Description
As a Senior Scientist in the Analytical Development department at GSK, 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.
Responsibilities:
- Develop and perform assays that support development, release, and stability testing of pharmaceutical 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 sections of patents or regulatory submissions as well as internal reports.
- Identify and troubleshoot problems in the execution of experimental processes; interpret results and communicate them to your supervisor.
- Provide scientific input and recommendations to the project team for analytical control strategies and influence decision-making.
Basic 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 and 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.
Preferred Qualifications:
- Knowledge of cGMP requirements.
- Experience with analytical support of small molecule API and ADC drug linker intermediate development.
- Awareness of 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 CROs/CDMOs.
- 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.
- Data Analytics Skills: SQL, PowerBI, Spotfire