Senior Manager, Analytical Development

Praxisprecisionmedicines

Remote
**
Analytical method development
Analytical method qualification
Analytical method validation
** Praxis Precision Medicines is seeking a Senior Manager for Analytical Development to oversee analytical projects involving small molecule drug substances and products, primarily in collaboration with Contract Development and Manufacturing Organizations (CDMOs). The role requires extensive experience in analytical method development and a strong understanding of regulatory compliance in drug development. **

Job Summary

  • The role involves supporting analytical deliverables of CMC programs by managing analytical testing in an external network, including review of data, methods, and reports.
  • Responsibilities include oversight and coordination of CMC stability and reference standard programs, and direct monitoring of external network providers for analytical development activities.
  • The position requires a Bachelor's degree in Analytical Chemistry or related discipline with 10+ years of industry experience, and strong knowledge of US and EU cGMP requirements.

Matching Summary

Match Score: 75

** Praxis Precision Medicines is seeking a Senior Manager for Analytical Development to oversee analytical projects involving small molecule drug substances and products, primarily in collaboration with Contract Development and Manufacturing Organizations (CDMOs). The role requires extensive experience in analytical method development and a strong understanding of regulatory compliance in drug development. **

Skills & Requirements

Must-have

  • analytical method development
  • analytical method qualification
  • analytical method validation
  • small molecule drug substance
  • drug product services
  • cGMP requirements

Nice-to-have

  • collaborative team environment
  • continuous improvement
  • phase-appropriate quality control

Key Requirements

  • 10+ years of industry experience
  • Bachelor's degree in Analytical Chemistry
  • Experience with small molecule drug substance
  • Experience with oral drug products
  • US and EU cGMP knowledge

Work Rights

Not specified

Tailored Resume

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