Principal Scientist, Analytical Ops
Gilead Sciences
8 days ago
On-site
Oceanside, CA
Operations
Principal Scientist in Biologics Analytical Development (Pivotal and Commercial)
Key Responsibilities:
- Provide scientific and people leadership to a team focused on extended characterization analysis (e.g., PTM characterization, intact and subunit mass analysis).
- Mentor, coach, and develop junior scientists; set expectations, performance goals, and scientific standards.
- Lead and oversee MS-based structural characterization strategies (intact mass, subunit analysis, peptide mapping, PTM profiling such as oxidation, deamidation, clipping, disulfide integrity, glycation, terminal variants).
- Define and drive late-stage characterization and control strategies aligned with CQAs and product quality targets.
- Serve as an Analytical Project Lead (ASTL) or senior analytical representative for late-phase programs to deliver high-quality characterization data.
- Author/review CMC sections for IND, BLA, and post-approval submissions; support interactions with global health authorities.
- Partner cross-functionally with Process Development, Quality, Manufacturing, CMC Regulatory Affairs, Technical Development, and Supply Chain.
- Drive adoption of advanced MS technologies/workflows (high-resolution MS, native MS, MAM, data-driven characterization).
- Ensure compliance with GMP, data integrity, and CMC regulatory expectations.
Qualifications:
- Ph.D. with 8+ years or M.S. with 10+ years industry experience in Analytical Chemistry/Biochemistry (or related), with significant biologics structural characterization experience.
- Deep expertise in MS (intact mass analysis, peptide mapping, PTM characterization).
- 3+ years leading/managing MS teams (mentoring, hiring, performance development).
- Strong CMC knowledge (CQAs, comparability, specifications, control strategies for late-stage biologics).
- Familiarity with techniques including high-resolution LC-MS, intact/subunit analysis, peptide mapping, MAM, SEC-MS, IEX-MS, RP-LC, native MS, and complementary biophysical methods.
- Knowledge of FDA, EMA, and ICH guidelines.
- Strong collaboration, communication, and stakeholder management; business acumen to balance resources and milestones.
On-site at Oceanside, CA; future transfer to Foster City, CA.
Salary range: $177,905.00–$230,230.00; may include discretionary bonus, stock incentives, paid time off, and a benefits package (medical, dental, vision, life insurance).
Application: For current Gilead employees/contractors, apply via the Internal Career Opportunities portal in Workday.
Key Responsibilities:
- Provide scientific and people leadership to a team focused on extended characterization analysis (e.g., PTM characterization, intact and subunit mass analysis).
- Mentor, coach, and develop junior scientists; set expectations, performance goals, and scientific standards.
- Lead and oversee MS-based structural characterization strategies (intact mass, subunit analysis, peptide mapping, PTM profiling such as oxidation, deamidation, clipping, disulfide integrity, glycation, terminal variants).
- Define and drive late-stage characterization and control strategies aligned with CQAs and product quality targets.
- Serve as an Analytical Project Lead (ASTL) or senior analytical representative for late-phase programs to deliver high-quality characterization data.
- Author/review CMC sections for IND, BLA, and post-approval submissions; support interactions with global health authorities.
- Partner cross-functionally with Process Development, Quality, Manufacturing, CMC Regulatory Affairs, Technical Development, and Supply Chain.
- Drive adoption of advanced MS technologies/workflows (high-resolution MS, native MS, MAM, data-driven characterization).
- Ensure compliance with GMP, data integrity, and CMC regulatory expectations.
Qualifications:
- Ph.D. with 8+ years or M.S. with 10+ years industry experience in Analytical Chemistry/Biochemistry (or related), with significant biologics structural characterization experience.
- Deep expertise in MS (intact mass analysis, peptide mapping, PTM characterization).
- 3+ years leading/managing MS teams (mentoring, hiring, performance development).
- Strong CMC knowledge (CQAs, comparability, specifications, control strategies for late-stage biologics).
- Familiarity with techniques including high-resolution LC-MS, intact/subunit analysis, peptide mapping, MAM, SEC-MS, IEX-MS, RP-LC, native MS, and complementary biophysical methods.
- Knowledge of FDA, EMA, and ICH guidelines.
- Strong collaboration, communication, and stakeholder management; business acumen to balance resources and milestones.
On-site at Oceanside, CA; future transfer to Foster City, CA.
Salary range: $177,905.00–$230,230.00; may include discretionary bonus, stock incentives, paid time off, and a benefits package (medical, dental, vision, life insurance).
Application: For current Gilead employees/contractors, apply via the Internal Career Opportunities portal in Workday.