QC Analytical Development Scientist

Job Summary:

Seeking a QC Analytical Development Scientist to support analytical development and GMP QC activities for AAV/gene therapy products.

Key Responsibilities:

• Develop, optimize, validate, qualify, and transfer HPLC-based analytical methods.
• Evaluate critical quality attributes including identity, purity, concentration, and impurities.
• Support GMP release, in-process, and stability testing.
• Troubleshoot analytical issues and support investigations, RCA, deviations, and CAPAs.
• Prepare and review SOPs, protocols, validation reports, and technical documents.
• Collaborate with QC, QA, Analytical Development, Manufacturing, Process Development, and Regulatory teams.
• Ensure compliance with cGMP, data integrity, and regulatory requirements.
• Provide technical guidance and training to laboratory personnel.

Required Skills:

• Strong HPLC method development, validation, troubleshooting, and transfer experience.
• Biopharmaceutical/GMP QC experience.
• Experience with AAV, viral vectors, biologics, or gene therapy strongly preferred.
• Knowledge of analytical validation, investigations, and data integrity.
• Strong technical writing and communication skills.