Senior Analytical Scientist, Drug Development & Validation

GlaxoSmithKline plc; Upper Providence (Delaware County); On-site; USD 120,000 - 180,000; Full time

Job summary

GlaxoSmithKline plc is seeking a Senior Scientist in the Analytical Development department to design and perform experiments, develop and validate analytical methods, and support transfer across stages of pharmaceutical development.

The role involves engaging with project teams, ensuring GxP compliance, and contributing to regulatory submissions and internal reports while collaborating with cross-functional groups in a matrix environment.

Qualifications

• BS in Chemistry or related field with 5+ years of relevant experience.
• MS in Chemistry or related field with 3+ years of relevant experience.
• PhD with no industry experience.
• Experience with method development and validation, pharmacopeia compliance and analytical lifecycle management.
• Technical expertise with several analytical techniques and laboratory procedures.
• Experience interpreting and communicating experimental data.

Responsibilities

• Develop and perform assays that support development, release and stability testing of pharmaceutical drug substance and drug products.
• Documents laboratory work in accordance with GxP expectations, company policy, and legal requirements.
• Review of experiments, stability protocols and other key documentation.
• Contribute to sections of patents or regulatory submissions as well as internal reports.
• Identifies and troubleshoots any problems in the execution of experimental processes; interprets results and communicates them to his/her supervisor.
• Provides scientific input and recommendations to the project team for analytical control strategies and influence decision making.

Skills

Analytical Chemistry

Data Analysis

Regulatory Documentation

Communication

Problem-Solving

Education

BS in Chemistry

MS in Chemistry

PhD (no industry experience)

Tools

HPLC

UPLC

GC

UV/Vis

KF

MS

Waters Empower CDS

Electronic Lab Notebook (ELN)

Job description

GlaxoSmithKline plc is seeking a Senior Scientist in the Analytical Development department to design and perform experiments, develop and validate analytical methods, and support transfer across stages of pharmaceutical development.

The role involves engaging with project teams, ensuring GxP compliance, and contributing to regulatory submissions and internal reports while collaborating with cross-functional groups in a matrix environment.