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Zoetis Veterinary Medicine Research and Development (VMRD) is seeking an enthusiastic colleague for a challenging and fast-paced position in Biologics Product Development in Kalamazoo, MI, at the Senior Scientist/Principal Scientist level.
The incumbent is responsible for the design and execution of pre-formulation, formulation & process optimization studies, including scale-up, manufacture of clinical supplies, and transfer processes to pilot/manufacturing facilities. The scientist in this position is also responsible for working collaboratively with multi-disciplinary teams, author technical and regulatory documents, leading / supporting organizational initiatives, assessing new capabilities / technologies. The selected individual is expected to have knowledge of protein biochemistry, lyophilization technology, protein stabilization approaches and familiarity with analytical techniques to characterize biopharmaceuticals.
The responsibilities for this role will include but not limited to:
- Design and conduct studies to characterize molecular and biophysical properties of peptides, proteins, monoclonal antibodies and other large molecules
- Design and development of parenteral biologic formulations (solutions, lyophilized products, and other dosage forms)
- Design and perform commercial process development studies for drug products by using expertise/knowledge of scale-down/scale-up principles
- Develop and optimize lyophilization-cycle
- Manufacture and supply formulations/drug product to non-pivotal and pivotal clinical studies
- Collaborate with and support pilot plant and manufacturing scientists for successful technology transfer for manufacture of pivotal/commercial drug product supplies.
- Author technical reports and contribute to regulatory documents
- Keep abreast of relevant new technologies & regulatory expectations/requirements
- Ensure work activities are aligned with relevant Quality, Regulatory and EHS requirements.
M.S (5+ years of relevant experience) or PhD (0-2 years of industrial experience) in Pharmaceutics or Pharmaceutical Sciences, Biochemistry, Chemical Engineering, Biomedical Engineering or related field with research focus on formulation related issues with monoclonal antibodies, proteins, peptides, or vaccines.
- Experience/ advanced knowledge of parenteral formulation development for biologics
- Advanced understanding of protein chemistry, degradation pathways, and general approaches for stabilization
- Advanced knowledge of biophysical techniques and ability to apply them for characterization and problem-solving during formulations development
- Ability to independently contribute from the bench
- Ability to coach, train and lead others in the design, execution and interpretation of experiments to drive the definition and optimization of formulations
- Good oral and written communication skills
Information about Zoetis:
Zoetis is a global animal health company dedicated to supporting customers and their businesses . Building on 60 years of experience, we deliver quality medicines, biopharmaceuticals and vaccines, complemented by diagnostic products and genetic tests and supported by a range of services. We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals in ways they find truly relevant.
Zoetis discovers, develops and manufactures a diverse portfolio of animal health medicines, biopharmaceuticals and vaccines designed to meet the real-world needs of veterinarians and the livestock farmers and companion animal owners they support. We are currently seeking to fill new positions to support our growing biopharmaceutical portfolio.Full timeRegularColleagueZoetis 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 [Register to View] 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 [Register to View] 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.