability, and optimization studies using sound experimental design.
- Lead technology transfer execution, including gap assessment, facility fit, equipment fit, process risk assessment, readiness planning, and transfer documentation.
- Develop or lead process validation protocols, reports, acceptance criteria, and supporting risk assessments.
- Apply statistical methods such as DOE, SPC, capability analysis, and multivariate trending to improve process understanding and control.
- Lead cross-functional process improvement initiatives focused on yield, robustness, cycle time, contamination control, and right-first-time performance.
- Assess new equipment, single-use systems, raw materials, and manufacturing technologies and recommend implementation strategies.
- Author and approve technical content in SOPs, MBRs, protocols, reports, Change Controls, and regulatory support documents.
- Represent MSAT in regular client technical meetings and communicate risks, data, decisions, and recovery plans clearly.
- Mentor Associate Process Engineers and Process Engineers I through technical coaching and review of deliverables.
- Support audits, inspections, and program governance as a subject-matter expert for assigned processes.
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
Required:- Bachelor's degree in Engineering, Biology, Biotechnology, Life Sciences, or a related discipline with 4+ years of relevant experience; advanced degree may substitute for a portion of experience.
- Demonstrated experience leading investigations, engineering studies, technology transfer, validation, or process improvement in a GMP environment.
- Strong understanding of cell therapy manufacturing, aseptic processing, contamination control, and process risk management.
- Ability to manage multiple priorities and lead cross-functional technical projects with limited supervision.
- Strong technical writing, data analysis, presentation, and client communication skills.
- Experience with CAR-T, CAR-NK, CAR-M, TIL, gene-edited cell therapy, or related immune cell platforms.
- Advanced proficiency in statistical software and experimental design.
- Experience with client-facing CDMO work, regulatory submissions, comparability, or process performance qualification.
- Ability to work in GMP cleanroom environments (ISO 5-8) while wearing required PPE and gowning for extended periods.
- Ability to stand, walk, bend, reach, and perform repetitive hand movements during manufacturing support activities.
- Ability to lift, push, pull, and transport materials or equipment up to 25 pounds routinely and up to 40 pounds occasionally with assistance, if required.
- Ability to visually inspect equipment, labels, batch records, and technical documentation with attention to detail.
- Ability to support flexible scheduling, including occasional weekends, holidays, extended operations, or shift-based manufacturing support as required.
- Little to none; occasional travel may be required for client support, vendor activities, or technology transfer from client or between company sites.
- This position is 100% on-site in Gainesville, Florida and may require frequent non-standard working hours, including scheduled early mornings, late evenings, and/or weekends.
#LI-Onsite
Kincellis Advanced Therapies 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. Kincellis Advanced Therapies 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: Kincellis Advanced Therapies 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.
Skills Required
- Bachelor’s degree in Engineering, Biology, Biotechnology, Life Sciences, or a related discipline, with 4+ years of relevant experience; an advanced degree may substitute for part of the experience.
- Experience leading investigations, engineering studies, technology transfer, validation, or process improvement in a GMP environment.
- Strong understanding of cell therapy manufacturing, aseptic processing, contamination control, and process risk management.
- Ability to manage multiple priorities and lead cross-functional technical projects with limited supervision.
- Strong technical writing, data analysis, presentation, and client communication skills.
- Experience with CAR-T, CAR-NK, CAR-M, TIL, gene-edited cell therapy, or related immune cell platforms.
- Advanced proficiency in statistical software and experimental design.
- Experience with client-facing CDMO work, regulatory submissions, comparability, or process performance qualification.
- Ability to work in GMP cleanroom environments while wearing required PPE and gowning for extended periods.
- Ability to support flexible scheduling, including occasional weekends, holidays, extended operations, or shift-based manufacturing support.
What We Do
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
