QC Analytical Development Scientist

Job Title: QC Analytical Development Scientist



Location: Houston, TX
Pay: $35-40/hr on W2
Work Environment: Onsite

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.

Name: Soundarya Kondra



Email: View email address on us.fitly.work



Phone: View phone number on us.fitly.work



INTELLECTT INC

Benefits:
Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

Equal Employment Opportunity:
Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.