Scientist, Cell Therapy Process Development

AstraZeneca • Gaithersburg, MD

1d • Onsite

About The Position

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, and characterize culture processes. The position will require to perform gene editing activities and human primary cells manipulation. As a Scientist, you will independently design, implement, analyze, and document early and late-stage process development studies. You will collaborate within the team to interpret study results and contribute to technical discussions for subsequent study design and decision making. You will also contribute to tech transfer activities 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. Additionally, you will author and contribute to development reports, scientific publications, patents, and regulatory filings in different countries and regions.

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 cell editing technologies: CRISPR/Cas9, gene editing, etc.
• Experience with viral transduction techniques desirable.
• Scientific 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 early and late-stage process development studies.
• Collaborate within the team to interpret study results and contribute to technical discussions for subsequent study design and decision making.
• Contribute to tech transfer activities 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.
• Author and contribute to development reports, scientific publications, patents, and regulatory filings in different countries and regions.

Benefits

• Short-term incentive bonus opportunity
• Equity-based long-term incentive program (salaried roles)
• Retirement contribution (hourly roles)
• Commission payment eligibility (sales roles)
• 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: Entry Level
• Number of Employees: 5,001-10,000 employees