In this hands-on, laboratory-based Scientist role, you will design, develop, and execute bioanalytical methods and experiments supporting the advancement of new therapies, with a particular focus on large-molecule LC/MS applications. You'll spend much of your time at the bench performing method development, optimization, and GxP-compliant validation; generating and analyzing data; evaluating assay performance; and conducting targeted and untargeted analyses using liquid chromatography and mass spectrometry.
This role is a strong fit for someone who enjoys being in the lab, working through complex scientific problems, and seeing a method through from development to validation and execution. You'll work across a variety of client programs and therapeutic areas, which means the science and day-to-day challenges can vary quite a bit. We're looking for someone with strong LC/MS experience who is comfortable working in a regulated environment and understands the importance of producing accurate, high-quality data.
Essential Responsibilities- 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.
- 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 LC/MS 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 ResponsibilitiesMinimum 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
- Ability to take direction well and multi-task
- Detail oriented and highly organized
- Demonstrated expertise in chromatographic assay development
- Advanced capabilities in data analysis, data visualization statistical analysis
- LC/MS assay development and validation
- Microsoft word, Excel, Sciex OS/Analyst, MassLynx, Chromeleon, Watson LIMS, JMP, Graphpad Prism
- Ability to develop protein binding, CYP inhibition, CYP induction, or CYP phenotyping and/or ability to develop chromatographic assays using HPLC or LC/MS/MS.
- Experience working in a GxP environment preferred
- Excellent oral and written communication skills
Minimum Preferred Qualifications: Education/Experience- Bachelor's degree in chemistry, biochemistry, biotechnology, biology, immunology, or related field with not less than 12 years' experience in a scientific laboratory environment; or
- Master's degree in chemistry, biochemistry, biotechnology, biology, immunology, or related field with not less than ten (10) years' experience in a scientific laboratory environment; or
- PhD in chemistry, biochemistry, biotechnology, biology, immunology, or related field with not less than eight (8) years' experience in a scientific laboratory environment
- 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
Supervisory Responsibility- This position may supervise Analyst I/II/III
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
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
