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Principal Scientist

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Kalamazoo, MI

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Position Summary **MEMBERS ONLY**SIGN UP NOW***. is the largest animal health company in the world with an industry-leading research and development team. We are seeking a talented senior pharmacokinetics-pharmacodynamics scientist to join our research and development team to develop novel protein therapeutics for veterinary use. This position will require a highly motivated and independent leader who can effectively collaborate with other team members to advance projects. The successful candidate will be primarily responsible for designing, conducting, analyzing, and interpreting in vivo PK/PD studies of protein therapeutics in multiple species in support of projects from early research through late-stage development. Responsibilities Independently design, conduct and analyze data for in vivo PK/PD, PK and TK studies in multiple veterinary species for large molecule (protein) therapeutics. Experience with small molecule pharmaceuticals is highly desirable. Serve as study director or principal investigator for in vivo PK, PK/PD or TK studies (GLP and non-GLP), including writing protocols and reports. Design and interpret studies to evaluate the immunogenicity of protein therapeutics. Provide PK and PK/PD modeling and simulation to help select lead candidates and optimize dose regimens Work collaboratively with interdisciplinary teams to prosecute studies and projects in line with the strategic direction of the team Present results to scientific teams, management, and regulatory agencies Write sections of regulatory submissions, respond to inquiries from regulatory agencies, and maintain knowledge of regulatory guidance documents Mentor other scientists Minimum Qualifications PhD in Pharmacology, Biochemistry, or related discipline with a minimum of 4 years of industry experience in PK/PD of small or large molecules. Demonstrated ability to design, analyze and interpret in vivo PK and PK/PD studies. Skilled in the used of PK and PK/PD analysis software such as WinNonlin or Watson. Experience in PK/PD modeling and simulation is highly desirable. Highly independent scientist with strong background in ADME and immunogenicity of protein therapeutics. Excellent written and oral communication skills Working knowledge of analytical methodology for large molecule and small molecule analyses, including ligand binding assays (immunoassays) and LC/MS/MS assays. Desirable skills Experience conducting GLP regulated studies Experienced with monitoring work at CROs Experience developing PBPK models, population PK models and/or evaluating PK variance in clinical populations Experienced with LIMS software, such as Watson. Full time Regular Colleague **MEMBERS ONLY**SIGN UP NOW***. 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 **MEMBERS ONLY**SIGN UP NOW***. Colleague Services at **** to request an accommodation. **MEMBERS ONLY**SIGN UP NOW***. 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 **MEMBERS ONLY**SIGN UP NOW***.. **MEMBERS ONLY**SIGN UP NOW***. 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 **MEMBERS ONLY**SIGN UP NOW***. 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 **MEMBERS ONLY**SIGN UP NOW***. domain of ****u201d. In addition, **MEMBERS ONLY**SIGN UP NOW***. does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with **MEMBERS ONLY**SIGN UP NOW***. via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, **MEMBERS ONLY**SIGN UP NOW***. will never ask candidates to make any type of personal financial investment related to gaining employment with **MEMBERS ONLY**SIGN UP NOW***..

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