Senior Analytical Scientist - Drug Development & Validation

BlackHealth; Collegeville (PA); On-site; USD 100,000 - 140,000; Full time

Job summary

GSK in Collegeville, PA is seeking a Senior Scientist in the Analytical Development department. You will design and perform experiments to develop, validate and transfer analytical methods for drug substance and drug products, contributing to multiple development stages and regulatory discussions.

You will document work per GxP, review experiments and protocols, and provide scientific input to project teams on analytical control strategies, enabling informed decisions and timely progress.

Qualifications

• BS in Chemistry, or related scientific field with 5+ years of relevant experience, or MS in Chemistry, or PhD with no industry experience.
• Experience with method development & validation, pharmacopeia compliance and analytical lifecycle management.
• Technical expertise with several analytical techniques and lab 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 problems in execution of experimental processes; interprets results and communicates them to supervisor.
• Provides scientific input and recommendations to project teams for analytical control strategies and influence decision making.

Skills

Analytical Chemistry

Analytical Instrumentation

Analytical Lab

Analytical Thinking

Bioprocessing

Data Analysis

ELN

GC

HPLC

UPLC

UV/Vis

Method Development

Spectroscopy

Lab Equipment

Education

BS in Chemistry

MS in Chemistry

PhD with no industry experience

Tools

Waters Empower CDS

ELN

Job description

GSK in Collegeville, PA is seeking a Senior Scientist in the Analytical Development department. You will design and perform experiments to develop, validate and transfer analytical methods for drug substance and drug products, contributing to multiple development stages and regulatory discussions.

You will document work per GxP, review experiments and protocols, and provide scientific input to project teams on analytical control strategies, enabling informed decisions and timely progress.