Senior Scientist – Biologics Analytical Development

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 Lincoln, NE is seeking an assay development professional at the Senior Scientist level.  This position will require a highly motivated and independent contributor who can effectively collaborate with other team members to advance projects, develop program strategies and answer questions from regulatory authorities.  The successful candidate will be primarily responsible for development and validation of HPLC, mass spectrometry, qPCR and/or ELISA methods for vaccines or biopharmaceuticals in support of projects from early research through late-stage development and transfer into QC.

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, qPCR and/or ELISA. May include other analytical methods such as CGE and/or iCE as needed to support projects.

* 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 technical 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 0-2 years (PhD) or 8+ years (MS or BS) experience preferably in the biopharmaceutical or vaccine industry. 

* Excellent oral and written communication skills

* Experience with HPLC, mass spectrometry, qPCR and/or ELISA

Desired Qualifications:

* PhD in Chemistry, Biochemistry, Engineering, Biology or a related discipline with a minimum of 3 years of post-graduate experience in HPLC, mass spectrometry, qPCR and/or ELISA method development in an industrial laboratory setting.

* BS/MS with 10+ years hands-on industry experience in HPLC, mass spectrometry, qPCR and/or ELISA

development in an industrial laboratory setting.

* Individual contributor with experience in multiple analytical techniques (HPLC, immunoassays, CGE, cIEF, qPCR) used to assess quality attributes of biopharmaceutical or vaccines products in development.

* 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. 

* Knowledge of the regulatory requirements (FDA, EMA, USDA) that apply to the development of tests for products tested under GMP release.

Full time

Regular

Colleague

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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 ori