Senior Analytical Development Scientist, Small Molecules

Praxis Precision Medicines, Inc.; United States; Remote; USD 170,000 - 210,000; Full time

Benefits offered by this job

Medical & dental & vision coverage

Life insurance

AD&D

Disability benefits

401(k) matching

Stock incentives & ESPP

Quarterly bonus

Wellness benefits

Generous PTO & holidays

Job summary

Praxis Precision Medicines, Inc. is seeking a Principal Scientist, Analytical Development to lead analytical strategy for small molecule drug substances and products, coordinating across a virtual network of CMOs and partners.

This hands-on leadership role drives method development, qualification, transfer, and GMP testing throughout the lifecycle. You will partner with Drug Substance, Drug Product, Quality, Regulatory, and Manufacturing teams to establish robust analytical control strategies,

Qualifications

• Advanced degree in Analytical Chemistry or related discipline with 8+ years of industry experience.
• Experience in analytical development for small molecules and drug products, including solid dosage forms.
• Strong knowledge of US/EU cGMP requirements and analytical best practices.
• Experience managing external CRO/CMO networks and cross-functional programs.
• Experience supporting regulatory submissions and commercialization readiness.

Responsibilities

• Act as Analytical Lead for small molecule CMC programs.
• Lead method development, qualification, validation, transfer, and GMP testing.
• Develop phase-appropriate analytical control strategies and stability programs.
• Provide hands-on leadership for troubleshooting, impurity characterization, and method lifecycle management.
• Review analytical documentation including validation, certificates of analysis, and CMC reports.
• Direct and manage external CRO/CMO partners for high-quality execution.
• Support regulatory submissions and product lifecycle management.

Skills

Analytical chemistry

Small molecule development

cGMP

Leadership

Cross-functional leadership

CMC transfer

Regulatory submissions

External partners management

Education

PhD preferred

MS with experience

Tools

None

Job description

Praxis Precision Medicines, Inc. is seeking a Principal Scientist, Analytical Development to lead analytical strategy for small molecule drug substances and products, coordinating across a virtual network of CMOs and partners.

This hands-on leadership role drives method development, qualification, transfer, and GMP testing throughout the lifecycle. You will partner with Drug Substance, Drug Product, Quality, Regulatory, and Manufacturing teams to establish robust analytical control strategies,