Scientist I - LC/MS (Bioanalytical)

Essential Responsibilities

• Lead the development, validation, and sample analysis of large molecules such as ADCs, monoclonal antibodies and other proteins, peptides, oligonucleotides, biomarkers, and small molecules using various techniques including chromatographic (LC-MS/MS) in support of preclinical and clinical PK/PD 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 PK/ADME 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

• Ability to perform routine laboratory tasks accurately while following established methodologies, including sample preparation, operation and maintenance of standard laboratory equipment.
• Experience with chromatographic assay development, validation, and execution for PK, PD (biomarker), ADME, and other small molecule assays.
• Experience developing chromatographic assays using LC-MS/MS, HPLC, UPLC, and/or UPLC-HRMS, including protein binding, CYP inhibition, CYP induction, or CYP phenotyping assays.
• Strong data analysis, statistical analysis, and data visualization skills.
• Proficiency with Microsoft Office (Word, Excel) and scientific software such as Sciex OS/Analyst, MassLynx, Chromeleon, Watson LIMS, JMP, and GraphPad Prism.
• Experience working in a regulated laboratory environment with knowledge of GxP principles, including GLP, GCLP, GCP, and Good Documentation Practices (GDP).
• Strong experimental design, troubleshooting, and scientific problem-solving skills.
• Ability to manage multiple priorities, work independently, and adapt to changing priorities while taking direction effectively.
• Highly organized, detail-oriented, and able to meet deadlines in a fast-paced environment.
• Strong verbal and written communication skills with the ability to collaborate effectively across cross-functional teams.
• Demonstrated customer service mindset with a commitment to delivering high-quality results for internal and external stakeholders.

Minimum Preferred Qualifications: Education/Experience - Scientist I

• Bachelor’s degree in chemistry, biochemistry, biotechnology, biology, immunology, or related field with not less than six (6) years’ experience in a scientific laboratory environment; or
• Master’s degree in chemistry, biochemistry, biotechnology, biology, immunology, or related field with not less than four (4) years’ experience in a scientific laboratory environment; or
• PhD in chemistry, biochemistry, biotechnology, biology, immunology, 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 PK, ADME, LC/MC/MC, and other small molecule assays is preferred

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