Oligonucleotide Analytical Development Lead – Remote

Praxis Precision Medicines, Inc.; Boston (MA); Remote; USD 170,000 - 190,000; Full time

Benefits offered by this job

Medical, dental & vision insurance

Company-paid life insurance

AD&D and disability benefits

401(k) match

Stock incentives and ESPP

Discretionary quarterly bonus

Generous PTO and holidays

Job summary

Praxis Precision Medicines is seeking a Principal Scientist, Analytical Development to lead oligonucleotide analytical strategy across our development and manufacturing partners. You will shape phase-appropriate control strategies, drive method development and validation, and oversee CRO/CMO collaborations to deliver robust analytical capabilities for CNS therapies.

The role requires deep expertise in oligonucleotide analytics, GMP testing, and cGMP compliance, with a track record of

Qualifications

• Advanced degree (PhD preferred; Master’s with significant industry experience considered) in Analytical Chemistry or related discipline.
• 5–7+ years of industry experience in analytical development.
• Strong industry experience in analytical development for oligonucleotide drug substances and/or drug products.
• Experience supporting small molecule drug substances and solid oral dosage forms preferred.
• Deep knowledge of analytical techniques for oligonucleotides including impurity characterization, stability assessment, and GMP control strategies.
• Strong understanding of US and EU cGMP requirements for drug substance and drug product development.
• Experience managing external CRO/CMO analytical networks and partnerships.
• Quality systems, reference standards, stability programs, and compendial testing.

Responsibilities

• Serve as Analytical Lead across CMC programs, with primary responsibility for oligonucleotide analytical development activities and support for small molecule programs.
• Lead analytical method development, qualification, validation, transfer, and GMP testing activities across internal teams and external partners.
• 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.

Skills

Oligonucleotide analytics

Analytical development

cGMP knowledge

Cross-functional collaboration

Education

PhD in Analytical Chemistry or related

Masters with significant industry experience considered

Job description

Praxis Precision Medicines is seeking a Principal Scientist, Analytical Development to lead oligonucleotide analytical strategy across our development and manufacturing partners. You will shape phase-appropriate control strategies, drive method development and validation, and oversee CRO/CMO collaborations to deliver robust analytical capabilities for CNS therapies.

The role requires deep expertise in oligonucleotide analytics, GMP testing, and cGMP compliance, with a track record of