Remote Senior Director, Analytical Development Strategy

Openkrill

United States

Remote

USD 250,000 - 275,000

Full time

3 days ago

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Benefits offered by this job

Health benefits premium

Life insurance

AD&D

Disability benefits

401(k) match

Stock incentives

ESPP

Quarterly bonus

Wellness benefit

Generous PTO

Paid holidays & shutdowns

Job summary

Praxis Precision Medicines is seeking a Senior Director to lead Analytical Development for small molecules and oligonucleotides, defining scientific direction and building a high-performing team. You will drive method development, qualification, and lifecycle management, while coordinating with Development CMC, QA, Regulatory Affairs, and Clinical Supply to ensure readiness for IND/IMPD/NDA filings.

You will oversee external testing labs, ensure data integrity and GMP compliance, and contribute

Qualifications

A Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Organic Chemistry, or a related field with 15+ years in pharma/biotech, or an MS/BS with commensurate experience.
Experience developing/validating analytical methods and control strategies for drug substance/product across development to late-stage.
Direct small molecule analytical development experience; ASO/siRNA analytics preferred.
Proven track record authoring analytical CMC content for regulatory filings and health authority interactions.
Experience directing CDMO/CRO relationships and outsourced testing; able to identify issues and resolve them.
People leadership to build a technical team; strong communication across scientific, operational, and executive teams.
Knowledge of ICH, USP/EP/JP, and GMP; CNS/rare disease development is a plus.

Responsibilities

Set the analytical strategy for drug substance/product across portfolios and milestones.
Lead method development, qualification, validation, transfer, and lifecycle management with QA, Process Development, and Regulatory.
Prepare regulatory-ready analytical CMC content and represent analytical development with health authorities.
Oversee CDMOs/CROs, method transfers, stability programs, and investigations of out-of-spec results; address risks early.
Build and mentor a high-performing analytical team and define its structure as the portfolio grows.
Collaborate with cross-functional teams to align analytical deliverables with program decisions and timelines.