QC Analytics Lead - Principal Scientist (Small Molecules)

Biopharma Careers; Foster City (CA); On-site; USD 196,000 - 253,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Job summary

Gilead Sciences seeks a Principal Scientist, Analytical Operations to lead QC strategy for small molecule clinical development. You will oversee method validation, release testing, and data integrity, partnering with regulators and cross-functional teams to enable delivery of clinical materials.

The role requires deep analytical chemistry expertise, cGMP operations leadership, and experience guiding external testing laboratories and regulatory submissions.

Qualifications

• BS/MS/PhD in a relevant field with extensive experience in analytical testing and QC.
• 10+ years with BS OR, 8+ years with MS OR, 5+ years with PhD or PharmD.
• Deep understanding of regulatory expectations for clinical development.
• Experience leading testing activities at external laboratories.
• Strong communication and cross-functional collaboration.

Responsibilities

• Define and lead QC strategy for small molecule clinical programs.
• Oversee method validation, transfer, reference materials, and release testing.
• Ensure phase-appropriate QC specs and data integrity for regulatory submissions.
• Coordinate with internal teams and contract labs to meet timelines.

Skills

Analytical chemistry

cGMP operations

Quality leadership

Regulatory submissions

Cross-functional collaboration

Documentation & data integrity

Contract testing oversight

Education

Bachelor's degree in a related field

Master's degree in a related field

PhD or PharmD in a related field

Tools

Regulatory knowledge (CMC)

Job description

Gilead Sciences seeks a Principal Scientist, Analytical Operations to lead QC strategy for small molecule clinical development. You will oversee method validation, release testing, and data integrity, partnering with regulators and cross-functional teams to enable delivery of clinical materials.

The role requires deep analytical chemistry expertise, cGMP operations leadership, and experience guiding external testing laboratories and regulatory submissions.