Scientist II/III - LC/MS Bioanalytical

BioAgilytix • San Diego, CA

9d • Onsite

About The Position

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.

Requirements

• 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)
• 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
• Microsoft word, Excel, Sciex OS/Analyst, MassLynx, Chromeleon, Watson LIMS, JMP, Graphpad Prism
• A thorough knowledge of regulatory guidance and industry best practices for PK, ADME, LC/MC/MC, and other small molecule assays
• 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
• 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

Nice To Haves

• PK and PD (biomarker) assay development and validation
• 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

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
• Other duties as needed

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level