Senior Analytical Scientist

GSK•Upper Providence, PA

About The Position

As a Senior Scientist in GSK’s Analytical Development department, you will design and perform experiments to develop, validate, and transfer analytical methods. You will contribute to pharmaceutical development at multiple stages and engage with project teams and other stakeholders. The work supports development, release, and stability testing of pharmaceutical drug substances and drug products, and includes providing scientific input on analytical control strategies.

Requirements

Bachelor’s degree in Chemistry or a related scientific field with at least 5 years of relevant experience; or a master’s degree in Chemistry or a related scientific field with at least 3 years of relevant experience; or a PhD with no industry experience.
Experience with method development and validation, pharmacopeia compliance, and analytical lifecycle management.
Technical expertise and working familiarity with several analytical techniques and laboratory procedures.
Experience interpreting and communicating experimental data.

Nice To Haves

Knowledge of cGMP requirements.
Experience supporting development of small-molecule API and ADC drug-linker intermediates through analytical work.
Awareness of FDA, EU, UK, and ICH regulations and guidance related to analytical transfer and validation, and release and stability testing.
Working knowledge and experience with small-molecule analytical techniques such as HPLC, UPLC, GC, UV/Vis spectrophotometry, KF, and MS, as well as laboratory procedures.
Experience working with CROs or CDMOs.
Good technical writing skills, including documentation and regulatory-document authoring experience.
Ability to collaborate and communicate effectively with others within and across groups in a matrix environment.
Thorough operational knowledge of laboratory equipment and systems, such as Waters Empower CDS and electronic notebook systems.
Data analytics skills, including SQL, PowerBI, or Spotfire.

Responsibilities

Develop and perform assays that support development, release, and stability testing of pharmaceutical drug substances 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 sections of patents or regulatory submissions, as well as internal reports.
Identify and troubleshoot problems in experimental processes, interpret results, and communicate them to a supervisor.
Provide scientific input and recommendations to project teams on analytical control strategies and influence decision-making.