About MPI Research: MPI Research, with global headquarters in Mattawan, Michigan, provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries. Scientific knowledge and experience, integrity, trust, teamwork, and dedication to strong and enduring Sponsor relationships are the defining attributes that characterize MPI Research as a high-performance, high-quality organization that is committed to bringing safer and more effective products to the world. Learn more about how we can exceed your expectations at www.mpiresearch.com.
A Senior Scientist supporting the Translational Imaging Center (TIC), which is aligned with the Drug Metabolism Pharmacokinetics (DMPK) Division of MPI Research, is responsible for developing and/or validating methods and/or procedures to support required radiopharmaceuticals/radiotracers, to either quantify/synthesize chemical entities, or prepare formulated test articles or supporting compounds, or conduct studies of chemical compounds in vitro or in vivo, according to applicable Standard Operating Procedures (SOPs), study protocols and/or GxP regulations. The individual in this role serves as a key point of contact with Sponsors, colleagues, and represents MPI Research through active engagement within the scientific community, including regular meeting attendance and publications/presentations. A Senior Scientist is expected to work independently, may supervise others, and may function as a Principal Investigator, Contributing Scientist, and/ or Study Director.
(Duties & Responsibilities – purpose of the function and result to be accomplished) include but are not limited to those listed:
- May be responsible for supervisory functions in accordance with the organization’s policies and applicable laws to include interviewing, hiring, training, and developing employees; planning, assigning and directing work; appraising performance and completing annual performance review on or before due date; rewarding and disciplining employees; addressing complaints and resolving problems.
- Leads efforts to establish methods to produce novel chemical entities/radiopharmaceuticals/radiotracers, and/or leads method development/technology transfer to produce established entities and supporting compounds.
- Leads others in the completion of method validation studies and/or formulation procedures.
- Maintains applicable laboratory equipment and operations according to industry standards and regulatory guidelines as applicable.
- Leads problem-solving efforts for technical and/or regulatory issues.
- Documents procedures and materials in compliance with GxP standards, as applicable.
- Operates laboratory instruments, including their respective software applications; may function as Subject Matter Expert (SME) and/or Application Owner (AO).
- Assists in the completion of laboratory investigations and quality observations, as needed.
- Recognizes method and/or data issues, and communicates them to management and/or Sponsors to minimize study impact.
- Implements new technology and or platforms, leading the selection and developing case arguments for investment.
- Promotes industry best practices.
- May oversee sample analysis and validation studies as a Principle Investigator, Study Director, or Contributing Scientist, as assigned.
- Bachelor’s/Master’s degree in a relevant field and 10-15 years of relevant experience; or
- Doctoral degree in a relevant field and 5-10 years of relevant experience.
- Proficient using laboratory software applications (i.e., LIMS and data acquisition software).
- Demonstrated ability to apply knowledge and skills in a collaborative research environment.
- Demonstrated competence in the preparation of peer-reviewed scientific publications and presentations.
- Excellent interpersonal written and oral communication skills and the ability to interact directly with internal and external scientists.
- Familiarity with global regulatory guidance (e.g., Food and Drug Administration (FDA), Organization for Economic Co-operation and Development (OEDC), European Medicines Agency (EMA), International Council for Harmonization (ICH) as applicable for scientific discipline
- Working knowledge of GxPs and industry guidance documents.
- Ability to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended shifts and/or extra shifts, sometimes on short notice.
- Familiarity with Microsoft Office Suite.
- Ability to work under specific time constraints.