Senior Scientist, Bioanalytical Sciences

Senior Scientist, Bioanalytical Sciences Department: Bioanalytical Sciences / Nonclinical Development Work Location: Corporate Headquarters (South San Francisco) Position Summary: 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). Responsibilities: Bioanalytical Strategy 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. Scientific & Technical Leadership 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. Study Team Representation 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. Vendor & CRO Governance 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). Qualifications: Required 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. Preferred 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 Company Overview TCG Labs-Soleil, established in partnership with The Column Group, a science-focused venture capital firm, is pioneering a novel 'venture capital-biotech' model. Our core mission is to efficiently translate scientific insights into therapeutic solutions for patients facing serious diseases. This model supports scientific entrepreneurs from the initial idea to clinical proof of concept (PoC) by combining a dedicated fund (TCG Labs) with our independent, evergreen R&D center led by a top-tier scientific team (Soleil). Together, we create an integrated ecosystem that fosters the development of single-asset portfolio companies, strategically poised for transacting after clinical PoC. For more details, visit TCGLSoleil.com and follow us on LinkedIn EEO Statement TCG Labs-Soleil is an Equal Opportunity Employer. We do not discriminate against qualified applicants based upon any protected group status, including but not limited to race, religion, color, creed, sex (including breastfeeding and related conditions), gender identity/gender expression, pregnancy (including childbirth and related conditions), national origin, ancestry, age, marital status, military or veteran status, sexual orientation, genetic information, physical or mental disability or medical condition as defined by applicable equal opportunity laws. Any request for accommodation can be directed to View email address on click.appcast.io. Benefits and Compensation TCG Labs-Soleil provides a competitive benefits package that includes access to Medical, Dental, and Vision Insurance, Life Insurance, Short and Long Term Disability, Health Savings Account (HSA), Flexible Spending Accounts (FSA), 401k plan and PTO. The anticipated salary range for fully qualified candidates applying for this role will be $134,800 - $240,800 annually (not including discretionary bonus, equity, and benefits). The final salary offered will be dependent on several factors that include but are not limited to relevant previous experience including duration and type of experience within the industry, education, and internal equity, as well as alignment with market data, including potential adjustments for geographic location. #J-18808-Ljbffr Socket.dev