Principal Scientist, Analytical Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the Analytical Lead for small molecule CMC initiatives.

• Oversee the development, qualification, validation, transfer, and GMP testing of analytical methods in collaboration with both internal teams and external CRO/CMO partners.

• Create and execute phase-appropriate analytical control strategies, specifications, and stability programs.

• Provide technical expertise for analytical troubleshooting, data interpretation, impurity characterization, method lifecycle management, and analytical investigations.

• Evaluate and authorize analytical methods, validation and qualification reports, stability reports, specifications, certificates of analysis, and other CMC documentation.

• Direct and oversee external CRO/CMO analytical partners.

• Assist with regulatory submissions, ensure commercialization readiness, and support product lifecycle management.

• Collaborate with Drug Substance, Drug Product, Quality, Regulatory, Manufacturing, and external teams to enhance scalable analytical processes.

⛳️ Requirements

• Advanced degree in Analytical Chemistry or a related field; PhD is preferred, but a Master’s with substantial industry experience will be considered.

• More than 8 years of relevant experience in the industry.

• Extensive experience in analytical development for small molecule drug substances and drug products, particularly solid oral dosage forms.

• Profound knowledge of impurity characterization, assay and purity testing, stability assessment, and GMP analytical control strategies.

• Strong comprehension of US and EU cGMP regulations and analytical best practices.

• Proven experience in supporting CMC development encompassing analytical development, regulatory submissions, method validation and transfer, and commercialization efforts.

• Experience in managing external CRO/CMO analytical networks.

• Well-versed in quality systems, reference standards, stability programs, specifications, and compendial testing requirements.

• Willingness and flexibility to travel as required.

🏝️ Benefits

• 99% of the premium covered for medical, dental, and vision plans.

• Company-paid life insurance.

• AD&D benefits.

• Disability benefits.

• Optional plans to customize coverage.

• Dollar-for-dollar 401(k) matching up to 6% on eligible contributions.

• Long-term stock incentives.

• Employee Stock Purchase Plan (ESPP).

• Discretionary quarterly bonuses.

• Highly flexible wellness benefit.

• Generous paid time off (PTO).

• Paid holidays.

• Company-wide shutdowns.