BioAgilytix
Scientist III -Large Molecule (LC/MS)
BioAgilytix, Durham, North Carolina, United States, 27703
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‑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.
Our Liquid Chromatography/Mass Spectrometry (LC/MS) team is seeking a Scientist III to serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical studies—including project scope definition, proposal preparation, timelines, scheduling, budget, and revenue management. This role is best suited for someone with deep expertise in method development, GxP‑compliant validation, and both targeted and untargeted analysis using chromatography and mass spectrometry, combined with strong communication skills and the confidence to engage with external clients.
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:
Serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical studies including project scope definition, proposal preparation, timelines, scheduling, budget, and revenue management.
Act as primary client contact, presenting data, ensuring clear communication, and aligning project deliverables with client timelines and expectations.
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.
Train, mentor, and direct junior scientists and analysts, including preparing and reviewing scientific training materials.
Provide scientific leadership by planning experimental designs for junior staff and driving bioanalytical projects to successful completion.
Additional Responsibilities:
Other duties as needed
Minimum Preferred Qualifications - Education/Experience (Scientist III):
Bachelor’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than 12 years’ experience in a scientific laboratory environment; or
Master’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than ten (10) years’ experience in a scientific laboratory environment; or
PhD in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than eight (8) years’ experience in a scientific laboratory environment
Knowledge of regulatory guidance and industry best practices for LC/MS, and other large molecule assays
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
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
The ability to inspire others to do their best work and drive results
Excellent customer service skills (internal and external)
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
BENEFITS AND OTHER PERKS Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (9 scheduled; 5 floating), 401k with Employer Match, Employee Referral Program
COMMITMENT TO EQUAL OPPORTUNITY BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.
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Our Liquid Chromatography/Mass Spectrometry (LC/MS) team is seeking a Scientist III to serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical studies—including project scope definition, proposal preparation, timelines, scheduling, budget, and revenue management. This role is best suited for someone with deep expertise in method development, GxP‑compliant validation, and both targeted and untargeted analysis using chromatography and mass spectrometry, combined with strong communication skills and the confidence to engage with external clients.
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:
Serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical studies including project scope definition, proposal preparation, timelines, scheduling, budget, and revenue management.
Act as primary client contact, presenting data, ensuring clear communication, and aligning project deliverables with client timelines and expectations.
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.
Train, mentor, and direct junior scientists and analysts, including preparing and reviewing scientific training materials.
Provide scientific leadership by planning experimental designs for junior staff and driving bioanalytical projects to successful completion.
Additional Responsibilities:
Other duties as needed
Minimum Preferred Qualifications - Education/Experience (Scientist III):
Bachelor’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than 12 years’ experience in a scientific laboratory environment; or
Master’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than ten (10) years’ experience in a scientific laboratory environment; or
PhD in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than eight (8) years’ experience in a scientific laboratory environment
Knowledge of regulatory guidance and industry best practices for LC/MS, and other large molecule assays
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
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
The ability to inspire others to do their best work and drive results
Excellent customer service skills (internal and external)
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
BENEFITS AND OTHER PERKS Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (9 scheduled; 5 floating), 401k with Employer Match, Employee Referral Program
COMMITMENT TO EQUAL OPPORTUNITY BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.
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