Senior Scientist, QC & Analytical Development (QCAD)

PackGene Biotech, Inc.; Houston (TX); On-site; USD 120,000 - 180,000; Full time

Job summary

PackGene Biotech, Inc. is seeking a QCAD Scientist I/II/Sr Scientist to lead analytical method development and GMP QC activities for gene therapy products. The role centers on HPLC methods while spanning other analytical modalities in a fast-paced, regulated environment.

The Senior Scientist will mentor staff, address method lifecycle, and collaborate with Process Development, Manufacturing, QA, and Regulatory Affairs to ensure robust testing and timely product release.

Qualifications

• Ph.D. or MS in a relevant scientific field.
• 6–8+ years of industry experience with a Ph.D. or 8–10+ years with an MS.
• Demonstrated experience in analytical method development, qualification/validation, and transfer.
• Experience with GMP testing and analytical lifecycle management.
• Strong knowledge of cGMP laboratory requirements and data integrity.

Responsibilities

• Lead analytical method development, qualification/validation and transfer.
• Oversee GMP testing of materials, in-process samples, and products.
• Provide technical leadership and mentorship within the QCAD team.
• Collaborate with cross-functional groups for method lifecycle management.
• Support client audits and regulatory inspections as SME.

Skills

Analytical method development

HPLC methods

qPCR/ddPCR

GMP knowledge

Data analysis/Statistics

Education

Ph.D. in Biology/Biotechnology

MS in a related scientific field

Tools

qPCR/ddPCR instrumentation

HPLC instrument qualification

ELISA

Job description

PackGene Biotech, Inc. is seeking a QCAD Scientist I/II/Sr Scientist to lead analytical method development and GMP QC activities for gene therapy products. The role centers on HPLC methods while spanning other analytical modalities in a fast-paced, regulated environment.

The Senior Scientist will mentor staff, address method lifecycle, and collaborate with Process Development, Manufacturing, QA, and Regulatory Affairs to ensure robust testing and timely product release.