Scientist / Senior Scientist, Pilot Plant Operations
Zoetis

Lincoln, Nebraska

This job has expired.


Role Description

Zoetis is the largest animal health company in the world with an industry-leading veterinary medicine research and development team. We are seeking a talented and motivated bioprocess scientist or bioprocess engineer to join our research and development team to complete final development, scale-up and transfer of new vaccines into the pilot plant in support of new product registration.

As a scientist working in the pilot plant, the individual should have technical knowledge in several unit operations which may include bacterial fermentation, production of conventional viral antigens, purified proteins, vaccine formulation, and/or lyophilization. Working knowledge of fermenters, single use bioreactors, and associated downstream processing equipment from a 50L to 1000L scale and/or formulation experience with adjuvanted vaccines, emulsification processes and lyophilization equipment at a 20 - 200L scale are highly desired.

The successful candidate will work with minimal supervision in a GMP-regulated environment in close collaboration with a range of scientists and manufacturing representatives across the organization. This job requires an independent thinker with demonstrated abilities to carry out assigned responsibilities and collaborate effectively with other team members. The position is based in Lincoln (Nebraska, USA) with frequent interactions with colleagues and external partners located around the globe.

Position Responsibilities:

  • Demonstrate technical knowledge and practical experience in several unit operations which may include bacterial fermentation, production of conventional viral antigens and purified proteins, and/or vaccine formulation, filling, and lyophilization utilizing the following types of equipment:
    • Upstream antigen production and protein expression in fermenters, bioreactors, single use bioreactors, cell culture matrixes.
    • Downstream processes and purification to include cell separation (continuous centrifugation / filtration), tangential and normal flow membrane filtration, and chromatography.
    • Vaccine preparation utilizing add / mix formulations, emulsification equipment, automated filling equipment, and lyophilization.
  • Contribute at the technical level with project teams and provide information to support decision making in the realm of process scale up and transfer.
  • Coordinate with cross-functional teams to execute plans and maintain deliverables.
  • Author protocols, reports, and technology transfer documents that will support validation and process transfer within the company and regulatory filings for new product registrations.
  • Maintain documentation and equipment records in accordance with current GMPs.
  • Champion strategic initiatives to evaluate and implement new technologies and equipment for process scale-up and registration.
  • Understanding of instrumentation and control systems that support GMP operation of pilot scale units, including the capability to perform advanced troubleshooting of the processes, equipment, and environment monitoring. Overview equipment specifications, qualification, operation, and maintenance within a GMP regulated environment.
  • Willingness to work on a flexible schedule in the task to monitor experiments and equipment including after-hours work.
  • Ability to engage in work of a physical nature, as encountered in pilot scale laboratory environments.
  • Strive for continuous improvement by streamlining existing workflows.
Organizational Relationships:
  • The position is located in the Pilot Lab within Biologics Process and Product Sciences.
  • The scientist will interact with peers and colleagues working in disciplines that include registration lab, pilot lab, cell line development, upstream development, downstream development, formulation development, quality operations, and regulatory affairs.
  • The position works in partnership with colleagues in Global Manufacturing Technologies to transfer developed processes to Global Manufacturing Supply for commercial production.
  • The individual is expected to form collaborative working relationships with project team leaders and line representatives within team settings.
  • The position may also interact with external parties including vendors, contractors, research collaborators, and contract manufacturers.
Education and Experience:
  • Minimum of a BS in Biochemistry, Molecular Biology, Biotechnology, Biopharmaceutical Sciences, Chemical or Biochemical engineering, or a related discipline. The successful BS candidate would be expected to have >5 years of industry experience with a BS degree, or 3-5 years industry experience with an MS degree, or >1 year industry experience with a PhD.
  • Proven practical competence in Biological and Biopharmaceutical manufacturing processes, scale-up and tech transfer into commercial facilities.
  • Technical knowledge and practical experience in key disciplines including, culture harvest technologies, cell separation methods, tangential filtration, and chromatographic purification techniques are required.
  • Experience/technical knowledge in several unit operations which may include bacterial fermentation, production of conventional viral antigens and purified proteins, and/or vaccine formulation, filling, and lyophilization.
Technical Skills Requirements:
  • Comprehensive hands-on practical experience in several unit operations which may include bacterial fermentation, production of conventional viral antigens and purified proteins, and/or vaccine formulation, filling, and lyophilization.
  • Applied experience in the equipment used for growth of cells, virus, bacteria, and expression of proteins, including multiple modalities of chromatography, crossflow and dead-end filtration.
  • Practical experience with automated control software and data capture systems such as SCADA, Delta V, and Unicorn.
  • Desired skill sets: knowledge of regulatory frameworks for veterinary biologicals and biopharmaceuticals, strong knowledge in GMP systems of change control, SAP, LIMS, Delta V, and/or understanding of mixing kinetics and Computational Fluid Dynamics.
  • Experience with cGMPs, inspection, and compliance within the pilot lab setting.
  • Technical writing skills in the areas of investigations, risk assessments, process validation, GMP requirements.
  • Knowledge of the regulatory (USDA, FDA, EMA) expectations for bioprocess design and technology transfer in alignment with the principles of GMP.
  • Demonstrated track record working as an independent scientific expert on multiple concurrent programs.
  • Excellent written and verbal communication skills.
  • Demonstrated record of working in a team environment.

Full time

Regular

Colleague

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.

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.


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