Scientist I/II-Large Molecule (LC/MS)
Durham, NC
Lab Operations /
FT /
On-site
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.
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
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.
