Process Engineer, Cell Therapy Process Development

We are looking for anEngineerto join ourAutologous CAR-TCellTherapy Process Development team. In this role,you'llbe instrumental in supporting the development of a clinical manufacturing process ofautologousCAR-T products.

Summary of the group:

The Autologous CAR‑T Process Development team within Cell Therapy Development & Operations (CTDO)is responsible foroptimizingthe 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‑functionallydriveproduct optimization, troubleshoot and investigate manufacturing issues, andinvolve intechnology 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 withintheProcess Development teamwill involve substantialamountofhands-oncell culture work,essentially,humanCAR-T cell generation and in vitro expansion,scale up,scaledownand characterize culture processes. 

As a Process Engineer, you will 

• Independentlydesign, implement, analyze, and document process development studies.

• Collaborate within the team to interpret study results and contribute to technical discussions cross functionally forsubsequentstudy 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, processmonitoringand data analysis, and risk assessments.

• Authors andcontributesto 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)andcell expansion.

• Familiar withprocess development for cell therapies, includingscale-upand cell characterization(flow cytometry, PCR, etc.).

• ExperienceengineeringCAR-T cells.Hands-on experience with genome editing toolsandDNA/RNA transfectionapproaches.

• Familiar with the fundamentals of DOE.

• Strong background in experimental design and data analysis skillsareessential.

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

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

Desired Skills:

• Knowledge about immunology and GMP manufacturing is highly desirable. 

• Experience with viral transduction techniquesis desirable.

• Cell Engineeringrigor 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.