We are hiring for a remote PK Research Scientist 2
, Pharmacokinetics to support our Mattawan, MI site.
A PK Research Scientist 2
is responsible for providing support of studies aimed at determining the toxicokinetics (TK), toxicodynamics (TD), pharmacokinetics (PK), and pharmacodynamics (PD) of biologically active compounds or new candidate drugs in body fluids and tissues of laboratory animals and/or humans. Developing and executing protocols/plans in accordance with company Standard Operating Procedures (SOPs) and industry regulatory guidelines (GxP).
- Develops training materials and provides training for the kinetic analysts and supporting functional areas staff on the compliant use of kinetic software applications.
- Plans, designs, analyzes, interprets and reports toxicokinetic (TK)/toxicodynamic (TD) and pharmacokinetic (PK)/pharmacodynamic (PD) data for GxP and non-GLP studies.
- Prepares TK/TD/PK/PD components of study reports.
- Provides accurate and timely project status/updates to management and external customers.
- Reads, understands and follows SOPs, safety requirements, regulatory guidelines and company policies.
- Interprets and presents project-related study results to the Sponsor/management as appropriate.
- Demonstrates commitment to quality and animal welfare.
- Demonstrates a willingness to perform additional work as assigned by management and as a part of the individual's development plan.
- Develops, modifies and/or optimizes existing/new TK/TD/PK/PD methods, techniques or procedures.
- Assists with training and developing employees.
- Expected to work independently, participate in process improvement initiatives and may function as a Principal Investigator or Individual Scientist.
- Other duties as assigned.
- Ph.D. or Master's/Bachelor's degree in a related field and 7+ years of relevant experience; contract research organization experience preferred.
- An equivalent of education and experience may be accepted as satisfactory.
- Expert knowledge of GxPs and applicable industry guidance documents.
- Working knowledge of TK/TD/PK/PD theory.
- Experience with PK related software including but not limited to: WinNonlin* and SigmaPlot*
- Basic familiar with Microsoft Office Suite.
- Computer skills, commensurate with Essential Functions including ability to learn a validated system.
- Ability to work extended hours beyond normal work schedule to include but not limited to: evenings, weekends, extended or extra shifts, sometimes on short notice.
- Ability to work under specific time constraints.
Employment Type: Full Time
Years Experience: 5 - 10 years