Scientist, Bioanalytical and Translational Sciences (PK, ADA, Biomarkers) jobs in United States
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TCG Labs Soleil ยท 1 day ago

Scientist, Bioanalytical and Translational Sciences (PK, ADA, Biomarkers)

TCG Labs-Soleil is seeking a highly motivated and detail-oriented Scientist to join their Bioanalytical/Translational Research team. This role focuses on the design, development, and execution of bioanalytical assays to support clinical and non-clinical programs, including pharmacokinetics, anti-drug antibody, and biomarker assessments.

Biotechnology

Responsibilities

Design, develop, optimize, and qualify ligand binding assays (LBA) for:
Pharmacokinetics (PK)
Immunogenicity (ADA)
Biomarker detection (exploratory and translational)
Perform non-clinical sample analysis to support discovery and development programs
Troubleshoot assay performance issues, implement improvements, and document method changes
Conduct critical reagent labeling (e.g., biotinylation, fluorophore conjugation) and manage reagent inventory
Maintain accurate and detailed records in electronic lab notebooks (ELNs) and ensure compliance with internal quality systems
Analyze and interpret data; present findings to project teams
Coordinate and oversee method development, transfer, and validation activities at external bioanalytical labs
Review protocols, reports, and data from CROs to ensure quality and compliance with regulatory expectations
Serve as a technical point of contact for troubleshooting and assay-related discussions with external partners
Work closely with Research, Nonclinical Development, Translational Sciences, and Clinical Development teams to align bioanalytical strategies with program goals

Qualification

Ligand binding assaysMSD platformsELISA platformsReagent labelingNon-clinical sample analysisTroubleshooting skillsDocumentationOrganizational skillsCross-functional collaboration

Required

Degree in Biochemistry, Molecular Biology, Pharmacology, or related field: BS + 8 years, MS + 5 years, or PhD + 2 years of relevant hands-on industry experience in bioanalytical or immunoassay settings
Strong experience in ligand binding assays for PK, ADA, and biomarker applications
Proficiency with MSD (electrochemiluminescence) and ELISA platforms
Demonstrated ability to troubleshoot and optimize assay performance
Experience with non-clinical sample matrices (e.g., rodent, NHP plasma or serum)
Expertise in reagent labeling and qualification (biotinylation, conjugation)
Excellent documentation and organizational skills

Preferred

Experience managing assays at external CROs is a plus
Experience with automated immunoassay platforms (e.g., Gyrolab) is a plus
Knowledge of regulatory bioanalytical guidelines (FDA, EMA)
Familiarity with GLP or GxP-adjacent environments

Benefits

Medical, Dental, and Vision Insurance
Life Insurance
Short and Long Term Disability
Health Savings Account (HSA)
Flexible Spending Accounts (FSA)
401k plan
PTO

Company

TCG Labs Soleil

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At TCG Labs Soleil, we are establishing a pioneering venture-biotech model in collaboration with The Column Group.

Funding

Current Stage
Early Stage

Leadership Team

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Jin-Long Chen
Managing Partner, TCG Labs | Co-Founder and Chief Executive Officer, Soleil
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Harding Luan
VP, Discovery Research and Co-Founder
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