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Bioagilytix

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Scientist III - LC/MS (Bioanalytical)

DurhamOn-site

AI Summary

Designs, develops, and executes LC/MS bioanalytical methods and experiments for biologics, proteins, peptides, ADCs, and biomarkers in a regulated GxP laboratory environment.

About this role

At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.

In this hands-on, laboratory-based Scientist role, you will design, develop, and execute bioanalytical methods and experiments supporting the advancement of new therapies, with a particular focus on large-molecule LC/MS applications. You’ll spend much of your time at the bench performing method development, optimization, and GxP-compliant validation; generating and analyzing data; evaluating assay performance; and conducting targeted and untargeted analyses using liquid chromatography and mass spectrometry.

This role is a strong fit for someone who enjoys being in the lab, working through complex scientific problems, and seeing a method through from development to validation and execution. You’ll work across a variety of client programs and therapeutic areas, which means the science and day-to-day challenges can vary quite a bit. We’re looking for someone with strong LC/MS experience who is comfortable working in a regulated environment and understands the importance of producing accurate, high-quality data.

Essential Responsibilities

  • Lead assay development, validation, and sample analysis of biologics, proteins, peptides, ADCs, and/or biomarkers using chromatographic and mass spectrometric (LC/MS) techniques in support of preclinical, clinical, and product release studies.
  • Plan and direct experimental design for junior staff
  • Drive bioanalytical projects to align with client timelines
  • Frequent communication with clients to discuss technical details and provide project updates.
  • Advise clients on LC/MS assay best practices
  • Author documents (methods, SOPs, reports)
  • Statistical analysis of bioanalytical data
  • Review of documentation
  • Peer review raw data
  • Prepare reagents
  • Troubleshoot assays
  • Design assay runs independently
  • Responsible for prompt identification and notification of deviations
  • Write plans/reports for sample analysis
  • Order and keep accurate inventories of supplies for laboratory needs and forecast future needs based on projected project needs
  • Perform assays according to GLP guidance or SOPs

    • Additional Responsibilities

  • Other duties as needed

    • Minimum Preferred Qualifications: Skills

  • Experience with development, validation and execution of chromatographic and mass spectrometric assays (LC/MS), and/or ability to perform most tasks associated with custom research planning and bench work
  • Must work effectively within team to meet objectives under time constraints
  • Ability to take direction well and multi-task
  • Detail oriented and highly organized
  • Demonstrated expertise in chromatographic assay development
  • Advanced capabilities in data analysis, data visualization statistical analysis
  • LC/MS assay development and validation
  • Microsoft word, Excel, Sciex OS/Analyst, MassLynx, Chromeleon, Watson LIMS, JMP, Graphpad Prism
  • Ability to develop protein binding, CYP inhibition, CYP induction, or CYP phenotyping and/or ability to develop chromatographic assays using HPLC or LC/MS/MS.
  • Experience working in a GxP environment preferred
  • Excellent oral and written communication skills

    • Minimum Preferred Qualifications: Education/Experience

  • Bachelor’s degree in chemistry, biochemistry, biotechnology, biology, immunology, or related field with not less than 12 years’ experience in a scientific laboratory environment; or
  • Master’s degree in chemistry, biochemistry, biotechnology, biology, immunology, or related field with not less than ten (10) years’ experience in a scientific laboratory environment; or
  • PhD in chemistry, biochemistry, biotechnology, biology, immunology, or related field with not less than eight (8) years’ experience in a scientific laboratory environment
  • Demonstrated expertise in developing chromatographic and mass spectrometric assays including LC/MS and LC/MS/MS for bioanalytical studies by extracting analytes of interest from complex biological matrices using protein precipitation, liquid-liquid, solid phase, immunoprecipitation or other extraction technique
  • Advanced capabilities in data analysis, data visualization statistical analysis

    • Supervisory Responsibility

  • This position may supervise Analyst I/II/III

    • Supervision Received

  • Infrequent supervision and instructions
  • Frequently exercises discretionary authority

    • Working Environment

  • Primarily laboratory environment
  • Exposure to biological fluids with potential exposure to infectious organisms
  • Rare exposure to skin and lung irritants, toxic materials, and hazardous waste
  • Personal protective equipment required, such as protective eyewear, garments, and gloves
  • Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets

    • Physical Demands

  • Ability to work in an upright and/or stationary position for up to 8 hours per day
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment
  • Frequent mobility needed
  • Frequent crouching, stooping, with frequent bending and twisting of upper body and neck
  • Light to moderate lifting and carrying (or otherwise moves) objects including laboratory equipment, laboratory supplies, and laptop computer with a maximum lift of 20 pounds
  • Ability to access and use a variety of computer software
  • Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
  • Frequently interacts with others to obtain or relate information to diverse groups
  • Requires multiple periods of intense concentration
  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
  • Ability to perform under stress and multi-task
  • Regular and consistent attendance

    • Position Type and Expected Hours of Work

  • This is a full-time position
  • Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook
  • Occasional weekend, holiday, and evening work required
  • Occasional travel required

    • Skills

    ChromeleonExcelGLPGraphPad PrismGxPHPLCImmunoprecipitationJMPLC/MSLC/MS/MSLiquid-liquid ExtractionMassLynxMethod ValidationProtein PrecipitationSciex OS/AnalystSolid Phase ExtractionStatistical AnalysisWatson LIMS

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