Lead Analytical Development - Small Molecules (Remote)

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

Job summary

Praxis Precision Medicines, Inc. is seeking a Principal Scientist, Analytical Development, to lead analytical strategies for small molecules across the drug lifecycle. You will oversee method development, validation, transfer and GMP testing across internal teams and external CMOs, shaping control strategies and regulatory readiness.

Remote work with travel expectations will apply. You will collaborate with Drug Substance, Drug Product, Quality and Regulatory teams to build scalable, compliant

Qualifications

• Advanced degree (PhD preferred; Master’s with significant industry experience considered) in Analytical Chemistry or related discipline with 8+ years of industry experience.
• Experience in analytical development for small molecule drug substances and drug products, including solid oral dosage forms.
• Strong knowledge of US and EU cGMP requirements and analytical best practices for drug substance and drug product development.
• Experience supporting CMC development, regulatory submissions, method validation and transfer, and commercialization activities.
• Experience managing external CRO/CMO analytical networks and partnerships.

Responsibilities

• Serve as Analytical Lead for small molecule CMC programs, providing technical leadership across drug substance and drug product analytical development.
• Lead analytical method development, qualification, validation, transfer, and GMP testing with internal and external partners.
• Develop phase-appropriate control strategies, specifications, and stability programs.
• Provide hands-on leadership for troubleshooting, impurity characterization, method lifecycle management, and investigations.
• Review and approve analytical documentation including methods, validation, stability, and COAs.
• Direct external CRO/CMO partners to ensure quality, timely delivery, and continuous improvement.
• Support regulatory submissions, commercialization readiness, and lifecycle management with cross-functional collaboration.

Skills

Analytical chemistry

Small molecule development

Cross-functional leadership

GMP/written controls

Education

PhD in Analytical Chemistry

Master’s with industry experience considered

Job description

Praxis Precision Medicines, Inc. is seeking a Principal Scientist, Analytical Development, to lead analytical strategies for small molecules across the drug lifecycle. You will oversee method development, validation, transfer and GMP testing across internal teams and external CMOs, shaping control strategies and regulatory readiness.

Remote work with travel expectations will apply. You will collaborate with Drug Substance, Drug Product, Quality and Regulatory teams to build scalable, compliant