Specialist, Clinical Biologics

As a specialist in the Clinical production team within Biopharmaceutical Development, you’ll build broad knowledge of bioprocessing in a cGMP environment to launch your career in the biopharmaceutical industry. In this role you will take an adaptable, science driven approach to everything you do.  You will become an integral part of process development, accelerating product candidates into the clinic and gaining knowledge and experience in cell culture, purification and critical support activities. Under the supervision of highly trained personnel, you will gain the process knowledge and skillsets to perform large scale clinical development activities.  You will join a collaborative and driven team in a world class biopharmaceutical company. This role follows a shift-based schedule, offered Monday through Friday. Team members may work either a 6:00 AM–3:00 PM shift or a rotating 10-hour shift, depending on business needs.

Main Duties & Responsibilities:

• Operates and serves as a trainer for operation of manufacturing equipment such as: incubators, stainless steel and disposable single-use bioreactors, depth filtration skids, chromatography skids, single-use mixers, centrifuges, cleaning/sanitization of equipment, washers, autoclaves, tanks and in-process testing instruments.

• Monitors process parameters,contributes to investigations, troubleshoots during processing,and recommends potential solutions.

• Serves as the “Subject Matter Expert” in unit operations to improve quality, ensure safety, and drive process efficiency and accuracy.

• Support process improvement initiatives and authors or revises standard operating procedures accordingly.

• Reviews executed Production Records for accuracy and completion 

• Ability to utilize MS Office tools and AZ enterprise systems

Education & Experience Requirements:

• Bachelor's degree (preferred) OR Associates degree in a science field with 4+ years' experience 

Required 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 with others in a team environment and lead a team of peers

• Excellent verbal and written communication skills

Support Services 

• Proficient in preparation and filtration of production scale buffer and media solutions.

• Proficient in the operation of all area specific production equipment such as partswashers, autoclaves, fixed and portable stainless-steel tanks, etc.

• Ability to work with others in a team environment and lead a team of peers

• Excellent verbal and written communication skills

Desired Skills:

• Dynamic individual with the ability to communicate and engage others.

• Independent and self-starting. Ability to work with minimal supervision.

• Demonstrate a high level of drive and initiative.

• Logic and decision-making abilities, critical thinking and troubleshooting skills.

• Demonstrate leadership, organization and time management skills.

• Demonstrate flexibility and willingness to change ways of working