Specialist (Cell Therapy Manufacturing)

AstraZeneca • Rockville, MD

3d • $81,993 - $122,989 • Onsite

About The Position

This role is a hands-on position in a new cell therapy manufacturing facility, focusing on the transition from process development to cGMP operation. The Specialist will collaborate with various departments to ensure reliable manufacturing outcomes, build documentation, operate automated equipment in cleanrooms, and maintain a "right first time" mindset. The position offers high visibility and the opportunity to contribute to clinical trials that could impact patients' lives.

Requirements

• Bachelor's or Master's degree in life sciences, engineering, or a related field.
• 3+ years of experience in cGMP Manufacturing.
• 1+ year of experience in cell therapy manufacturing.
• 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.

Nice To Haves

• 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 with the 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.

Responsibilities

• Author and execute manufacturing batch records, work instructions, and SOPs with a "right first time" mindset.
• Maintain bills of materials and reconcile batches promptly.
• Document all activities to meet cGMP requirements.
• Assist with deviations, non-conformances, and OOS investigations.
• Monitor, clean, prepare, and operate automated cell processing, cell expansion, and filling equipment in Grades A and B cleanrooms.
• Train personnel on aseptic processing, equipment operation, cGMPs, documentation, and technical theory.
• Review batch records, SOPs, and logbooks for completeness, clarity, and accuracy; submit edits for revision as needed.
• Participate in tech transfer activities.
• Support development of platform processes.
• Contribute to study and experiment designs.
• Modify or improve processes and systems when appropriate.
• Provide technical instruction and allocate administrative tasks.
• Assign work to manufacturing staff and lead activities on the manufacturing floor.
• Communicate product status at shift change.
• Troubleshoot processing and equipment issues.
• Ensure a safe work environment in accordance with AstraZeneca standards.
• Perform weekend work as required.

Benefits

• Qualified retirement programs
• Paid time off (vacation, holiday, and leaves)
• Health coverage
• Dental coverage
• Vision coverage
• Eligibility for various incentives including short-term incentive bonuses and equity-based awards for salaried roles.

What This Job Offers

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