Job Description
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.
In this lab-based, hands-on Scientist role, you will design, develop, and execute bioanalytical experiments that support the advancement of new therapies to market. You’ll spend much of your time in the lab generating and analyzing data, working with cutting-edge bioanalytical technologies, and evaluating assay performance within the intended context of use. This role is especially exciting due to our wide variety of clients and therapeutic areas, giving you exposure to multiple disease states and modalities. You’ll work in a milestone-driven, highly regulated environment where data integrity, quality, and compliance are foundational to how we operate.
We’re looking for scientists who are energized by hands-on laboratory work and solving complex scientific challenges. The ideal candidate is curious, driven to continuously learn, and experienced working under GxP expectations where data integrity is expected and upheld. You’ll thrive through collaboration with a network of expert scientists while managing multiple projects, sponsors, and timelines. If you’re adaptable, scientifically rigorous, and motivated by producing high-quality data at the bench, you’ll feel right at home at BioAgilytix.
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
Minimum Preferred Qualifications: Skills
- Experience with execution of PK/ADME, chromatographic, and other small molecule assays, and/or ability to perform most tasks associated with custom research planning and bench work
- Ability to develop chromatographic assays in some or all the following platforms: LC/MS/MS, UPLC and UPLC/HRMS
- 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)
Minimum Preferred Qualifications: Skills
- Ability to carry out routine tasks accurately, following strict methodology to carry out analysis, preparing samples and maintaining and operating standard laboratory equipment
- 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
- PK and PD (biomarker) 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 - Scientist II
- Bachelor’s degree in chemistry, biochemistry, biotechnology, biology, immunology, or related field with not less than eight (8) years’ experience in a scientific laboratory environment; or
- Master’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
- PhD in chemistry, biochemistry, biotechnology, biology, immunology, or related field with not less than four (4) years’ experience in a scientific laboratory environment
- A thorough knowledge of regulatory guidance and industry best practices for PK, ADME, LC/MC/MC, and other small molecule assays
Minimum Preferred Qualifications: Education/Experience - Scientist III
- 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
- A thorough knowledge of regulatory guidance and industry best practices for PK, ADME, LC/MC/MC, and other small molecule assays
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 PERKSMedical 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 OPPORTUNITYBioAgilytix 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.
