About The Position

We are seeking a highly motivated Scientist or Senior Scientist to join the Bioanalysis group with a strong preclinical focus, supporting early-stage biologics drug development programs. The primary responsibility of this role is ligand binding assay (LBA) development and bioanalysis for preclinical pharmacokinetic (PK) studies in rodents and non-human primates, primarily under non-regulated conditions. The position may also support regulated GLP toxicology studies and involve interaction with external CRO partners for method transfer and study execution. Experience with ADA assay development is desirable and would be considered an add-on to the primary PK-focused responsibilities.

Requirements

  • Scientist BS/BA degree with 2+ years of industry experience in bioanalysis OR MS/MA degree and some experience as noted above OR PhD or equivalent and some experience as noted above
  • Hands-on experience with ligand binding assay development for PK bioanalysis
  • Experience supporting preclinical non-regulated studies, preferably in rodents and/or non-human primates
  • Basic understanding of GLP principles and bioanalytical best practices
  • Strong experimental, data analysis, and documentation skills
  • Senior Scientist BS/BA degree with 5+ years of industry experience in bioanalysis OR MS/MA degree and 3+ years of experience as noted above OR PhD or equivalent and some experience as noted above
  • Demonstrated expertise in preclinical PK LBA strategy and execution
  • Experience supporting GLP toxicology studies and working with quality/compliance functions
  • Proven experience interacting with and overseeing external CROs
  • Ability to work independently, lead bioanalytical efforts, and mentor junior scientists

Nice To Haves

  • Experience with ADA assay development is desirable and would be considered an add-on to the primary PK-focused responsibilities.
  • ADA assay development and support (screening/confirmatory/titer) may be involved on selected programs and is considered a desirable add-on to the primary PK role

Responsibilities

  • Develop, optimize, and qualify ligand binding assays (e.g., ELISA, MSD/ECL, Gyrolab) to support preclinical non-regulated PK studies of antibodies, bispecifics, and fusion proteins in rodents and monkeys
  • Perform hands-on bioanalysis of preclinical samples and ensure data quality, integrity, and scientific rigor
  • Author and review bioanalytical protocols, assay qualification/validation reports, and preclinical study reports
  • Analyze, interpret, and clearly communicate PK bioanalytical data to project and DMPK teams
  • Collaborate closely with DMPK, toxicology, and pharmacology groups to support study design and data interpretation
  • Interact with external CROs, including: Supporting assay and method transfer Providing technical oversight during outsourced studies Reviewing CRO data, reports, and study documentation
  • Troubleshoot assay issues and continuously improve assay performance and workflows
  • ADA assay development and support (screening/confirmatory/titer) may be involved on selected programs and is considered a desirable add-on to the primary PK role
  • At the Senior Scientist level: provide technical leadership, mentor junior scientists, and contribute to preclinical bioanalytical and outsourcing strategy

Benefits

  • In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program.
  • Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
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