Principal Scientist, CMC Analytical

Responsibilities

• Lead analytical development and QC strategy, ensuring robust phase-appropriate product quality controls
• Act as primary technical liaison with CDMO and contract laboratories, resolving complex analytical issues
• Direct analytical method development for drug substances, handling qualification and validation processes
• Perform detailed reviews and complex interpretations of analytical data from various testing methods
• Identify trends in complex data impacting product quality and provide program-level risk assessments
• Own the technical accuracy and regulatory submission of analytical data packages, including authoring relevant documentation
• Mentor junior scientists and analysts, enhancing team analytical capabilities

Qualifications

• Ph.D. in Analytical Chemistry, Chemistry, Biochemistry or related field
• 10+ years in QC laboratory operations or analytical method development, preferably with small-molecule oral solid dosage products
• Significant sponsor-side pharmaceutical experience, with veterinary pharmaceutical experience helpful
• Expertise in analytical chemistry for drug substances and products, including method development and quality control
• Understanding of cGMP, ICH/VICH, FDA, and EMA analytical standards

Benefits

• Full-coverage health insurance for you and your dependents
• $1,000 home office equipment stipend
• $1,200/year learning budget for professional development
• $250/month wellness budget for personal well-being expenses
• Extended weekend policy with all 3-day weekends becoming 4-day weekends
• Unlimited vacation and paid holidays
• Paw-ternity leave for adopting a pet
• Competitive salary with equity options for new hires

Pay

$150,000 – $190,000 annually

Schedule

Remote - US based candidates only, no visa sponsorship available