Full Job Description
Act as Study Director
Assist in the preparation of study proposals.
Prepare draft/final study protocols for studies.
Perform experiments and/or data analysis, data QC, and data interpretation.
Evaluate significance of data and report findings.
Prepare study summaries and/or reports.
Coordinate study activities to ensure quality and efficiency.
Conduct pro-active, strategic project planning and organization.
Plan and maintain schedule of projects and timelines.
When assigned as Study Director, work with sponsor and internal resources to plan, design, and coordinate conduct of studies.
Communicate project timelines, status, data, reports, and inquiries to internal departments and/or external client/collaborators, effectively addressing any issues that may arise.
Collaborate with internal departments and/or external clients/collaborators to maintain timely sample analysis and results, assessment, and technology transfer.
Maintain the proper level of regulatory compliance for each study, preparing quality-related documentations and addressing quality-related findings.
Develop and run robust and sensitive assays for in vitro ADME assessment.
Simultaneously handle new assays development and routine transporter projects.
Manage multiple projects at the same time.
May qualify unique scientific methods, assays, techniques, etc.
Set-up, utilize, and maintain routine lab instrumentation, such as, refrigerators, freezers, centrifuges, liquid scintillation counters.
Maintain tools, computer programs, and SOPs required for studies.
Research literature and external sources, and identify new methodologies and procedures that strengthen company capabilities.
Update database(s), or provide information as case may be, on a daily basis
Supervise, train and/or mentor junior scientists.
May prepare materials for presentations and publications.
Ensure that regulations and SOPs are followed in all activities.
Follow safety precautions.
Provide leadership through effective goal setting, delegation, hands-on involvement and communication
Other duties as assigned
Ph.D. in Biochemistry, Biology, Toxicology or Pharmaceutical Sciences or other related scientific discipline AND a minimum of three (3) years of relevant experience, OR combination of Masters level degree in same disciplines with six (6) or more years of relevant experience, OR Bachelors level degree in same disciplines with a minimum of eight (8) or more years of relevant experience.
Proven ability to successfully work in a team environment.
Ability to make independent decisions.
Hands-on experience in in vitro ADME assays.
A thorough understanding of biohazards and safety requirements, including handling and mastery of appropriate protocols.
Demonstrated proficiency at operating relevant laboratory equipment.
Proven ability to recognize technical problems, identify unexpected results and take action (i.e., deviations from scientific patterns and variability in experimental results).
The ability to collect and organize data, and to recognize problems that could impede completion of studies according to the study protocols.
Proficiency in common software packages, including Microsoft Office and GraphPad Prism.
Excellent oral and written communication skills.
Organizational skills with great attention to detail
Ability to effectively present information to customers, clients, and internal staff members
Working knowledge of GLPs and other regulatory and safety standards.
Previous supervisory experience
Pharmaceutical industry experience
Experience with primary hepatocytes is highly desired.
Experience with broad principles of biostatistics is highly desired.
Previous drug discovery experience is preferred.
Experience with laboratory automation is desired.
Position requires sitting and/or standing for long periods of time
Ability to lift up to 25 pounds
Ability to work in a fast-paced environment and meet time and quality-based objectives
Travel up to 5% of the time
Occasionally required to work evenings, weekends
Daily contact with dry ice and liquid nitrogen vapor
Contact with human biological specimens and sharps on a daily basis
HepB vaccination is required (other vaccination or testing as recommended)
Proof immunization or waiver is acceptable
The Company is an AA/EEO/Veterans/Disabled Employer.