North AmericaFull TimeEngineering
Remotely
analytical chemistryvalidationgmpcgmp21 cfr part 11method transfereu gmp annex 11
Job Description
📋 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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