Senior Scientist, Analytical CMC

Location: Millbrae, California, United States

Salary: $154,000–$185,850 per year, plus bonus and equity compensation

Company

hirify.global Therapeutics is a biopharmaceutical company developing treatments for life-threatening diseases through technologies combining chemistry, engineering, computation, and biology.

What you will do

• Lead analytical CMC activities for drug substance and drug product programs across clinical development, registration, and commercial readiness.
• Coordinate analytical deliverables, milestones, risks, and cross-functional collaboration across CMC, Quality, Regulatory, Manufacturing, Supply Chain, and Clinical Operations.
• Support method development, troubleshooting, qualification, transfer, validation, non-GMP analysis, investigations, release testing, and stability testing.
• Provide scientific oversight of CRO, CDMO, and external laboratory activities, including methods, protocols, reports, deviations, investigations, data summaries, and timelines.
• Develop analytical control strategies covering specifications, reference standards, impurity control, stability, shelf life, and analytical method readiness.
• Author and review technical documents and regulatory submission content, while providing technical guidance to junior staff and external collaborators.

Requirements

• Degree in analytical chemistry, chemistry, pharmaceutical sciences, or a related discipline, with substantial directly relevant analytical development or CMC experience.
• Experience supporting drug substance and/or drug product analytical development from clinical stages through registration.
• Knowledge of HPLC/UPLC, dissolution, GC, LC-MS, Karl Fischer, spectroscopy, solid-state, and compendial methods.
• Hands-on experience with analytical method development, troubleshooting, qualification, transfer, and/or validation in pharmaceutical or regulated laboratory settings.
• Understanding of phase-appropriate CMC, GMP and non-GMP requirements, impurities, stability, shelf life, specifications, and regulatory expectations.
• Strong communication, collaboration, organization, prioritization, and scientific problem-solving skills.

Nice to have

• Experience representing analytical development on cross-functional CMC teams from IND-enabling studies through later-stage development.
• Experience with analytical control strategies, specifications, stability trending, shelf-life assessments, and regulatory submission content.
• Experience overseeing CRO, CDMO, or external laboratory activities.

Culture & Benefits

• 401(k) plan with company matching.
• Medical, dental, and vision insurance with substantial premium coverage.
• Mental health and wellness benefits, enhanced parental leave, and life/AD&D insurance.
• Generous paid time off and holiday policies, including weeklong summer and winter shutdowns.
• Daily subsidized lunch program when working on site.