Senior Scientist, Bioanalytical Sciences

Soleil Labs, LLC•South San Francisco, CA

3d•$134,800 - $240,800•Onsite

About The Position

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).

Requirements

Ph.D. + 5 years, M.S. + 8 years, or B.S. + 10 years of relevant hands-on industry experience in bioanalytical or immunoassay settings, in Biochemistry, Molecular Biology, Pharmacology, or a related field.
Demonstrated experience developing ligand binding assays for PK, ADA, and biomarker applications, including method qualification and/or validation.
Demonstrated ability to formulate and communicate a bioanalytical strategy that spans discovery through clinical development.
Proficiency with MSD (electrochemiluminescence) and ELISA platforms; experience with non-clinical and/or clinical sample matrices.
Demonstrated awareness of newer and emerging bioanalytical technologies (e.g., Simoa/single-molecule arrays, Gyrolab and other automated immunoassay platforms, high-resolution and hybrid LC-MS/MS approaches, multiplex biomarker panels) and their appropriate application.
Strong written and verbal communication skills, with experience presenting to program teams and governance forums.
Experience overseeing external CRO activities, including protocol and report review.

Nice To Haves

Proven track record representing a technical function on cross-functional program or study teams, including direct interaction with Clinical Development, Nonclinical Development, or Translational Sciences.
Working knowledge of GLP/GxP-regulated bioanalytical environments.
Prior experience mentoring or providing technical leadership to junior scientific staff.
Familiarity with FDA and EMA bioanalytical method validation guidance

Responsibilities

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).