Quality Assurance Associate

Biologist II – Ligand Binding Assay

We are seeking a highly motivated and dedicated Ligand Binding Assay Bioanalyst (Biologist II) to join the Quantitative Translational and ADME Sciences (QTAS) department. The LBA Operations Bioanalytical Team performs quantitative bioanalysis of large-molecule therapeutics, including mAbs, ADCs, AOCs, fusion proteins, and bispecifics, for Pharmacokinetic (PK), Pharmacodynamic (PD), and Toxicokinetic (TK) studies using ligand binding assays to support drug discovery and early development efforts. The primary responsibilities of the Ligand Binding Assay Bioanalyst (Biologist II) include:

1. Performing pre-clinical sample analysis in multiple biological matrices using hybrid manual and automated ligand binding assays (MSD) to generate high-quality bioanalytical data.
2. Supporting the LBA Method Development team as needed by designing, troubleshooting, and validating new LBA analysis assays for transfer to the LBA Ops team.
3. Meticulously preparing, reviewing, documenting, and reporting bioanalytical data packages to enable downstream PK/PD/TK analysis.
4. Supporting the overall function of the LBA Operations team through shared equipment maintenance and reagent/sample inventory management.

The ideal candidate will be a self-motivated, highly adaptable scientist with strong attention to detail, the ability to quickly learn new concepts, and a commitment to clear, consistent communication in a fast-paced, dynamic environment.

Top skills required:

• Previous experience with ligand binding workflows (ELISA, MSD) is required.
• Proven ability to independently troubleshoot, problem-solve, and adapt to dynamic priorities.
• 2+ years (MS) or 4+ years (BS) of pharmaceutical and/or biotechnology industry experience is preferred.
• Experience with lab automation is highly desirable.
• Previous experience independently developing ligand binding assays is preferable.

Responsibilities:

• Independently plan and execute sample analysis based on bioanalytical protocols and in vivo study designs using a variety of biological matrices, including tissue lysates, serum, and others.
• Run ligand binding assays (PK, PD, TK, ADA) using Meso Scale Discovery platforms.
• Analyze pre-clinical in vivo samples according to a dynamically changing operational schedule.
• Interpret, discuss, and present assay results; use results to guide and adjust analysis strategy.
• As needed, support the LBA MD team by independently developing fit-for-purpose ligand binding assays for transfer to the LBA Ops Team.
• Perform timely, accurate, and thorough data archiving in ELN and rLIMS.
• Communicate experimental plans and results effectively, both verbally and in writing, with broader teams and during regular lab meetings.
• Actively support day-to-day laboratory operations.

Required qualifications:

• Bachelor's or MS degree in Biology, Chemistry, or Pharmacology.
• 2+ years (MS) or 4+ years (BS) of pharmaceutical and/or biotechnology industry experience is preferred.
• Previous experience with ligand binding workflows (ELISA, MSD) is required.
• Previous experience independently developing ligand binding assays is preferable.
• Proven ability to independently troubleshoot, problem-solve, and adapt to dynamic priorities.
• Ability to operate and maintain laboratory equipment independently.
• Experience with lab automation is highly desirable.
• Excellent written and verbal communication skills, with the ability to draft technical reports.
• Proficiency with computers and data analysis software, including Excel and LIMS.
• Ability and willingness to work effectively in a highly collaborative and multidisciplinary environment.

Benefits: The company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually.