Process Engineer II, MSAT

Kincell Bio, LLC; Gainesville (FL); On-site; USD 95,000 - 125,000; Full time

Job summary

Kincell Bioengineers cells into therapies in Gainesville, FL, seeking a Process Engineer II to lead complex unit operations and drive process robustness. This role supports manufacturing, quality, and clients within a GMP CDMO setting, with emphasis on investigations, validation, and tech transfer.

The position requires a BS in a related field and 4+ years of experience, strong technical writing, data analysis, and ability to collaborate across cross-functional teams.

Qualifications

• Bachelor's degree and 4+ years in GMP-related cell therapy manufacturing or equivalent.
• Experience leading investigations, engineering studies, tech transfer, validation, or process improvement.
• Strong writing, data analysis, presentation, and client communication skills.

Responsibilities

• Provide technical ownership for multiple interconnected unit operations or a complete upstream or downstream process segment.
• Lead deviation investigations and root cause analyses using structured tools (5-Why, fishbone, fault tree).
• Plan and lead process characterization, engineering, comparability, and optimization studies with sound experimental design.
• Lead technology transfer, including gap assessment, facility and equipment fit, risk assessment and transfer documentation.
• Develop or lead process validation protocols, reports, acceptance criteria, and risk assessments.
• Apply DOE, SPC and multivariate analysis to improve process understanding and control.
• Mentor junior engineers and support audits, inspections, and governance as SME.

Skills

GMP experience

Cell therapy

Process optimization

DOE

Technical writing

Education

Bachelor's degree in Engineering/Biology/Biotechnology/Life Sciences

Tools

Statistical software

Process characterization tools

Job description

Kincell Bioengineers 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 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 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.

• 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.

Qualifications

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.

Preferred:

• 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.

Physical Requirements / Work Environment:

• 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.

Travel Requirements

• Little to none; occasional travel may be required for client support, vendor activities, or technology transfer from client or between company sites.

Location

• 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

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.