Senior Director, Head of Analytical Development

The posting, as Praxis Precision Medicines, Inc. wrote it

The Opportunity

We are looking for a Senior Director to lead Analytical Development across our small molecule and oligonucleotide portfolios. You will set the scientific direction, build the team, and ensure our methods, specifications, stability programs, and control strategies are ready for each stage of development, from pre-IND work through potential NDA/MAA approval.

This is a hands-on leadership role in a growing, agile organization. You will make consequential technical decisions, work closely with colleagues across Development CMC, Quality, Regulatory Affairs, and Clinical Supply, and hold external partners to a high standard. Your work will help move promising molecules toward medicines for patients.

Primary Responsibilities

• Set the analytical strategy. Define and execute an approach for drug substance and drug product across the small molecule and oligonucleotide portfolios. Make clear choices about what each program needs now and what it will need at the next clinical or regulatory milestone.
• Build reliable methods and controls. Lead analytical method development, qualification, validation, transfer, and lifecycle management. Establish specifications, comparability approaches, and control strategies with Process Development, Quality, and Regulatory Affairs.
• Deliver regulatory-ready science. Author and review analytical CMC content for IND, IMPD/CTA, and NDA/MAA submissions. Represent Analytical Development in health authority interactions and explain the science clearly under scrutiny.
• Lead external execution. Oversee CDMOs, CROs, and contract testing laboratories, including method transfers, stability programs, and investigations of out-of-specification or out-of-trend results. Surface risks early and drive them to resolution.
• Build the function. Hire, coach, and develop a strong analytical team. Shape its structure and capabilities as the portfolio grows, while giving people clear ownership and direct, useful feedback.
• Connect the work to program decisions. Partner with Process Development, Formulation Development, Clinical Supply, Quality, Regulatory Affairs, and program teams so analytical deliverables support sound decisions and meet program timelines. Lead CMC teams and represent CMC function on cross functional program teams.
• Raise the standard. Champion data integrity, GMP compliance, and continuous improvement. Stay current with analytical technologies and regulatory expectations, and apply new approaches when they will improve the work.

Qualifications and Key Success Factors

• A 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 greater experience.
• Deep experience developing and validating analytical methods and establishing control str

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rapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust , Ownership , Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE ® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.

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