Senior Scientist/Principal Scientist – Biologics Analytical Sciences

Position Summary
Zoetis is the largest animal health company in the world with an industry-leading 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.  Self-motivation, excellent problem-solving 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 development. Partner 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 1-3 years (PhD) or 8+ years (MS or BS) experience preferably in the biopharmaceutical or vaccine industry. 

* Motivated self-starter 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 non-technical stakeholders.

* Strong problem-solving 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 LC-MS/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 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 h