Specialist (Cell Therapy Manufacturing)
Rockville, MD - USA
Job Summary
Introduction to role
Are you ready to bring precision and initiative to the start-up of a new cell therapy manufacturing facilityseeing 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
Bachelors or Masters degree in life sciences engineering or a related field with 3 years of experience in cGMP Manufacturing including 1 in cell therapy at a minimum.
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 supportleaders 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 patientstake 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 $81993 to $122989. Our positions offer eligibility for various incentivesan 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
07-Aug-2026Closing Date
14-Aug-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.
Required Experience:
IC
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more