Process Engineer, Cell Therapy Process Development

AstraZeneca • Gaithersburg, MD

3d • Onsite

About The Position

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. 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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level