Senior Scientist – Bioassay Development & Tech Transfer

GlaxoSmithKline; Upper Providence (Delaware County); On-site; USD 110,000 - 140,000; Full time

Job summary

GlaxoSmithKline is seeking a Scientist/Senior Scientist to lead the development, validation, and tech transfer of cell-based bioassays for potency and GMP release. You will work within the Extended Characterization group of the Analytical Development Department to advance assay methods used in stability testing and critical quality assessments.

The role requires advanced biology training (PhD/ MSc) with hands-on cell biology and culture experience, and collaboration with SMEs to ensure robust,

Qualifications

• Ph.D. or Master’s with relevant experience in cell-based potency methods, or Bachelor’s with 5+ years in academic/biotech/pharma settings.
• 2+ years in cell biology and cell-based method development/troubleshooting.
• 2+ years of cell culture techniques for immortalized cell lines.

Responsibilities

• Develop and validate cell-based bioassays for characterization, comparability and GMP release of stability samples.
• Participate in early/late-phase validation and method transfer to commercial labs.
• Provide scientific input on method development focusing on MOA functional mechanisms.
• Collaborate with biology SMEs to establish GMP-suitable cell-based methods.
• Ensure regulatory compliance, data integrity, safety and quality per company policies.
• Independently conduct and manage experiments with increasing complexity.

Skills

Biopharmaceuticals

Bioprocessing

Cell Line Development

Drug Development

Experimental Methods

Molecular Cell Biology

Pharmaceutical Industry

Pharmaceutical Manufacturing

Quality by Design

Regulatory Submissions

Simulation Models

Technical Writing

Technology Transfer

Education

Ph.D. in Biology / Molecular Biology

Master’s degree in Biology or related field

Bachelor’s degree with 5+ years cell-based potency methods experience

Tools

Hamilton

Tecan

HP D300e

Flow Cytometry / FACS

Job description

GlaxoSmithKline is seeking a Scientist/Senior Scientist to lead the development, validation, and tech transfer of cell-based bioassays for potency and GMP release. You will work within the Extended Characterization group of the Analytical Development Department to advance assay methods used in stability testing and critical quality assessments.

The role requires advanced biology training (PhD/ MSc) with hands-on cell biology and culture experience, and collaboration with SMEs to ensure robust,