Senior Analytical Scientist: Lead Assay Development & Validation

GSK; Collegeville (PA); On-site; USD 110,000 - 170,000; Full time

Job summary

GSK in Collegeville, PA seeks a Senior Scientist in Analytical Development to design, validate, and transfer analytical methods for drug substance and drug products. You will collaborate with project teams across development stages to establish robust analytical strategies.

You will lead assay development, ensure GxP-compliant documentation, review protocols and data, and contribute to regulatory filings. Strong knowledge of HPLC/UPLC, spectroscopy, and data analytics is essential.

Qualifications

• BS in Chemistry or related field with 5+ years of experience; MS with 3+ years; 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 drug substance and drug products.
• Document laboratory work in accordance with GxP expectations, company policy, and legal requirements.
• Review experiments, stability protocols and other key documentation.
• Contribute to patents or regulatory submissions and internal reports.
• Identify and troubleshoot problems in experimental processes; interpret results and communicate to supervisor.
• Provide scientific input and recommendations to the project team for analytical control strategies and influence decision making.

Skills

Analytical Chemistry

Analytical Instrumentation

Data Analysis Tools

Laboratory Methods

Communication Skills

Education

Bachelor's in Chemistry

Master's in Chemistry

PhD in Chemistry

Tools

HPLC

UPLC

Waters Empower

Electronic Lab Notebook

GxP Knowledge

Job description

GSK in Collegeville, PA seeks a Senior Scientist in Analytical Development to design, validate, and transfer analytical methods for drug substance and drug products. You will collaborate with project teams across development stages to establish robust analytical strategies.

You will lead assay development, ensure GxP-compliant documentation, review protocols and data, and contribute to regulatory filings. Strong knowledge of HPLC/UPLC, spectroscopy, and data analytics is essential.