Sr. Research Scientist – DMPK
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Newark, DE 19702
This staff member is primarily responsible for independently performing and managing Studies either as a Principal Investigator or Study Director. S/he will take the lead in the development of Study protocols, evaluation of alternate methodologies, study set-up, and analysis and evaluation of results either directly or by coordinating with the other team members. As Principal Investigator, incumbent will lead and/or contribute to novel techniques and analytical enhancements to improve processes and be informed of leading edge techniques that can be implemented to enhance project support.
- Independently understand, recognize and initiate/prepare draft/final study protocols and SOPs in assigned area:
- Bioanalytical – Develop new LC-MS/MS bioanalytical methods, troubleshoot analytical issues, analyze results, contribute to developing leading edge LC MS/MS methodologies and techniques for bioanalytical assays, and develop, validate and run sensitive, reliable and efficient LC-MS/MS assays for in vivo and in vitro ADME assessment.
- In-vivo ADME – Validate unique scientific methods, assays, techniques, reports, etc. Perform Studies directly or by coordinating/organizing, including in-life phase of study.
- Biotransformation – Plan, design and conduct in vitro and in vivo metabolism studies, including metabolite profiling and identification studies, analyze biological samples using LC/MS/RFD, interpret results of LC/MS, and propose structures of metabolites and metabolic pathways
- Pharmacokinetics – Develop, validate and run sensitive, reliable and efficient LC/MS/MS assays for TK/PK assessment
- Validate unique scientific methods, assays, techniques, etc.
- Coordinate with client and internal resources to plan, design and conduct Studies.
- Prepare and/or review and understand Study protocols.
- Simultaneously design and execute multiple projects and experiments for the assigned area
- Coordinate study activities to ensure quality and efficiency.
- Perform high-volume sample analysis and/or data analysis, data QC, data summaries, and data interpretation.
- Evaluate significance of data and report findings.
- Prepare draft/final Study protocols, and Study summaries and/or reports.
- Maintain schedule of projects and timelines, including databases and Master Schedule
- Communicate project timelines, status, data, reports, and inquiries to internal departments and/or external client/collaborators, effectively addressing any issues that may arise.
- Lead team in method development and validation.
- Collaborate with internal departments and/or external clients/etc. to maintain timely analysis and results, assessment, and technology transfer.
- Pro-active, strategic project planning and organization.
- Manage multiple projects at the same time.
- Set-up, utilize, and maintain routine and complex lab instrumentation
- Maintain the proper level of regulatory compliance for each study, preparing QA-related documents and addressing QA-related findings.
- Ensure that regulations and SOPs are followed in all activities.
- Maintain tools, computer programs, and SOPs required for studies.
- Maintain an awareness of the current state of the science in their discipline and suggest improvements when possible.
- Research literature and external sources, and identify new techniques and procedures that strengthen QPS’ capabilities.
- Update database(s), or provide information as case may be, on a daily basis
- Supervise, train and/or mentor junior scientists.
- May prepare formulations for studies.
- Prepare materials for presentations and publications.
- Follow safety precautions.
Competencies (“soft skills”, traits, behaviors – i.e., adaptability, analytical thinking, tenacity, initiative, results orientation)
- Creative thinking
- Conceptual thinking
- Results orientation
- Concern for standards
- Self-development orientation
Knowledge / Skills / Abilities (i.e., knowledge of GLP regulations, operation of lab equipment, mathematical ability)
- Understanding of experimental design and planning associated with assigned area, as well as data collection and analysis software.
- Demonstrated supervisory and managerial ability.
- Demonstrated knowledge of GLP regulations.
- Demonstrated skills associated with assigned area:
- Bioanalytical – experience operating LC-MS/MS, LC-UV/FLU/ECD, GC-MS, GC-FID/NPD/ECD instrumentation
- In vivo ADME – animal cannulation, dose administration, bleeding ability and experience working with radiolabel studies a plus
- Biotransformation – thorough understanding of MS/MS experiments
- Pharmacokinetics – understanding of preclinical pharmacokinetics
- Proven ability to successfully work in a team environment.
- Excellent oral and written communication skills.
- Ability to make independent decisions.
- Familiarity with LIMS and databases.
Education / Experience (minimum degree level and/or minimum number of years experience – including field of study and/or experience)
- Doctorate level degree in Analytical Chemistry, Biochemistry, Pharmacology or related science, with a minimum of three (3) years direct experience, OR
- Masters level degree in same disciplines with eight (8) or more years of relevant experience, OR
- Bachelors level degree in same disciplines with a minimum of eleven (11) or more years of relevant experience.