QC Analytical Development Scientist

Hello,

I hope you're doing well.

My name is Mahalakshmi, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity QC Analytical Development Scientist based Houston, TX (On-Site), at one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at

mahalakshmi.n@intellectt.com

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.

Benefits: Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements
Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off (PTO): No PTO other than that required by applicable state and local laws
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.

Thanks & Regards,
Mahalakshmi
Junior Recruiter
Intellectt Inc

mahalakshmi.n@intellectt.com