Specialist, Clinical Biologics

Role Summary

Specialist, Clinical Biologics in the Clinical production team within Biopharmaceutical Development. Build broad knowledge of bioprocessing in a cGMP environment, contribute to process development, and gain experience in cell culture, purification, and critical support activities. Shift-based schedule, Monday through Friday, with potential 6:00 AM–3:00 PM or rotating 10-hour shifts.

Responsibilities

• Operates and trains others on manufacturing equipment including incubators, bioreactors, depth filtration skids, chromatography skids, single-use mixers, centrifuges, equipment cleaning/sanitization, washers, autoclaves, tanks, and in-process testing instruments.
• Monitors process parameters, contributes to investigations, troubleshoots during processing, and recommends solutions.
• Acts as Subject Matter Expert in unit operations to improve quality, ensure safety, and drive process efficiency and accuracy.
• Supports process improvement initiatives and authors or revises standard operating procedures.
• Reviews executed Production Records for accuracy and completion.
• Utilizes MS Office tools and AZ enterprise systems.

Qualifications

• Education: Associates degree in a science field with 4+ years' experience OR High School Diploma with 6+ years' experience.

Skills

• Upstream:
  • Proficient in cell culture operations such as Biosafety Cabinet Operation, Cell Banking, Bioreactor Operations, Aseptic Technique, and Centrifuge Harvest Operations.
  • Ability to work in a team environment and lead peers.
  • Excellent verbal and written communication skills.
• Support Services:
  • Proficient in preparation and filtration of production-scale buffers and media solutions.
  • Proficient in operation of area-specific production equipment (parts washers, autoclaves, fixed/portable stainless-steel tanks).
  • Ability to work in a team environment and lead peers.
  • Excellent verbal and written communication skills.

Education

• Associates degree in a science field with 4+ years of experience or High School Diploma with 6+ years of experience.

Additional Requirements

• Demonstrated flexibility and willingness to adapt work practices.