Associate Director / Sr. Principal Scientist - Downstream Process Development
Zoetis

Job Info

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Role Description

The Senior Principal Scientist in downstream bioprocess development (DSP) plays a vital role in the Zoetis biopharmaceutical and vaccine strategies for veterinary medicine. The successful applicant will be a team leader overseeing the development of purification processes in support of global product development and GMP (Good Manufacturing Practice) manufacture of veterinary monoclonal antibodies (mAb) derived from mammalian cell culture, in the development of veterinary vaccines, and in the development of recombinant proteins for use as either therapeutics or vaccines. The applicant should provide strong technical, strategic, and organizational leadership through management of a portfolio of programs for DSP biopharmaceutical and vaccine programs. This is a people manager role, with responsibility for leading and developing a team of scientists working in downstream process development. The Senior Principal Scientist is expected to be an expert in the purification of monoclonal antibodies and recombinant proteins as well as in the preparation of antigens to serve as veterinary vaccines with the ability to lead and train individuals working in these disciplines. Late-stage product development, process characterization and tech transfer knowledge and experience are preferred. The Senior Principal Scientist is expected to work and/or lead project teams in partnership with colleagues in cell culture development, bacteriology, virology, formulation development, and bioanalytical science. The position is based in Kalamazoo (Michigan, USA) with frequent interactions with colleagues and external partners located around the globe.

Position Responsibilities

• Be a champion of innovation to ensure Zoetis leadership in DSP science. Apply comprehensive skills and knowledge in the discipline gained through experience in developing and optimizing robust, economical purification processes for monoclonal antibodies, recombinant proteins, and vaccines.
• Be able to train new colleagues in DSP bench-scale techniques and to design, develop, and transfer processes to pilot and manufacturing colleagues for implementation in a commercial environment.
• Serve as a process expert in the execution of process characterization studies (including DOE approaches) to identify and define proven acceptable parameter ranges and normal operating ranges. Understand and design viral inactivation/removal processes and work with vendors as necessary to preform viral clearance studies.
• Serve as a subject matter expert for chromatography and filtration (cross-flow and dead-end) approaches as they pertain to both therapeutic proteins and vaccines.
• Author and/or review protocols, study reports, and technology transfer documents that will support technology transfer within the company or to contract manufacturers and to support regulatory filings for new product registrations.
• Represent DSP and Process Development on interdisciplinary project teams. Contribute at the strategic level to the direction of the team and guide decision making in the context of DSP or process development as a whole.
• Strive for continuous improvement by streamlining existing workflows to increase the volume of DSP work performed by the function while identifying opportunities to shorten the timelines for process development.
• Coach and mentor junior Zoetis colleagues and provide direction to contingent workers and contractors providing support for DSP operations.
• Perform antigen purification and/or viral concentration to support mono- and multivalent vaccine development. Experience with protein modification and/or detoxification of toxins is highly desirable. Experience with isolation of inclusion bodies and protein folding is highly desirable.
• Maintain electronic laboratory notebooks and records in accord with scientific protocol and applicable Standard Operating Procedures.

Organizational Relationships

• The position is located in the Bioprocess Development line within the bioprocess and products sciences team. The Senior Principal Scientist will interact with peers and colleagues working in disciplines that include cell culture, cell line development, bacteriology, virology, formulation development, and bioanalytical sciences.
• The position works in partnership with colleagues in Zoetis Global Therapeutic Research and Global Biological Research to develop new biopharmaceutical and biological candidates.
• Interaction with colleagues working in regulatory affairs for dossier preparation.
• Partnership with colleagues in Pilot operations and manufacturing to ensure efficient technical transfer of new candidates into GMP manufacturing operations.
• The Senior Principal Scientist is expected to form collaborative working relationships with project team leaders and line representatives within team settings.
• The position also interacts with external parties including vendors, contractors, research collaborators, and contract manufacturers working in the DSP field.

Education and Experience

• MSc, or PhD in Biochemistry, Biotechnology, chemical or biochemical engineering, or a related discipline with at least 7-10 years of experience in DSP operations.
• First-hand knowledge of the regulatory requirements (FDA, USDA, EMA) that apply to the development of purification processes for GMP manufacturing of biopharmaceutical and biological products.
• Demonstrated track record as a leader of both projects and people.

Technical Skills Requirements

• Strong theoretical knowledge in the scientific disciplines that support downstream processing such as protein chemistry, biotechnology, and biochemistry.
• Comprehensive hands-on practical experience in the tools used for downstream processing including multiple modalities of chromatography, cross-flow and dead-end filtration, cell disruption and removal, automated liquid handling techniques, and supporting analytical techniques including UV-Vis spectrophotometry, gel electrophoresis, HPLC, and protein assays.
• Practical experience with automated chromatography software such as Unicorn (AKTA Explorer, Pure, Avant and/or Pilot).
• Demonstrated track record in developing robust, scalable, purification processes for monoclonal antibodies and/or recombinant proteins.
• Excellent written and verbal communication skills.
• Demonstrated record of working in a team environment with highly developed interpersonal relationship skills.

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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