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 staffDrive bioanalytical projects to align with client timelinesFrequent communication with clients to discuss technical details and provide project updates.Advise clients on PK/ADME assay best practicesAuthor documents (methods, SOPs, reports) Statistical analysis of bioanalytical dataReview of documentationPeer review raw dataPrepare reagentsTroubleshoot assaysDesign assay runs independentlyResponsible for prompt identification and notification of deviationsWrite plans/reports for sample analysisOrder and keep accurate inventories of supplies for laboratory needs and forecast future needs based on projected project needsPerform assays according to GLP guidance or SOPs
Additional Responsibilities
Other duties as needed
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 workAbility to develop chromatographic assays in some or all the following platforms: LC/MS/MS, UPLC and UPLC/HRMSA knack for designing efficient and impactful experimentsExperience working in a regulated environment, with a thorough understating of GDP, GLP, GCLP, GCP Independence, enthusiasm, openness, and adaptabilityDemonstrated effective communication skills The ability to inspire others to do their best work and drive resultsExcellent 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 equipmentMust work effectively within team to meet objectives under time constraintsAbility to take direction well and multi-taskDetail oriented and highly organizedDemonstrated expertise in chromatographic assay developmentAdvanced capabilities in data analysis, data visualization statistical analysis PK and PD (biomarker) assay development and validationMicrosoft 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 preferredExcellent 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; orMaster’s degree in chemistry, biochemistry, biotechnology, biology, immunology, or related field with not less than six (6) years’ experience in a scientific laboratory environment; orPhD in chemistry, biochemistry, biotechnology, biology, immunology, or related field with not less than four (4) years’ experience in a scientific laboratory environmentA 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; orMaster’s degree in chemistry, biochemistry, biotechnology, biology, immunology, or related field with not less than ten (10) years’ experience in a scientific laboratory environment; orPhD in chemistry, biochemistry, biotechnology, biology, immunology, or related field with not less than eight (8) years’ experience in a scientific laboratory environmentA 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 instructionsFrequently exercises discretionary authority
Working Environment
Primarily laboratory environmentExposure to biological fluids with potential exposure to infectious organismsRare exposure to skin and lung irritants, toxic materials, and hazardous wastePersonal protective equipment required, such as protective eyewear, garments, and glovesRoutinely 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 dayRepetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipmentFrequent mobility neededFrequent crouching, stooping, with frequent bending and twisting of upper body and neckLight to moderate lifting and carrying (or otherwise moves) objects including laboratory equipment, laboratory supplies, and laptop computer with a maximum lift of 20 poundsAbility 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 sentencesFrequently interacts with others to obtain or relate information to diverse groupsRequires multiple periods of intense concentrationPerforms a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrenceAbility to perform under stress and multi-taskRegular and consistent attendance
Position Type and Expected Hours of Work
This is a full-time positionSome flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee HandbookOccasional weekend, holiday, and evening work requiredOccasional 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
COMMITMENT TO EQUAL OPPORTUNITY
BioAgilytix 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.
