Senior Director, Head of Analytical Development

The role

You will lead Analytical Development across small molecule and oligonucleotide portfolios. You will set scientific direction, build the team, and ensure methods, specifications, and control strategies are ready for development stages through NDA/MAA approval.

What you will do

• Set the analytical strategy for drug substance and drug product.
• Lead analytical method development, qualification, validation, transfer, and lifecycle management.
• Establish specifications, comparability approaches, and control strategies.
• Author and review analytical CMC content for regulatory submissions.
• Represent Analytical Development in health authority interactions.
• Oversee CDMOs, CROs, and contract testing laboratories.
• Hire, coach, and develop the analytical team.
• Partner with Process Development, Formulation Development, Clinical Supply, Quality, and Regulatory Affairs.
• Lead CMC teams and represent the CMC function on cross functional program teams.
• Champion data integrity, GMP compliance, and continuous improvement.

Required qualifications

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Organic Chemistry, or a related field and 15+ years of relevant pharmaceutical or biotech experience; or an M.S./B.S. with commensurately greate
• Deep experience developing and validating analytical methods and establishing control strategies for drug substance and drug product.
• Direct small molecule analytical development experience.
• Record of authoring and defending analytical CMC content in regulatory filings and participating in health authority interactions.
• Experience directing CDMO/CRO relationships and outsourced analytical testing.
• People leadership experience.
• Strong working knowledge of ICH guidelines, USP/EP/JP compendial requirements, and current GMP regulations.
• Clear communication and sound judgment.

Nice to have

• Experience with ASO, siRNA, or other nucleic acid therapeutic analytics
• Experience in CNS or rare disease development

Benefits

• 99% of the premium paid for medical, dental and vision plans
• Company-paid life insurance
• AD&D
• Disability benefits
• Voluntary plans
• Dollar-for-dollar 401(k) match 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's core values are Trust, Ownership, Curiosity and Results.