Manager, Analytical Sciences - Commercial

Added
7 hours ago
Type
Full time
Salary
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Related skills

validation gmp analytical chemistry cgmp 21 cfr part 11

📋 Description

  • Lead analytical strategies for commercial products
  • Manage method transfers, validations, lifecycle activities
  • Support process performance qualification and stability programs
  • Review protocols, reports, COA, and audit trails
  • Oversee CDMOs and external labs for timely deliverables
  • Provide on-site analytical support during campaigns and inspections

🎯 Requirements

  • Bachelor’s in Chemistry or related field; 7+ years in analytical chemistry in GMP
  • Experience supporting commercial small-molecule programs
  • Strong knowledge of small-molecule substances and dosage forms
  • Hands-on method transfer, validation, troubleshooting, lifecycle Mgmt
  • Review data, chromatographic integrations, and ALCOA+/21 CFR Part 11
  • Knowledge of US/EU cGMP and ICH guidelines

🎁 Benefits

  • Annual base salary: $115,000–$140,000 USD
  • Medical, dental, vision; most premiums covered
  • Employer-funded healthcare support and voluntary plans
  • Company-paid life, AD&D, disability insurance
  • 401(k) with 6% employer match
  • Stock incentives and ESPP
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