Lead Analytical Scientist - Drug Development

GlaxoSmithKline; Upper Providence (Delaware County); On-site; USD 130,000 - 195,000; Full time

Job summary

GlaxoSmithKline seeks a senior analytical scientist to lead a small team delivering method development, validation, and lifecycle management across multiple projects in drug development. You will partner with internal teams and external labs to design studies for product characterization and transfer methods for GMP testing.

The role emphasizes regulatory submission support, scientific documentation, and mentorship to advance career growth while driving high-impact solutions for patients.

Qualifications

• Relevant degree in chemistry, biochemistry, analytical science, or related field.
• 6+ years (Ph.D.) or 8+ years (M.S.) or 10+ years (B.S.) in analytical development or laboratory leadership in the pharmaceutical industry.
• Experience supporting CMC activities and contributing to regulatory submissions.
• Experience with chromatographic and other separation techniques (for example HPLC, UHPLC) and common detectors.
• Experience in analytical method development, qualification or validation, and method transfer.
• Experience working with cross-functional teams and external partners.
• Prior people leadership, mentoring, or matrix team leadership experience.

Responsibilities

• Lead and coach a team to deliver analytical method development, validation, and lifecycle management across multiple projects, primarily for small molecule DS/DP.
• Own technical strategy for assigned projects and coordinate execution with internal and external partners.
• Design and oversee execution studies for product and process characterization and control strategy definition, stability testing, and release.
• Oversee method transfer, troubleshooting, and technical readiness for GMP testing.
• Author and review scientific documentation to support regulatory filings and quality systems.
• Mentor colleagues, promote a safe laboratory culture, and support continuous improvement.

Skills

Analytical Chemistry

Analytical Instrumentation

Analytical Laboratory

Analytical Thinking

Automation Technology

Bioprocessing

Chemical Processes

Data Analysis Tools

Dosage Forms

Drug Development

Matrix Leadership

Method Development

Technical Problem-Solving

Education

Relevant degree in chemistry/biochemistry/analytical science

Advanced degree (MS or PhD) preferred

Tools

HPLC

UHPLC

Job description

GlaxoSmithKline seeks a senior analytical scientist to lead a small team delivering method development, validation, and lifecycle management across multiple projects in drug development. You will partner with internal teams and external labs to design studies for product characterization and transfer methods for GMP testing.

The role emphasizes regulatory submission support, scientific documentation, and mentorship to advance career growth while driving high-impact solutions for patients.