Scientist - Biopharmaceutical Pilot Registration Lab

Role Summary

The Scientist in the Biopharmaceutical Pilot Registration Lab plays an essential role in the Zoetis biopharmaceutical program for veterinary medicine. As a scientist working in the Registration Lab, the individual should have technical knowledge of downstream processing for the final development, scale-up, and transfer to manufacturing for CHO expressed monoclonal antibodies. The successful candidate should have hands-on experience with recombinant protein production including centrifugation, chromatography and filtration processes. Experience associated with upstream cell culture equipment for cell growth at a 50L to 2000L scale is desired.

Responsibilities

• Operate and troubleshoot large scale equipment for purifying recombinantly-produced therapeutic proteins
• Develop process documentation, operating procedures, bills of materials, and protocols required for process transfer and validation. Author protocols, reports, and technology transfer documents that will support technology transfer within the company and to support regulatory filings for new product registrations. Maintain documentation and equipment records in accord with current GMPs.
• Collaborate with downstream process development to optimize the fit of the manufacturing to the pilot and commercial manufacturing facilities.
• Represent the pilot function on interdisciplinary project teams and serve as a liaison between product development teams and manufacturing functions. Contribute at the technical level to the direction of the team and provide information to support decision making in the realm of process scale up and transfer.
• Hands-on participation in the execution of GMP batches for any of the following unit operations:
  • downstream purification unit operations such as cross-flow filtration, centrifugation, process chromatography, precipitation, ultrafiltration, and sterile filtration
  • Support upstream activities of aseptic inoculation and growth of cultures through various vessels types and systems
  • supporting cleaning and steam-in-place activities for equipment
• Strive for continuous improvement by streamlining existing workflows.

Qualifications

• BS in biological sciences, biosystems engineering, chemical engineering or a related field with a minimum of 1-3 years of relevant experience.
• Practical competence in biopharmaceutical manufacturing process scale-up and tech transfer into commercial facilities.
• Experience in executing large scale biopharmaceutical production in a GMP-regulated environment.

Skills

• Demonstrated practical experience and knowledge in multiple technologies for biopharmaceutical drug substance final scale-up and transfer including cell separation (continuous centrifugation / filtration), tangential and normal flow membrane filtration, and chromatography. Knowledge of CHO cell culture is desirable.
• Working knowledge of the engineering principles covering drug substance process robustness and scale up.
• Familiarity with instrumentation and control systems that support GMP operation of pilot scale unit operations including the capability to perform advanced troubleshooting of the processes, equipment, and environment monitoring.
• Practical experience with automated control software and data capture systems such as SCADA, Delta V, and Unicorn.
• Knowledge of equipment specifications, qualification, operation, and maintenance within an FDA-regulated GMP environment
• Strong knowledge in GMP systems (change control, SAP, LIMS, etc.) is desirable
• A willingness to work on a flexible schedule in the task to monitor experiments and equipment including after-hours work.
• An ability to engage in work of a physical nature as encountered in pilot scale laboratory environments.
• Excellent aseptic technique.
• Experience with cGMPs, inspection, and compliance within biopharma manufacturing.
• Demonstrated track record working as an independent scientific expert on multiple concurrent programs.
• Knowledge of regulatory frameworks for veterinary biopharmaceuticals is desirable.
• Excellent organizational and people skills
• Excellent written and verbal communication skills.
• Demonstrated record of working in a team environment.