- Serve as Senior Scientific team member with overall responsibilities of the scientific and operational management of bio analytical programs supporting a variety of early to late stage PK/PD studies. Provide support and direction for one or more functional areas of expertise critical to the business objectives of the company.
- Responsible for mentoring and management of more junior staff across multiple programs, scientific areas and client interactions.
- Functioning independently as the Principal Investigator and technical expert, develop, perform, and troubleshoot bioanalytical laboratory experiments, tests, and procedures within accepted regulatory compliance.
- Function as the primary contact for the planning and execution of Sponsor interaction related to research and method development, and for the design, scheduling, conduct and reporting of studies.
- Ensure raw data is accurate, complete and in appropriate order to meet protocols, SOP specifications, and GLP requirements.
- Prepare high quality final reports appropriate for the study including method development, qualification, and sample analysis reports.
- Provide oversight of the laboratory and mentor scientific staff in areas such as protocol interpretation, method development and refinement, study-related problem resolution, and technique validation. Provide scientific expertise in study conduct, design, and interpretation.
- Perform advanced troubleshooting on analytical instrumentation including chromatography and mass spectrometry systems.
- Direct the development and communication of departmental systems, SOPs, policies, and procedures.
- Attend and present at scientific meetings.
- Perform all other related duties as assigned.
- Education: Bachelor's degree (B.S./B.A.) or equivalent in a scientific related discipline. Related Master's degree (M.S./M.A.) or Ph.D. preferred.
- Experience: Minimum of 6 years related experience in the contract research, academic, or pharmaceutical industry.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Certification/Licensure: Certification as appropriate for specialty preferred.
- Other: Full understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate. Knowledge of applicable international guidelines for all types of studies. Demonstrate leadership skills as they pertain to intra- and interdepartmental initiatives, Sponsor interactions, and business development. Effective written and verbal communication skills. Ability to handle multiple projects, prioritize work and meet deadlines. Proficiency in the use of standard software including Microsoft Excel, Word, PowerPoint, etc. and analytical instrumentation software
Equal Employment Opportunity