Quality Control Scientist

Key Skills
HPLC Method Development | HPLC/UPLC | Analytical Method Optimization | Method Validation | Method Transfer | AAV Viral Vector Characterization | Gene Therapy Products | GMP QC Testing | Biopharmaceutical Analytical Development | Stability Testing | Release Testing | Root Cause Analysis | Deviation Investigation | CAPA | cGMP Compliance | Data Integrity

Job Summary
We are seeking an experienced QC Analytical Development Scientist to provide scientific and technical leadership in support of analytical development and GMP Quality Control activities for gene therapy products. The successful candidate will lead the development, optimization, qualification, validation, and transfer of HPLC-based analytical methods for AAV viral vector products while supporting routine GMP QC testing, troubleshooting, and product development activities.

Key Responsibilities

• Lead the development, optimization, qualification, validation, and transfer of HPLC-based analytical methods for AAV viral vector products.
• Develop and implement analytical methods to assess critical quality attributes, including identity, purity, concentration, and product-related impurities, as applicable.
• Support routine GMP QC testing, including in-process, release, and stability testing.
• Troubleshoot complex analytical issues, investigate atypical results, and support root cause analysis, deviations, and CAPAs.
• Author and review analytical procedures, SOPs, protocols, validation reports, and technical documentation.
• Collaborate with Analytical Development, QC, QA, Process Development, Manufacturing, and Regulatory Affairs teams to support product development and lifecycle activities.
• Ensure compliance with cGMP, data integrity, and applicable regulatory requirements.
• Provide technical leadership, mentorship, and training to scientists and laboratory personnel.

Required Qualifications

• Experience in HPLC method development, optimization, troubleshooting, validation, and transfer within the biopharmaceutical industry.
• Experience supporting GMP QC testing and analytical method implementation.
• Knowledge of analytical techniques for AAV viral vectors or other biologic products.
• Strong understanding of analytical method validation, laboratory investigations, and data integrity requirements.
• Strong scientific problem-solving, technical writing, and communication skills.
• Ability to collaborate effectively with cross-functional teams in a regulated pharmaceutical environment.

Preferred Qualifications

• Experience working with AAV viral vectors or gene therapy products.
• Experience with biopharmaceutical analytical development and characterization.
• Knowledge of analytical techniques used to assess product identity, purity, concentration, and impurities.
• Experience supporting analytical method transfers, deviations, CAPA, and root cause investigations.
• Experience providing technical leadership, mentorship, and training to laboratory personnel.

Benefits
Eligible employees may have access to benefits offered by UPT Inc., including medical, dental, vision, and other benefits, subject to eligibility requirements and applicable plan terms.

UPT Inc. is an Equal Opportunity Employer. We consider qualified applicants for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other characteristic protected by applicable law.