Senior QC & Analytical Scientist (Gene Therapy)

Socket.dev; Houston (TX); On-site; USD 95,000 - 140,000; Full time

Job summary

Socket.dev in Houston seeks a Sr Scientist to lead analytical method development, qualification/validation, and GMP testing for gene therapy products. You will oversee method transfer, troubleshoot complex assays, and mentor junior staff in a fast-paced QC environment.

The role emphasizes HPLC-based analytical development, data integrity, and cross-functional collaboration with Process Development, Manufacturing, QA, and Regulatory Affairs to support timelines and product release.

Qualifications

• Ph.D. or M.S. in Biology, Biotechnology, Bioengineering, Chemistry, Pharmaceutical Sciences or other relevant scientific field.
• 6-8+ years of relevant industry experience with a Ph.D. or 8-10+ years with M.S., preferably supporting biologics, viral vector, cell and gene therapy products.
• Demonstrated experience in analytical method development, optimization, qualification/validation, transfer, troubleshooting, and/or implementation into routine GMP testing.
• Experience applying QbD/DOE approaches to analytical development and optimization activities.
• Strong working knowledge of cGMP laboratory requirements and regulatory expectations.
• Ability to manage multiple analytical projects and priorities while meeting timelines.
• Hands-on experience with multiple analytical technologies used for viral vector or biologics release and characterization.
• Excellent written and oral communication skills and cross-functional collaboration.

Responsibilities

• Lead analytical method development, qualification/validation, transfer, and troubleshooting.
• Provide technical oversight for GMP testing of raw materials, in-process samples, and product materials.
• Lead method transfers from various sites and ensure analysts are trained and qualified.
• Design and execute analytical development studies using sound experimental approaches.
• Draft and review technical documents, SOPs, and validation reports.

Skills

Analytical method development

GMP testing

HPLC methods

qPCR/ddPCR

ELISA

Statistical analysis

DOE/QbD

Cross-functional teamwork

Education

Ph.D. in Biology/Biotechnology

M.S. in Biology/Biotechnology

Tools

HPLC instrumentation

qPCR instruments

ELISA readers

Analytical method transfer

Job description

Socket.dev in Houston seeks a Sr Scientist to lead analytical method development, qualification/validation, and GMP testing for gene therapy products. You will oversee method transfer, troubleshoot complex assays, and mentor junior staff in a fast-paced QC environment.

The role emphasizes HPLC-based analytical development, data integrity, and cross-functional collaboration with Process Development, Manufacturing, QA, and Regulatory Affairs to support timelines and product release.