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Position Summary
Zoetis is the largest animal health company in the world with an industryleading research and development team. Zoetis Veterinary Medicine Research and Development Biologics Analytical Sciences in Kalamazoo MI is seeking an assay development professional at the Senior Scientist/Principal Scientist level. This position requires a highly motivated and independent contributor who can effectively collaborate with other team members to develop fit for purpose analytical methods advance projects develop program strategies and answer questions from regulatory authorities. The candidate must be highly motivated to contribute to the characterization of biopharmaceutical products. Agility in data analytics is highly preferred. Selfmotivation excellent problemsolving skills and communication and an ability to work independently and within a group are essential to this role.
Responsibilities
Responsibilities include but are not limited to the following:
* Lead design and conduct laboratory experiments including analytical method development validation and transfer. Primary assays will be HPLC mass spectrometry electrophoresis spectrophotometric and microplate assays.
* Represent Analytical Sciences at project team meetings and provide analytical support for antigen or antibody characterization in support of process development and establishment of analytical methods for release testing.
* Perform analytical methods necessary for the characterization and release of active biological ingredients vaccine and biopharmaceutical products.
* Design set up and conduct stability and other hypothesis driven studies.
* Trend and report method/critical reagent performance data.
* Develop and/or adopt new analytical technology as appropriate to advance programs with significant analytical and timeline challenges.
* Documentation reporting and communication of results in electronic laboratory notebooks technical reports PowerPoint presentations and oral presentations.
* Interface with other scientists in a variety of technical disciplines including process development formulation development clinical operations quality control quality assurance discovery and manufacturing.
* Have a basic understanding of and utilize the statistical methods employed in process control and method with Statistics group to design experiments and report data.
* Assist in the preparation and writing of regulatory filings.
Minimum Qualifications:
* PhD or BS/MS in chemistry biochemistry engineering biology or other related discipline at least 13 years (PhD) or 8 years (MS or BS) experience preferably in the biopharmaceutical or vaccine industry.
* Motivated selfstarter with excellent oral and written communication skills
* Experience with HPLC mass spectrometry electrophoresis
* Experience in developing and validating biopharmaceutical analytical methods
* Prepare comprehensive analytical reports and presentations conveying findings to both technical and nontechnical stakeholders.
* Strong problemsolving skills and a proactive attitude toward process improvement
Desired Qualifications:
* Proficiency in data analytics tools such as JMP Tableau and Minitab with the ability to manipulate analyze and visualize complex data sets
* Individual contributor with experience in multiple analytical techniques (HPLC mass spectrometry immunoassays CGE cIEF) used to assess quality attributes of biopharmaceutical or vaccines products in development.
* Familiarity with peptide mapping by LCMS/MS (UHPLC and nanoLC) intact mass analysis MS/MS for protein and carbohydrate structural elucidation
* Skills and experience in statistical analysis of assays design of experiments (DOE) technical problem solving and continuous improvement.
* Experience with biopharmaceutical development and product licensure.
* Familiarity with biopharmaceutical manufacturing processes including cell culture purification and formulation
* Knowledge of the regulatory requirements (ICH FDA EMA USDA) that apply to the development of tests for products tested under GMP release.
Full timeRegularColleagueAny 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 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 site or (2) via email to/from addresses using only the Zoetis domain of @. 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.Required Experience:
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Full-Time