Scientist 3

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