Analytical Development Lead – Oligonucleotides (Remote)

Praxis Precision Medicines, Inc.; United States; Remote; USD 170.000 - 190.000; Vollzeit

Zusammenfassung

Praxis Precision Medicines, Inc. seeks a Principal Scientist in Analytical Development focused on oligonucleotide therapeutics with secondary support for small molecules.

Remote work in the United States is offered, with travel as needed, to advance analytical strategies from development through manufacturing within a virtual network of partners. The candidate will lead method development, qualification, validation, transfer and GMP testing, shaping robust analytical control strategies and

Qualifikationen

• Advanced degree in Analytical Chemistry or related discipline with 5–7+ years of industry experience.
• Strong experience in analytical development for oligonucleotide drug substances/products.
• Experience supporting small molecule drug substances and solid oral dosage forms preferred.
• Deep knowledge of analytical techniques relevant to oligonucleotides, impurity characterization, stability assessment, and GMP control strategies.
• Strong understanding of US/EU cGMP requirements and analytical best practices for drug substances/products.
• Experience supporting CMC development across regulatory submissions, validation, and commercialization.
• Experience managing external CRO/CMO analytical networks and partnerships.
• Knowledge of quality systems, reference standards, stability programs, and compendial testing requirements.

Aufgaben

• Serve as Analytical Lead across CMC programs with primary responsibility for oligonucleotide analytical development and support for small molecule programs.
• Lead analytical method development, qualification, validation, transfer, and GMP testing across internal teams and external partners.
• Drive troubleshooting, data interpretation, method lifecycle management, and review of validation/stability/CoA documents.
• Design and implement phase-appropriate analytical control strategies, specifications, and stability programs for oligonucleotide and small molecule substances/products.
• Direct and manage CRO/CMO analytical partners to ensure high-quality execution and communication.
• Collaborate across functions to strengthen CMC operations and scalable practices within the analytical function.
• Contribute to regulatory filings, commercialization readiness, and lifecycle management.

Kenntnisse

Analytical development

Oligonucleotide analytics

GMP testing

Method development

CRO/CMO management

Ausbildung

PhD in Analytical Chemistry

Masters with significant industry experience

Tools

HPLC

LC-MS

Jobbeschreibung

Praxis Precision Medicines, Inc. seeks a Principal Scientist in Analytical Development focused on oligonucleotide therapeutics with secondary support for small molecules.

Remote work in the United States is offered, with travel as needed, to advance analytical strategies from development through manufacturing within a virtual network of partners. The candidate will lead method development, qualification, validation, transfer and GMP testing, shaping robust analytical control strategies and