Purpose: 

• Performs functions associated with cGMP manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components, and final materials.
• Completes batch documentation accurately and thoroughly, while adhering to the required quality and safety standards, and in a productive, cost-effective manner.
• Supports operations & troubleshooting efforts during course of shift work to ensure adherence to schedule and production plan.

Major Responsibilities:

Operations and Technical

• Adhere to cGMP and safety requirements
• Executes manufacturing operations to perform operations including but not limited to equipment cleaning and set up as well as stream specific operations like:
  • Upstream: Vial Thaw, Inoculation, Cell Culture and Recovery
  • Downstream: Chromatography, Filtration, Ultrafiltration, Final Filling
  • Central Service: Buffer/ Media Preparation, Autoclave, Glasswash and cleaning processes, Sampling of raw materials.
• Carry out daily tasks as assigned by Lead Biotechnologist or Manufacturing Supervisor
• Accurately completing documentation on time, accurately and legibly.
• Maintains inventory levels to minimize distress
• Ensures training is complete and current.
• Responsible for overall plant upkeep during the shift.
• Reports any anomalous processing events to Lead Biotechnologist or Manufacturing Supervisor timely.

Safety

• Adhere to and support all EHS & E standards, procedures, and policies.

Quality

• Accurately completes documentation on time, accurately and legibly
• Reviews documentation for the completeness and accuracy.
• Ensures that all batch related document errors are resolved in a timely manner
• Support in preparation for regulatory audits and inspections

Schedule

• Adheres to production schedule
• Escalates to Lead Biotechnologist or Manufacturing Supervisor in events of unplanned downtimes.