Scientist I/II-Large Molecule (LC/MS) en Bioagilytix

We are seeking a Scientist I/II to join our LC/MS large molecule team, supporting bioanalytical studies for biologics, proteins, peptides, ADCs, and biomarkers. In this role, you will take ownership of assay development, validation, and sample analysis using advanced chromatographic and mass spectrometric techniques. You’ll design and execute experiments, troubleshoot assays, analyze data, and prepare study documentation in alignment with GLP requirements. This is an excellent opportunity for a scientist with hands-on LC/MS experience who is looking to deepen their expertise in regulated bioanalysis and contribute directly to preclinical, clinical, and product release studies.At our organization, we're dedicated to pushing the boundaries of analytical science. Our LC/MS team leverages the synergy between liquid chromatography (LC) and mass spectrometry (MS) to revolutionize how we understand and quantify compounds in complex samples. With a steadfast commitment to excellence and innovation, we tackle challenges across the spectrum of drug discovery to clinical diagnostics, driving advancements that shape the future of healthcare.

Essential Responsibilities:

Independently 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.

Design, plan, and execute experiments independently; troubleshoot assays; analyze and interpret data; prepare summary tables, plans, reports, and SOPs.

Ensure GLP compliance throughout assay development, validation, and sample analysis activities, including prompt identification and notification of deviations and preparation of associated documentation.

Set up and manage studies in LIMS; maintain accurate laboratory records, worksheets, and raw data with peer review.

Prepare summary tables

Peer review raw data

Troubleshoot assays

Additional Responsibilities:

Other duties as needed

Minimum Preferred Qualifications - Education/Experience (Scientist I):

Bachelor’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than six (6) years’ experience in a scientific laboratory environment; or

Master’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than four (4) years’ experience in a scientific laboratory environment; or

PhD in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than two (2) years’ experience in a scientific laboratory environment

Knowledge of regulatory guidance and industry best practices for LC/MS, and other large molecule assays

Hands on experience with developing chromatographic and mass spectrometric assays including LC/MS and LC/MS/MS for bioanalytical studies

Experience in data analysis, data visualization statistical analysis

Microsoft Word, Excel, Sciex OS/Analyst, MassLynx, XCalibur, Chromeleon, Watson LIMS, JMP, Graphpad Prism

GDP, GLP, GCLP, GCP

Minimum Preferred Qualifications - Education/Experience (Scientist II):

Bachelor’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than eight (8) years’ experience in a scientific laboratory environment; or

Master’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than six (6) years’ experience in a scientific laboratory environment; or

PhD in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than four (4) years’ experience in a scientific laboratory environment

Knowledge of regulatory guidance and industry best practices for LC/MS, and other large molecule assays

Hands on experience with developing chromatographic and mass spectrometric assays including LC/MS and LC/MS/MS for bioanalytical studies

Experience in data analysis, data visualization statistical analysis

Microsoft Word, Excel, Sciex OS/Analyst, MassLynx, XCalibur, Chromeleon, Watson LIMS, JMP, Graphpad Prism

GDP, GLP, GCLP, GCP

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

A knack for designing efficient and impactful experiments

Experience working in a regulated environment, with a thorough understating of GDP, GLP, GCLP, GCP

Independence, enthusiasm, openness, and adaptability

Demonstrated effective communication skills

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 eight (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

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