Senior QC & Analytical Development Scientist - Gene Therapy

PACKGENE BIOTECH INC; Houston (TX); On-site; USD 120,000 - 160,000; Full time

Job summary

PACKGENE BIOTECH INC. seeks a Sr Scientist to lead analytical development and GMP QC activities for gene therapy products at the Houston headquarters. The role focuses on method development, qualification/validation, transfer, and troubleshooting across HPLC, qPCR/ddPCR, and related platforms.

You will mentor junior scientists, oversee technical reviews, and collaborate with Process Development, Manufacturing, QA, and Regulatory teams to ensure timely project delivery and assay robustness.

Qualifications

• Ph.D. or M.S. in Biology, Biotechnology, Chemistry or related field with 6–8+ years (Ph.D.) or 8–10+ years (M.S.).
• Experience in analytical method development, qualification/validation, transfer, troubleshooting, and GMP testing.
• Strong knowledge of cGMP practices and regulatory expectations for analytical labs.
• Experience with multiple analytical technologies for viral vector or biologics release.
• Ability to mentor and lead junior scientists and cross-functional teams.

Responsibilities

• Lead analytical method development and qualification/validation programs for gene therapy products.
• Oversee method transfer, comparability, and root-cause investigations with technical reports.
• Provide technical oversight for GMP testing of raw materials, in-process samples, drug product, and stability samples.
• Serve as SME for analytical methods and platforms (qPCR/ddPCR, ELISA, HPLC, electrophoresis, cell-based assays).
• Design experiments, develop study strategies, acceptance criteria, and data interpretation.
• Draft, review, and approve SOPs, protocols, and study reports; ensure data integrity and compliant documentation.
• Mentor junior staff and coordinate cross-functional activities with Process Development, Manufacturing, QA, and Regulatory.
• Support client interactions and audits as a technical expert for analytic development and testing timelines.

Skills

Analytical method development

QbD/DOE

GMP testing

Data analysis

Leadership

Education

Ph.D. or M.S. in biology/chemistry/biotech

Tools

qPCR/ddPCR

HPLC

ELISA

Job description

PACKGENE BIOTECH INC. seeks a Sr Scientist to lead analytical development and GMP QC activities for gene therapy products at the Houston headquarters. The role focuses on method development, qualification/validation, transfer, and troubleshooting across HPLC, qPCR/ddPCR, and related platforms.

You will mentor junior scientists, oversee technical reviews, and collaborate with Process Development, Manufacturing, QA, and Regulatory teams to ensure timely project delivery and assay robustness.