Principal Scientist, Analytical Development

The role

The Principal Scientist, Analytical Development leads analytical development strategies for small molecule drug substances and drug products. This role involves managing analytical methods and control strategies across a virtual network of CMOs and external partners.

What you will do

• Serve as the Analytical Lead for small molecule CMC programs.
• Lead analytical method development, qualification, validation, transfer, and GMP testing activities.
• Develop and implement phase-appropriate analytical control strategies, specifications, and stability programs.
• Provide technical leadership for analytical troubleshooting, data interpretation, and impurity characterization.
• Review and approve analytical documentation including methods, validation reports, and stability reports.
• Direct and manage external CRO/CMO analytical partners.
• Provide strategic and technical expertise to support regulatory submissions and commercialization readiness.

Required qualifications

• Advanced degree in Analytical Chemistry or a related discipline.
• 8+ years of relevant industry experience.
• Industry experience in analytical development for small molecule drug substances and drug products, including solid oral dosage forms.
• Knowledge of analytical techniques and strategies for small molecules, including impurity characterization, assay and purity testing, and stability assessment.
• Understanding of US and EU cGMP requirements and analytical best practices.
• Experience supporting CMC development across multiple stages.
• Experience managing external CRO/CMO analytical networks.
• Working knowledge of quality systems, reference standards, stability programs, specifications, and compendial testing requirements.

Nice to have

• PhD preferred

Benefits

• 99% of the premium paid for medical, dental and vision plans
• Company-paid life insurance
• AD&D
• Disability benefits
• Voluntary plans to personalize coverage
• 401(k) matching dollar-for-dollar up to 6%
• Long-term stock incentives
• ESPP
• Discretionary quarterly bonus
• Flexible wellness benefit
• Generous PTO
• Paid holidays and company-wide shutdowns

About the company

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders. The company focuses on developing high impact medicines for patients and families affected by complex brain disorders.