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