Process Engineer I, Manufacturing Science and Technology

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 Process Engineer I, MSAT, who will be a key contributor to a dynamic and collaborative Manufacturing team.

The Process Engineer I will work closely with Process Development, Manufacturing, Quality Control, and Regulatory Affairs to define and implement the manufacturing strategy. The individual will support technology transfers and technical oversight of manufacturing campaigns. They will also be involved in the definition and execution of process validation activities needed in the preparation of applications for licensure. The Process Engineer I will also provide input to the Development Team, contributing to continuous process optimization and characterization throughout the entire product development lifecycle.

The ideal candidate will have experience in the process development and manufacture of biologics and cell therapies. They will have a proven track record of successful technology transfers and GMP manufacturing of clinical trial material, in addition to close interaction with Quality Assurance and Quality Control. The ideal candidate will have strong interpersonal skills and a high level of independence to carry out their responsibilities with minimal supervision.

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.

• Support manufacturing of cell therapy drug products (e.g., CAR-T)
• Support Process Technology Transfer activities (incl. personnel training) and provide technical oversight of manufacturing unit(s) during manufacturing campaigns
• Responsible for updating campaign process data and sharing with clients
• Work collaboratively Manufacturing, Quality Assurance, and Quality Control to ensure timely manufacturing and release of GMP-compliant drug product
• Support technical troubleshooting, investigations, root cause analysis, CAPAs, impact assessment, and change controls
• Author and/or review manufacturing documentation (e.g. Protocols, Process Description, Batch Records, SOPs, Change Controls, and manufacturing campaign summary reports)
• Contribute to the writing and review of IND/IMPD filings
• Contribute to the execution of process validation
• Provide engineering input and support to Process Development teams
• Conduct risk assessment (FMEA, CQA, and CPP identification) and COG analysis with the intent to identify key areas of process optimization and revise and optimize process control strategy
• Contribute to the writing of the Technical Operation SOPs (e.g. SOPs, protocols, reports) to meet global regulatory expectations, as required
• Perform other related duties as assigned

Qualifications

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

Required:

• BS in Chemical Engineering, Biological Engineering or relevant biological sciences discipline with 2+ years of biopharma process development or manufacturing experience of complex biologics, or equivalent training and experience
• Experience with internal/external technology transfers
• Experience in cell therapy
• Experience in process validation, investigations (technical report writing) and CAPA implementation
• Excellent working knowledge of GMP and GLP requirements
• Strong understanding of Quality Systems and demonstrated proficiency in the application of Quality Assurance principles, concepts, industry practices, and standards required
• Excellent communication skills, both verbal and written and the ability to interface effectively with all levels of the organization, strong communication skills with outside contract organizations is required

Preferred:

• Working knowledge of process and raw material characterization
• Strong conceptual, strategic, analytical, problem-solving, and organizational skills
• Autonomous, take-charge, proven team player with a strong results orientation, positive “can do” attitude, and a sense of urgency to get things done
• High emotional intelligence, sound temperament, and professional attitude
• Working knowledge of engineering statistics; ASQ certifications are a plus

Travel Requirements

• >10%

Location

• This position is 100% on-site, located in Durham, NC. (Research Triangle Park) l. This position may require some non-standard working hours, including early mornings or later evenings on weekdays and weekends

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.