Human Food Safety Scientist

11 - 15 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 10/09/17
Kalamazoo, MI
11 - 15 years experience
Biotech/Pharma
Salary depends on experience
Posted on 10/09/17

Zoetis Veterinary Medicine Research and Development (VMRD) seek an enthusiastic colleague for a challenging and fast-paced position in research and development of veterinary medicines in Kalamazoo, Michigan.  As an integral member of research and development project teams, the candidate will design and implement R&D programs to understand the absorption, distribution, metabolism, and elimination of veterinary pharmaceuticals in food producing animals with the goal of demonstrating the safety of food products in humans.  The candidate will collaborate extensively with bioanalytical, target animal safety, toxicology, pharmacokinetics, environmental, clinical, and regulatory scientists as part of a multidisciplinary team.

Responsibilities include:

  • Developing study designs and protocols for in vitro and in vivo studies.
  • Developing robust analytical methods to quantify drug residues in blood/plasma, tissues, and excreta at the low mg/kg to high ng/kg level.
  • Collaborating with other VMRD analytical groups and partners to provide high quality and seamless bioanalytical support for projects.
  • Serving as Study Director, Principal Investigator, or Contributing Scientist in GxP studies.
  • Conducting or monitoring internal studies or studies conducted at Contract Research Organizations. 
  • Writing or contributing to study reports and regulatory submissions.
  • Rapid response to regulatory, manufacturing, and product support queries globally.
  • Opportunity for participation in industry working groups.
  • Occasional domestic or international travel: usually ~5% annually depending upon nature and stage of project.

Minimum skills, education, attributes:

  • BS, MS, or PhD/DVM in chemistry, biochemistry, biology, pharmacy/pharmaceutics, or a related field.  PhD, DVM, or Pharm D is strongly preferred.
  • Post-graduate experience (PhD, DVM, or Pharm D) or 10 years of experience (BS or MS), preferably in the veterinary pharmaceutical or agricultural/food industry.
  • Experience developing and validating de novo analytical methods for new chemical entities in complex biomatrices by UHPLC-MS/MS, HPLC-UV/FL, radiometric, and other methods.
  • Experience in sample collection and preparation methodologies for complex matrices.
  • Demonstrated skill in scientific writing (protocols, reports, journal articles).
  • Excellent organizational and communication abilities (verbal and written English).
  • Ability to work in a collaborative and dynamic team environment in a global company.
  • Otherattributes/competencies: passion for problem solving, judgment, perseverance, planning, adaptability.

Desirable skills, education, attributes:

  • Experience conducting studies in a regulated environment (GLP, GCP).
  • Experience in laboratory automation and liquid-handling systems (e.g., Hamilton MICROLAB STAR).
  • Experience with e-notebooks (e.g., IDBS Biobook) and WATSON LIMS.
  • Experience conducting in vitro metabolism or in vivo ADME studies.
  • Experience working with radioisotopes (14C, 3H)

Familiar with global regulatory requirements (VICH/ICH, FDA/CVM, OECD, and country/regional requirements) for human or veterinary pharmaceuticals.

JR00002225

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