Department / Function: CMC/Analytical
Work Location: This is an on-site position based at our corporate Headquarters (South San Francisco)
Position Summary:
TCG Labs-Soleil is looking for an experience analytical lead to join our CMC team. We are seeking a highly skilled and self-motivated professional to lead analytical development and quality control activities for our expanding portfolio of development programs. In this exciting role, you'll be working closely with internal teams and CDMOs to develop fast and efficient plans for analytical development and method qualification for biologics programs. As the primary point of contact, you will be responsible for providing general analytical oversight at CDMOs to support the on-time delivery of clinical materials.
Responsibilities:
Analytical Development
• Lead the development, optimization, qualification, and transfer of analytical methods for drug substances and drug products at CDMOs and external partners.
• Design and oversee analytical strategies to support process development, comparability studies, and stability programs.
• Ensure analytical methods are scientifically sound, phase-appropriate, and compliant with ICH, FDA, EMA, and other applicable regulatory guidelines.
• Manage stability trending activities using statistical and scientific evaluation.
• Manage troubleshooting and root cause investigations related to analytical methods and laboratory results.
Quality Control
• Manage method qualification activities at CDMOs.
• Review and approve analytical data, laboratory investigations, deviations, OOS/OOT results, CAPAs, protocols, and reports.
• Contribute to regulatory submissions including INDs, IMPDs, and related documentation by serving as a QC reviewer.
• Coordinate analytical activities with external laboratories, CDMOs, and testing partners.
• Provide technical expertise and risk assessments to support change controls and manufacturing investigations.
Qualifications:
• Bachelor's, Master's, or Ph.D. in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related scientific discipline.
• A minimum of 8(with BS) / 6(with MS) / 4(with PhD) years of experience in analytical development, quality control, or pharmaceutical/biotech laboratory operations.
• Strong expertise in analytical techniques such as HPLC, UPLC, CE, UV/Vis, bioassays, and mass spectrometry.
• Extensive experience with analytical method development, qualification, validation, and transfer following ICH guidelines.
• Experience managing laboratory investigations including deviations, OOS (Out-of-Specification), OOT (Out-of-Trend), CAPA, and root cause analysis.
• Experience with stability studies, specification setting, and product lifecycle management.
• Strong understanding of data integrity principles and laboratory documentation practices.
• Demonstrated ability to manage multiple projects, timelines, and cross-functional collaborations.
• Ability to travel to domestic and international sites as required.
• Experience overseeing external CROs, CMOs, or contract testing laboratories preferred.
• Experience in biologics and sterile products preferred.
• Experience in developing project and CMC timelines preferred.
• Ability to work independently and effectively in a dynamic, fast-paced, collaborative environment as a member of a cross-functional team.
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 $145,000-$190,000 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.
Staffing Agencies
TCG Labs-Soleil does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn't have a signed agreement with TCG Labs-Soleil. Please do not send agency CVs/resumes through TCG Labs-Soleil website or TCG Labs-Soleil Employees. Inquiries must be sent to [redacted] with the Subject Heading: Staffing Agency Request.
