Process Engineer II, MSAT

Kincell Bio, LLC•Gainesville, FL

11d•Onsite

About The Position

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. 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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.