Senior Analytical Lead, Biologics & QC

Soleil Labs, LLC; South San Francisco (CA); On-site; USD 145,000 - 190,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

HSA

FSA

401k

PTO

Job summary

TCG Labs-Soleil in South San Francisco, CA on-site, is seeking an experienced analytical lead to join our CMC team. You will lead analytical development and quality control activities for our expanding portfolio, working with internal teams and CDMOs to plan analytical development and method qualification for biologics programs.

As the primary contact, you will provide analytical oversight at CDMOs to support on-time delivery of clinical materials, manage stability and investigations, and guide

Qualifications

• Bachelor’s, Master’s, or Ph.D. in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related scientific discipline.
• Minimum years of experience: 8 (BS), 6 (MS), 4 (PhD) in analytical development, quality control, or pharmaceutical/biotech labs.
• 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, OOT, 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.

Responsibilities

• Lead the development, qualification, and transfer of analytical methods 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 guidelines.
• Manage stability trending activities using statistical and scientific evaluation.
• Manage troubleshooting and root cause investigations related to analytical methods and laboratory results.
• Manage method qualification activities at CDMOs.
• Review and approve analytical data, investigations, deviations, OOS/OOT, CAPAs, protocols, and reports.
• Contribute to regulatory submissions including INDs, IMPDs, and related documentation as 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.

Skills

Analytical method development

HPLC/UPLC/LC-MS

Quality control

Data integrity

Regulatory compliance

Cross-functional collaboration

Project management

Education

Bachelor’s/Master’s/PhD in a related science

Experience 8/6/4 years in analytical development/QC/pharma labs

Biologics/biotech lab experience

Job description

TCG Labs-Soleil in South San Francisco, CA on-site, is seeking an experienced analytical lead to join our CMC team. You will lead analytical development and quality control activities for our expanding portfolio, working with internal teams and CDMOs to plan analytical development and method qualification for biologics programs.

As the primary contact, you will provide analytical oversight at CDMOs to support on-time delivery of clinical materials, manage stability and investigations, and guide