Senior Scientist, Bioanalytical Sciences

Senior Scientist, Bioanalytical Sciences

Department: Bioanalytical Sciences / Nonclinical Development

TCG Labs-Soleil is looking for a top-notch Senior Scientist, Bioanalytical Sciences to join our team. We are seeking a Senior Scientist to serve as the scientific and strategic lead for Bioanalytical Sciences on assigned discovery, nonclinical, and clinical programs. This role represents Bioanalytical Sciences on cross-functional study teams, formulates the bioanalytical strategy for pharmacokinetic (PK), anti-drug antibody (ADA), and biomarker assays across a program's lifecycle, and provides scientific and technical leadership to Scientists and Senior Research Associates.

The role is expected to stay current with newer bioanalytical technologies — such as hybrid immunocapture-LC-MS/MS methods, ultra-sensitive platforms, to recommend the appropriate platform for each program. The role also provides hands-on technical support to troubleshoot complex assays and evaluate data quality. Oversight/Lab Split:
Approx. 80% technical & vendor oversight; study-team representation, 20% hands on lab work (troubleshooting complex assay/ exploring newer technologies).

• Formulate and own the end-to-end bioanalytical strategy for assigned programs — assay platform selection, validation approach, and sequencing of PK, ADA, and biomarker testing from discovery through IND-enabling and clinical stages.
• Anticipate scientific and operational risks to the bioanalytical plan (matrix effects, ADA impact on PK, assay sensitivity) and build mitigation into the strategy.

• Provide scientific oversight for the design, development, optimization, and qualification/validation of ligand binding assays (LBA) for PK, ADA, and biomarker applications.
• Evaluate and recommend emerging bioanalytical technologies (e.g., Simoa, Gyrolab, immunocapture-LC-MS/MS hybrid methods, multiplexed biomarker platforms) for fit-for-purpose use across programs.
• Serve as the escalation point for complex assay troubleshooting and data interpretation issues arising from internal and external bioanalytical activities.
• Review and approve assay data, reports, and method documentation for scientific soundness prior to team or regulatory review.
• Mentor and provide technical guidance to Scientists and Senior Research Associates.
• Monitor the bioanalytical technology landscape and drive adoption of new platforms and instrumentation that improve sensitivity, throughput, or specificity.

• Serve as the primary Bioanalytical Sciences representative on cross-functional program and study teams (Discovery, Nonclinical Development, Translational Sciences, Clinical Development, Regulatory Affairs).
• Act as the accountable point of contact for bioanalytical questions, timelines, and risk in team meetings.
• Translate program-level objectives into bioanalytical deliverables, and translate bioanalytical constraints (assay feasibility, timelines, sample volume) back to the broader team.
• Negotiate bioanalytical timelines, sample budgets, and resourcing with Study Directors, Program Leads, and Clinical Operations.
• Own vendor selection and governance for external bioanalytical laboratories supporting assigned programs.
• Provide scientific oversight of method development, transfer, and validation activities performed by CROs; review and approve protocols and reports.
• Serve as the senior technical contact for escalated troubleshooting and scientific disputes with external partners.
• Participate in vendor qualification and study audits (occasional travel required).

• Ph.D. + 5 years, M.S. + 8 years, or B.S. + 10 years of relevant hands-on industry experience…