Analytical Scientist / QC Analyst – Cell & Gene Therapy (cGMP)

We are seeking an Analytical Scientist / QC Analyst to join a growing Cell & Gene Therapy team supporting analytical development and quality control activities. This role will focus on method validation, analytical testing, and cGMP compliance to support manufacturing and product quality.

You will collaborate with cross-functional teams to ensure successful development, validation, and transfer of analytical methods for innovative therapies.

Key Responsibilities

• Execute analytical method validation, transfer, and troubleshooting
• Perform QC testing (e.g., PCR, ELISA, HPLC, etc.) in a cGMP environment
• Support process development, in-process controls, and product release testing
• Write/review SOPs, protocols, and validation reports
• Perform equipment qualification and maintenance
• Analyze data and ensure results meet acceptance criteria
• Support audits, investigations, and regulatory compliance
• Collaborate with cross-functional and global teams

Qualifications

• Bachelor’s or Master’s degree in Biology, Chemistry, Biochemistry, or related field
• 1–3+ years of experience in analytical development or QC (biotech/pharma)
• Knowledge of cGMP/GxP environments
• Experience with analytical techniques such as PCR, ELISA, HPLC, or chromatography
• Strong documentation, analytical, and communication skills