Research Scientist – DMPK
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Newark, DE 19702
This staff member will independently manage one or more studies as Principal Investigator or Study Director. As the Principal Investigator, incumbent will fill the role of Technical Leader, and be responsible for completing portions of/entire, projects, and providing quality and timely results, as well as collaborating and communicating with Clients, QPS management, and external resources.
o Independently understand, recognize and initiate/prepare draft/final study protocols and SOPs in assigned area:
o Bioanalytical – Develop and run robust and sensitive LC-HRMS or LC-MS/MS assays for in vivo and in vitro ADME assessment.
o In-vivo ADME – Validate unique scientific methods, assays, techniques, reports, etc. May assist in-life phase of study.
o 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
o Pharmacokinetics – Develop, validate and run sensitive, reliable and efficient LC/MS/MS assays for TK/PK assessment
o Simultaneously handle method development and validation, as well as routine projects.
o Coordinate study activities to ensure quality and efficiency.
o Perform high-volume sample analysis and/or data analysis, data QC, data summaries, and data interpretation.
o Evaluate significance of data and report findings.
o Prepare Study summaries and/or reports.
o Maintain schedule of projects and timelines, including databases and Master Schedule
o Communicate project timelines, status, data, reports, and inquiries to internal departments and/or external client/collaborators, effectively addressing any issues that may arise.
o Lead team in method development and validation.
o Collaborate with internal departments and/or external clients/etc. to maintain timely analysis and results, assessment, and technology transfer.
o Manage multiple projects at the same time.
o Set-up, utilize, and maintain routine and complex lab instrumentation
o Maintain the proper level of regulatory compliance for each study, preparing QA-related documents and addressing QA-related findings.
o Ensure that regulations and SOPs are followed in all activities.
o Maintain tools, computer programs, and SOPs required for studies.
o Research literature and external sources, and identify new techniques and procedures that strengthen QPS’ capabilities.
o Update database(s), or provide information as case may be, on a daily basis
o Supervise, train and/or mentor junior scientists.
o May prepare formulations for studies.
o May qualify or validate unique scientific methods, assays, techniques, etc.
o May prepare materials for presentations and publications.
o Follow safety precautions.
Competencies (“soft skills”, traits, behaviors – i.e., adaptability, analytical thinking, tenacity, initiative, results orientation)
o Creative thinking
o Conceptual thinking
o Results orientation
o Concern for standards
o Self-development orientation
Knowledge / Skills / Abilities (i.e., knowledge of GLP regulations, operation of lab equipment, mathematical ability)
o Understanding of experimental design and planning associated with assigned area, as well as data collection and analysis software.
o Demonstrated supervisory and managerial ability.
o Demonstrated knowledge of GLP regulations.
o Demonstrated skills associated with assigned area:
o Bioanalytical – experience operating LC-MS/MS, LC-UV/FLU/ECD, GC-MS, GC-FID/NPD/ECD instrumentation
o In vivo ADME – animal cannulation, dose administration, bleeding ability and experience working with radiolabel studies a plus
o Biotransformation – thorough understanding of MS/MS experiments
o Pharmacokinetics – understanding of preclinical pharmacokinetics
o Proven ability to successfully work in a team environment.
o Excellent oral and written communication skills.
o Ability to make independent decisions.
o Familiarity with LIMS and databases.
Education / Experience (minimum degree level and/or minimum number of years experience – including field of study and/or experience)
o Doctorate level degree in Analytical Chemistry, Biochemistry, Pharmacology or related science, OR
o Masters level degree in same disciplines with six (6) or more years of relevant experience, OR
o Bachelors level degree in same disciplines with a minimum of nine (9) or more years of relevant experience.