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Senior Scientist Project Lead

Company: Tergus Pharma
Location: Raleigh
Posted on: September 12, 2020

Job Description:

Summary of Key Responsibilities:----Developing and validating bioanalytical methods using HPLC and LC-MS/MS, and using the methods for sample analysis for the quantification of small molecules, peptides, and biomarkers in complex matrices--Support the analytical development efforts of multiple projects and perform a review of assay results/interpretation/reports to ensure technical excellence and compliance with appropriate regulatory standards--Perform routine maintenance for HPLCs and mass spectrometers, as well as the implementation of strategies to minimize instrument downtime, increase efficiency and productivity.--Analyze and evaluate HPLC and/or LC-MS/MS data to determine cutaneous drug delivery of actives from semi-solid formulations--Extensive experience working and extracting API from different biological matrices--Handling laboratory samples, troubleshooting and maintaining laboratory equipment, analyzing data using applicable software (Analyst and/or Empower 3), generating reports and summaries for presentations, managing data spreadsheets, requesting supplies and material as needed to perform general laboratory maintenance.--Write experimental protocols, summary reports, SOPs--Write and review analytical methods, protocols, and reports--Maintain a GLP/GMP-compliant analytical laboratory, and a safe working environment--Manage multiple projects simultaneously, and communicating with study sponsors and business partners--Mentor colleagues and junior scientists--Required Qualifications and Skills:----BS. / M.S. / Ph.D. in Chemistry, Biology, Biochemistry, Medical Sciences, Pharmaceutical Sciences, or other relevant sciences with at least 5-7+ years' bioanalytical industry experience.--2-5+ years' experience in GLP/GMP analytical laboratory setting required (experience in a pharmaceutical manufacturing setting preferred).--Expertise developing, transferring and validating various analytical methods--Working knowledge of regulatory requirements including cGMP, FDA, CFRs, ICH and USP expected--CRO experience preferred--Good understanding of skin biology and topical/cutaneous drug delivery preferred--Previous experience in topical product development/GMP laboratory setting preferred--Is thorough when performing work, conscientious in attending to detail--Excellent written and verbal communication skills--Uses logical thinking that is well organized and methodical--Responds to changing needs of the business, personally-identifying and championing new ideas for improvement and growth--Able to multi-task productively, is well-organized, applying time management processes and procedures effectively--Able to confer with others to reach a resolution, explore alternatives and positions to reach outcomes that gain the support of all parties--The qualified individual will be expected to work with minimal supervision in a cross-functional team environment in support of discovery and development projects. Knowledge of in vitro ADME assays, basic PK analysis, lab automation, metabolite/impurity identification is considered a plus.

Keywords: Tergus Pharma, Raleigh , Senior Scientist Project Lead, Other , Raleigh, North Carolina

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