Senior Director: Head of Analytical Development (Remote)

Praxis Precision Medicines, Inc.; Northern (KY); Remote; USD 250,000 - 275,000; Full time

Benefits offered by this job

Bonus program

401(k) matching

Stock options

ESPP

Job summary

Praxis Precision Medicines, Inc. seeks a Senior Director, Head of Analytical Development to lead strategy for analytical development across small molecules and nucleic acids.

You will guide method development, qualification, validation, and lifecycle management, while directing external laboratories and driving regulatory-ready CMC content. You will build and mentor a high-performing team, collaborate with Development CMC, Quality, Regulatory Affairs, and Clinical Supply, and ensure analytical

Qualifications

• Ph.D. or equivalent with 15+ years in pharma/biotech analytical development.
• Experience developing/validating analytical methods for drug substances and products.
• Experience with ASO/siRNA analytics is preferred.

Responsibilities

• Set analytical strategy across small molecules and oligonucleotides.
• Lead method development, qualification, validation, transfer, and lifecycle management.
• Prepare regulatory-ready analytical CMC content for submissions.
• Oversee external laboratories and manage outsourcing relationships.
• Build and lead a high-performing analytical team.
• Collaborate with cross-functional program teams to align analytical deliverables.

Skills

Analytical method development

Method validation

Regulatory submissions

Cross-functional leadership

GMP compliance

ICH guidelines

Team leadership

CDMO/CRO management

Education

Ph.D. in Analytical Chemistry/Pharmaceutical Sciences/Organic Chemistry

MS/BS with extensive pharmaceutical experience

Tools

HPLC/LC-MS

Job description

Praxis Precision Medicines, Inc. seeks a Senior Director, Head of Analytical Development to lead strategy for analytical development across small molecules and nucleic acids.

You will guide method development, qualification, validation, and lifecycle management, while directing external laboratories and driving regulatory-ready CMC content. You will build and mentor a high-performing team, collaborate with Development CMC, Quality, Regulatory Affairs, and Clinical Supply, and ensure analytical