- 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.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- 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.
- Experience working with several analytical techniques, and laboratory procedures.
- Experience in interpreting and communicate experimental data.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Knowledge of cGMP requirements
- Experience with analytical support of challenging long acting injectable, parenteral and sterile formulations.
- Experience with analysis of active pharmaceutical ingredients (API) and their process 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, dissolution, UV/Vis spectrophotometry, KF, MS, and laboratory procedures.
- Good technical writing skills for documentation. Experience in regulatory documentation authoring.
- Ability to collaborate and communicate well with others in and across groups in matrix.
- Thorough operational knowledge of laboratory equipment and laboratory systems (e.g. Waters Empower CDS and Electronic Notebook system).
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.