Job Information
Northeastern Bioanalytical Laboratories LLC Senior Scientist-Bioanalysis in Hamden, Connecticut
[Northeast Bioanalytical Laboratories LLC is an advanced bioanalytical lab services provider and clinical research organization (CRO) offering custom solutions to support the pharma, biopharma, and biotech industries in their drug discovery, translational science, and research and development operations. They are looking for a Senior Scientist-Bioanalysis to work full-time at their office at 35 Worth Avenue, Hamden, CT 06518 (M-F, 9 am-5 pm, 40-hour per week). [[What they are looking for: [[A skilled Senior Scientist-Bioanalysis who will have responsibilities in small molecule bioanalysis and related problem solving, and strategic initiatives to meet the client business needs. [[What you will be doing: [[Independently develop and validate bio-analytical methods for quantitative determination of test items in biological matrices and formulations using liquid chromatography-mass spectrometry (LC-MS)/MS and high performance liquid chromatography (HPLC) with various sample preparation techniques according to the FDA good laboratory practices (GLP) regulations and guidance. [[Complete stability testing in support of study sample analysis. Analyze clinical and non-clinical samples according to the standard operating practices (SOP) and regulatory requirements using chromatographic assays including LC-MS/MS and HPLC. [[Maintain laboratory, equipment, materials, chemicals, consumables, samples, solvents, and solutions to ensure cleanliness, adequate inventory and organization, clear labeling, current calibrations, personal safety, and that nothing for use has expired or compromised. [[Complete laboratory notebooks and other study records as per the Good Documentation Practices. Prepare and respond to change control, CAPA, and deviation reports, and respond to audit observations. [[Author and peer review computerized system validation, bio-analytical methods, SOPs, and study plans and reports. [[Train and mentor team members on laboratory procedures, instrumentation, software, and equipment [[What you will need: [[Master's or doctorate degree from an accredited institution in Pharmacy or a related field, such as Biochemistry, Chemistry, Industrial Chemistry, or Pharmaceutical Sciences, and minimum 12 months (with Doctorate degree) or 36 months (with Master's degree) of related full-time work experience, and special skills: Phramacokinetic (PK), toxicokinetic (TK), biomarker, bioavailability (BA), bioequivalence (BE), drug metabolism and pharmacokinetic (DMPK), absorption, distribution, metabolism, and elimination (ADME) and other bioanalytical studies; Method development and method validation as per the FDA guidelines; Proficiency with Watson LIMS software, SCIEX and HPLC instruments, and related software and tools ]{times="" new="" roman","serif""=""}]{sans-serif""=""}]{times="" new="" roman","serif""=""}]{sans-serif""=""}]{times="" new="" roman","serif""=""}]{sans-serif""=""}]{times="" new="" roman","serif""=""}]{sans-serif""=""}]{times="" new="" roman","serif""=""}]{sans-serif""=""}]{times="" new="" roman","serif""=""}]{sans-serif""=""}]{times="" new="" roman","serif""=""}]{sans-serif""=""}]{times="" new="" roman","serif""=""}]{sans-serif""=""}]{times="" new="" roman","serif""=""}]{sans-serif""=""}]{times="" new="" roman","serif""=""}]{sans-serif""=""}]{times="" new="" roman","serif""=""}]{sans-serif""=""}]{times="" new="" roman","serif""=""}