Senior Scientist, Analytical Sciences

The Senior Scientist in Analytical Sciences will play a crucial role in the development and characterization of new therapeutic compounds for cancer treatment. This position requires a PhD in analytical chemistry or a related field with extensive experience in drug discovery and development.

About the role

This role involves leading analytical development and product characterization activities, providing oversight and technical guidance for method development, validation, release, and stability testing at Contract Development and Manufacturing Organizations (CDMOs). The candidate will also serve as a subject matter expert for the physical and chemical characterization of New Chemical Entities (NCEs) at Contract Research Organizations (CROs).

Responsibilities

• Independently conceptualize, design, and conduct experiments to solve challenging problems using traditional and emerging analytical techniques.
• Maintain accurate lab records and ensure compliance with good documentation practices and regulatory guidelines.
• Develop and execute strategic plans for projects, both internally and externally, ensuring that product requirements are designed and delivered appropriately and in a timely manner for all stakeholders and customers at various stages of drug development.
• Provide technical guidance during investigations at CDMOs/CROs, collaborating with quality assurance teams.
• Create and review technical reports, data packages, and regulatory filings, including INDs, NDAs, and annual reports.
• Communicate effectively in project management, budget planning, progress tracking, and contract/PO/invoice coordination with finance, ensuring high-quality deliverables are met on time.

Requirements

• Ph.D. in analytical chemistry or related field with 3+ years of experience, or equivalent, in drug discovery and development.
• Demonstrated problem-solving skills, critical thinking, and ability to adapt quickly to changing priorities.
• Proven record of sustained laboratory achievement and innovation.
• Extensive hands-on experience in analytical technologies including UHPLC, GC, LC-MS, GC-MS, SFC, dissolution, disintegration, wet chemistry, DSC, TGA, PSD, XRPD, spectroscopic, and compendial methods.
• A thorough understanding of the underlying science and contemporary practice of various analytical technologies and their application to new drug candidates in preclinical through early and late-stage clinical development.
• Experience in writing and reviewing product specifications, method validation protocols/reports, analytical methods, and development reports.
• Knowledge of ICH and regulatory guidance.
• A strong attention to detail and prior experience working in a lab, GLP, and cGMP environment.

Qualifications

• Ph.D. in analytical chemistry or related field with 3+ years of experience, or equivalent, in drug discovery and development.
• Demonstrated problem-solving skills, critical thinking, and ability to adapt quickly to changing priorities.
• Proven record of sustained laboratory achievement and innovation.
• Extensive hands-on experience in analytical technologies including UHPLC, GC, LC-MS, GC-MS, SFC, dissolution, disintegration, wet chemistry, DSC, TGA, PSD, XRPD, spectroscopic, and compendial methods.
• A thorough understanding of the underlying science and contemporary practice of various analytical technologies and their application to new drug candidates in preclinical through early and late-stage clinical development.
• Experience in writing and reviewing product specifications, method validation protocols/reports, analytical methods, and development reports.
• Knowledge of ICH and regulatory guidance.
• A strong attention to detail and prior experience working in a lab, GLP, and cGMP environment.

Skills

• Strong communication and project management skills.
• Ability to work independently and efficiently in a collaborative, fast-paced, integrated, multidisciplinary team environment.
• Experience in working with CROs and CDMOs.

Benefits

• Competitive salary range of $150,000 - $180,000 for candidates working on-site in South San Francisco.
• Equal opportunity employer.

Pay

$150,000 - $180,000

Schedule

Full-time