Associate Director​/Director, Analytical Characterizations

Associate Director / Director, Analytical Characterizations

Department:
Technology

Position Summary:

TCG Labs Soleil is seeking an expert and engaged Associate Director / Director, Analytical Characterization
to head our analytical and biophysical characterization efforts within the Protein Sciences group of the Biologics Technology team. In this pivotal role, you will provide strategic vision and oversight for develop ability assessments, analytical characterization, and method strategy acrossourbiologicsportfolio. While leading from the bench tostayclosely connected to the science, you and your team will generate critical data that guide key decision-making in candidateselectionand due diligence.

You will lead and mentor a high-performing scientific team, drive the adoption of novel analytical technologies, and contribute strategically to the direction and success ofourbiologicsportfolio. This is an on-site position based at our corporate headquarters in South San Francisco, CA.

Responsibilities:

• Prepare develop ability assessments packages for biologic candidates (proteins, antibodies, multi-specifics, etc.), evaluating stability, solubility, aggregation, post-translational modifications, manufacturability, and risk factors.
• Design, develop,validate, and execute analytical and biophysical methods (with emphasis on LC-MS, chromatography, spectroscopy, thermal/structural assays) to characterize therapeutic proteins and antibodies throughout the preclinical pipeline.
• Lead from the bench,utilizingtechnicalexpertiseto conduct experimental setups and troubleshoot complex issues.
• Serve as the analytical lead in due diligence and business development contexts: evaluate external data, review analytical packages,identify technical risk, and advise decision-makers.
• Manage CROs and external collaborations for method development, validation, tech transfer, and analytical support ensuring quality, timelines, and cost efficiency.
• Evaluate emerging analytical technologies for feasibility, cost-effectiveness, and performance; guide their adoption to enhance throughput, sensitivity, and risk mitigation.
• Mentor and manage a high-performing analytical team; set scientific and operational priorities, ensure training, help with professional development.
• Collaborate closely with CMC to align analytical strategies with formulation and process development.

Qualifications:

• Ph.D. or equivalent in a related discipline (e.g.biochemistry, biophysics, analytical chemistry) with8+ years' experience in monoclonal and multi-specific antibody characterization in industry setting, preferably startup or biotechnology companies.
• Proven leadership experience witha track recordof managing direct reports and mentoring scientific teams.
• Proficient in analytical methods that include but not limit to HPLC, CE, SPR, DSF, DSC, SEC-MALS, LC-MS.
• Strong understanding of protein analytical principles and methodologies.
• Extensive experience in characterizing biologics post-translational modifications (PTMs).
• In-depth knowledge of attributes of protein therapeutic drug candidates.
• Extensive hands-on experience in develop ability studies for antibody therapeutics, including monoclonal andmultispecificantibodies, fusion proteins, and antibody-drug conjugates.
• Deep understanding of biologics drug discovery process, particularly hit-to-lead, lead optimization, and candidate selection.
• Research-driven mindset with a focus on therapeutic development.
• Familiarity with CMC development process; prior experience with Investigational New Drug (IND) filing required.
• Meticulous in data organization; capable of multitasking and managing multiple projects without compromising quality.
• Excellent oral and written…