Praxis Precision Medicines, Inc.
Principal Scientist, Analytical Development, Oligo and Small Molecule
United States - Remote · Principal
Sponsorship not specifiedDetected 63 days ago
Product ManagementGMPLeadershipCommunication
About the role
- This is a highly cross-functional, hands-on leadership role requiring close partnership with Drug Substance, Drug Product, Quality, Regulatory, and Manufacturing teams to ensure robust, scalable, and compliant analytical control strategies.
Responsibilities
- Serve as Analytical Lead across CMC programs, with primary responsibility for oligonucleotide analytical development activities and support for small molecule programs
- Drive technical troubleshooting, data interpretation, method lifecycle management, and review of analytical documentation including validation reports, stability reports, specifications, and CoAs
- Design and implement phase-appropriate analytical control strategies, specifications, and stability programs for oligonucleotide and small molecule drug substances and drug products
- Direct and manage CRO/CMO analytical partners to ensure high-quality execution, strong communication, and continuous operational improvement
- Collaborate cross-functionally to strengthen CMC operations, improve processes, and establish scalable technical and business practices across the analytical function
- Contribute strategic and technical expertise to support regulatory filings, commercialization readiness, and ongoing product lifecycle management
Requirements
- Advanced degree (PhD preferred; Master's with significant industry experience considered) in Analytical Chemistry or related discipline with 5-7+ years of industry experience
- Experience managing external CRO/CMO analytical networks and building productive technical partnerships
Nice to have
- This role is particularly focused on advancing oligonucleotide-based therapeutics, while also supporting small molecule programs across the portfolio.
- The successful candidate will help shape an agile, forward-looking analytical development function capable of supporting innovative CNS therapies from early development through commercialization.
- Advanced degree (PhD preferred
- Master's with significant industry experience considered) in Analytical Chemistry or related discipline with 5-7+ years of industry experience
- Strong industry experience in analytical development for oligonucleotide drug substances and/or drug products required
- Experience supporting small molecule drug substances and solid oral dosage forms strongly preferred
- Deep knowledge of analytical techniques relevant to oligonucleotides, including impurity characterization, stability assessment, and GMP control strategies
- Strong understanding of US and EU cGMP requirements and analytical best practices for drug substance and drug product development
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