Senior Analytical Scientist – GSK, Upper Providence (PA), USA

Job Description

As a Senior Scientist in the Analytical Development department, you will design and perform experiments to develop, validate and transfer various analytical methods. You will be involved in all aspects of pharmaceutical development, including engagement with project teams and other stakeholders for projects in different stages of development.

Key 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.

Qualifications

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

Skills Required

• Knowledge of cGMP requirements
• Experience with analytical support of small molecule API and ADC drug linker intermediate development.
• Awareness with FDA/EU/UK and ICH regulations and guidances related to analytical transfer and validation and release and stability testing.
• Working knowledge and experience in small molecule analytical techniques such as HPLC, UPLC, GC, UV/Vis spectrophotometry, KF, MS, and laboratory procedures.
• Experience working with CRO's/CDMO's.
• Good technical writing skills for documentation and experience in regulatory documentation authoring.
• Ability to collaborate and communicate well with others in and across groups in a matrix environment.
• Thorough operational knowledge of laboratory equipment and laboratory systems (e.g. Waters Empower CDS and Electronic Notebook system).
• Data Analytics Skills: SQL, PowerBI, Spotfire

Additional Information

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