Aseptic Process Engineer Jobs in Reston, VA (NOW HIRING)

Associate Specialist (Cell Therapy Manufacturing)

Introduction to role

Are you ready to bring precision and initiative to the start-up of a new cell therapy manufacturing facility-seeing your work translate into clinical trials that could change patients' lives? Join a team producing next-generation cell therapy products at a pivotal moment as our first clinical batches move from process development into cGMP operation.

In this visible, hands-on role, you will collaborate daily with Process Development, Clinical Operations, Materials Management, and Quality to turn robust science into reliable manufacturing outcomes. You will help build the documentation, run sophisticated automated equipment in Grades A and B cleanrooms, and lead by example on the floor to keep every batch on track. Can you picture yourself owning a "right first time" mindset and guiding a shift handover that keeps a critical lot moving?

Accountabilities

• GMP Documentation Excellence: Author and execute manufacturing batch records, work instructions, and SOPs with a "right first time" mindset; maintain bills of materials; reconcile batches promptly; document all activities to meet cGMP requirements; assist with deviations, non-conformances, and OOS investigations. Your rigor reduces errors, speeds release, and strengthens audit readiness.
• Aseptic Equipment Operations: Monitor, clean, prepare, and operate automated cell processing, cell expansion, and filling equipment in Grades A and B cleanrooms. Your care and consistency protect product quality and patient safety.
• Training and Knowledge Transfer: Train personnel on aseptic processing, equipment operation, cGMPs, documentation, and technical theory. By elevating team capability, you increase throughput and reliability.
• Document Review and Continuous Improvement: Review batch records, SOPs, and logbooks for completeness, clarity, and accuracy; submit edits for revision as needed. Your attention to detail drives procedural clarity and repeatability.
• Tech Transfer and Process Development: Participate in tech transfer activities; support development of platform processes; contribute to study and experiment designs; modify or improve processes and systems when appropriate. Your input helps mature processes from concept to cGMP readiness.
• Floor Leadership and Problem Solving: Provide technical instruction; allocate administrative tasks; assign work to manufacturing staff; lead activities on the manufacturing floor; communicate product status at shift change; troubleshoot processing and equipment issues. Your leadership keeps operations aligned, responsive, and efficient.
• Safety and Compliance Stewardship: Ensure a safe work environment in accordance with AstraZeneca standards. Your vigilance fosters a strong safety culture.
• Flexibility: Weekend work may be required. Your adaptability ensures continuity of critical manufacturing runs.

Essential Skills/Experience

• Bachelor's degree in life sciences, engineering, or a related field with 0-3 years of general cGMP manufacturing experience or a Master's degree in life sciences, engineering, or a related field with 0-2 years of general cGMP manufacturing experience
• Basic knowledge in biologics manufacturing process, cell culture and/or vector products.
• Technical proficiency in aseptic technique and working with manufacturing equipment in open and closed systems.
• Working knowledge of automated manufacturing equipment and/or process analytical technologies.
• Proficiency in Microsoft Word, Excel and data analysis.

Desirable Skills/Experience

• Previous manufacturing or process development experience with cell therapy or vector products.
• Dynamic individual with the ability to communicate and engage others.
• Independent and self-starting. Ability to work with minimal supervision.
• Demonstrate flexibility and willingness to change ways of working/identify opportunities to improve processes within cGMP clinical manufacturing environment.

Why AstraZeneca

Here, your work sits close to the decision point and the patient impact. You will operate at the forefront of science with high visibility, shaping end deliverables across therapy areas and collaborating with unexpected teams in the same room to unleash bold thinking. We balance ambition with support-leaders empower you to improve, experiments are celebrated for what they teach, and resilient minds find inventive paths through a heavily regulated environment. You will expand your skills as you apply advanced technologies to complex problems, contribute to enterprise-recognized work, and bring courage and curiosity to challenges that truly matter. We value kindness alongside ambition, and we back people who speak up, share opinions, and turn critique into better solutions.

Step into this high-exposure manufacturing role and help deliver transformative cell therapies to patients-take the next step today and show us how your precision and initiative will raise our standards!

The annual base pay for this position ranges from $65,082 to $97,622. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.