Principle Scientist Biopharmaceutical Process and Technical Transfer Details

Principle Scientist Biopharmaceutical Process and Technical Transfer

Zoetis - Lincoln, NE

Employment Type : Full-Time

Position Summary

Enable Zoetis’ mission to serve customers by supporting robust processes and innovative technologies using our scientific and engineering expertise.

The role of the downstream bioprocess scientist will provide technical support for complex equipment and Biopharmaceutical processes. Experience in design, qualification, operation, maintenance and improvement of biopharmaceutical equipment and processes will be required to support day to day manufacturing activities as well as to lead process improvement projects and technical transfers. The candidate is expected to work hands-on while providing strong technical leadership and partnering with manufacturing, quality, supply chain, equipment engineering, research and development, and process scientists to produce clinical supply and work toward commercial facility licensure. The position will require a high degree of autonomy in the discipline and work with colleagues in cell culture, bacteriology, virology, formulation and bioanalytical science. To be successful this position will require expertise in chromatographic and filtration processes for purifying proteins and a working knowledge of related bioprocessing operations.

Position Responsibilities

• Applies advanced and diverse science and engineering principles to the design and implementation of major system modifications, process and/or capital projects.
• Support clinical and commercial tech transfers of late stage Zoetis products from laboratories and across manufacturing facilities.
• Represent manufacturing and provide input to development teams
• Support cell culture and purification drug substance processes
• Develops, organizes, analyses and presents interpretation of results for operational issues of significant scope and complexity
• Equipment / Process knowledge to perform complex troubleshooting of process, equipment failures or malfunctions and/or the development of technical assessments
• Conduct process monitoring and provide technical troubleshooting using sophisticated digital tools (PAT). Using this analysis, identify and implement process improvements that lead to yield and capacity improvements.
• Serve as a process expert of Biopharmaceutical operations and processes such as single use technologies, Media / Buffer Prep solutions, Inoculation, Bioreactors, Centrifugation, Chromatography and Tangential Flow Filtration
• Author protocols, study reports, SOPs and other documents in support of process changes/optimization.
• Mentor junior colleagues and provide direction to manufacturing colleagues and contractors
• Provide technical guidance and lead investigations for process related deviations, change control and operational excellence projects
• Demonstrate project management skills and application of concepts.
• Work within a cGMP environment and maintaining regulatory and quality compliance.
• Experience in investigation of deviations, development of corrective and preventive actions and generation and implementation of change controls.

Education and Experience

Basic Qualifications:

• Master’s degree and 10 years of Biopharmaceutical Process Development experience

Or

• Bachelor’s degree and 15 years of Biopharmaceutical Process Development experience

Preferred Qualifications:

• Master’s or PhD degree in Biochemistry, Biology or Biochemical Engineering
• 10+ years Biopharmaceutical Process Development experience related to biochemical engineering and/or protein biochemistry, scale-up principles, and manufacturing of Biopharmaceuticals (cGMP

Technical Skills and Competencies Required :

• Background in biopharmaceutical tech transfer into commercial facilities
• In depth knowledge of cell culture and purification processes/ equipment
• Demonstrated leadership skills and decision-making experience
• Strong academic and applied experience in science and / or engineering, troubleshooting, and problem solving
• Independently motivated with successful ability to multi-task and work in teams
• Excellent written and verbal communication with experience with technical writing and presentations
• Process optimization and change control experience.
• In depth knowledge of USDA, FDA and EU regulatory systems desired.
• Strong technical/analytical skills and possess a high degree of personal motivation.
• Strong commitment to product quality, continuous improvement and working knowledge of RFT (Right First Time) and Lean principles.
• Strong commitment to customer service.

Physical Requirements

• Lifting
• Sitting
• Travel to domestic and international sites may be required <10%
• Standing
• Walking
• Gowning into production areas
• Work some weekends due to experimental designs

Full time

Regular

Colleague

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.