Senior Manager Analytical Operations

📋 Description

• Manage analytical development, QC, and stability at CDMOs
• Collaborate with Drug Substance/Product and QA teams
• Oversee method development, transfer, validation, and stability programs
• Coordinate data trending and regulatory-relevant reports
• Ensure compliance with ICH, USP, and cGMP guidelines
• Support US regulatory filings and post-approval activities

🎯 Requirements

• 10+ years in Analytical Development and/or QC in pharma
• Expertise in stability program management and data analysis
• Strong communication with vendors and cross-functional teams
• Experience with cGMP, ICH, and regulatory submissions
• Proficiency with JMP or similar data tools; QA/LIMS experience
• Ability to travel 5-15% and adapt to shifting priorities

🎁 Benefits

• Competitive compensation and annual bonus
• 401(k) with employer match and ESPP
• Comprehensive health benefits; fully paid premiums for you and dependents
• Hybrid work model; remote options with occasional onsite visits
• Paid time off, flexible scheduling, and parental leave