Process Engineer, Cell Therapy Process Development

We are looking for an Engineer to join our Autologous CAR-T Cell Therapy Process Development team. In this role, you'll be instrumental in supporting the development of a clinical manufacturing process of autologous CAR-T products. 

Summary of the group: 

The Autologous CAR‑T Process Development team within Cell Therapy Development & Operations (CTDO) is responsible for optimizing the cell‑engineering activities required to generate CAR‑T drug product and for end‑to‑end process development of autologous CAR‑T cell therapies. This includes early‑phase process optimization and next‑generation process development. The team partners cross‑functionally drive product optimization, troubleshoot and investigate manufacturing issues, and involve in technology transfer to clinical and commercial manufacturing sites. The group also supports resolution of manufacturing deviations and contributes to regulatory submissions, including data generation as well as drafting and reviewing submission documents. 

Main Duties & Responsibilities: 

This position within the Process Development team will involve substantial amount of hands-on cell culture work, essentially, human CAR-T cell generation and in vitro expansion, scale up, scale down and characterize culture processes.  

As a Process Engineer, you will  

• Independently design, implement, analyze, and document process development studies. 

• Collaborate within the team to interpret study results and contribute to technical discussions cross functionally for subsequent study design and decision making. 

• Contribute to manufacturing support efforts, including batch record and SOP development, real-time troubleshooting, investigation, and impact assessment of deviations, change control management, process monitoring and data analysis, and risk assessments. 

• Authors and contributes to development reports, scientific publications, patents, and regulatory filings in different countries and regions. 

• Works effectively and collegially as a team member within a highly matrixed organizational structure. 

Required Skills: 

• Experience with human primary cell culture (CAR-T cell culture experience highly preferred) and cell expansion. 

• Familiar with process development for cell therapies, including scale-up and cell characterization (flow cytometry, PCR, etc.). 

• Experience engineering CAR-T cells. Hands-on experience with genome editing tools and DNA/RNA transfection approaches. 

• Familiar with the fundamentals of DOE.  

• Strong background in experimental design and data analysis skills are essential. 

• Ability to think critically, analytically and have demonstrated troubleshooting and problem-solving skills based on deductive reasoning. 

• Excellent teamwork and communication skills, including proven technical writing skills are required. Position may require weekend work. 

Desired Skills: 

• Knowledge about immunology and GMP manufacturing is highly desirable.  

• Experience with viral transduction techniques is desirable. 

• Cell Engineering rigor in assessing own data and that of others. Utilizes forward-looking perspective to contribute to “go/no go” decisions. 

Education/Experience:  

• BS degree in Biochemical Engineering, Biomedical Engineering, Biotechnology, or related field with 2-5 years or MS degree with a minimum of 2 years of relevant proven experience. 

The annual base pay for this position ranges from $79,336.80 - $119,005.20. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.