Scientist - Biopharmaceutical Pilot Registration Lab

Role Description

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 applicable experience with CHO cell culture work including cell separation, chromatography, filtration processes and in process analytical experience. Experience associated with upstream cell culture equipment for cell growth at a 50L to 2000L scale is desired.

The successful candidate will work with minimal supervision in a GMP-regulated environment, providing strong technical support and participating in multi-disciplinary teams in close collaboration with a range of scientists and manufacturing representatives across the organization.

The position is based in Lincoln (Nebraska, USA) with frequent interactions with colleagues and external partners located around the globe.

Position 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.
• Provide guidance, direction, and training for less experienced colleagues working in the VMRD Pilot Registration Lab

Education and Experience

• BS in Biological Sciences, BioSystems 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.

Technical Skills Requirements

• 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 the pilot lab setting.
• 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 including the ability to mentor less experienced colleagues
• Excellent written and verbal communication skills.
• Demonstrated record of working in a team environment

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.