Responsibilities will include (but not limited to):
- Performing release testing for biological products
- Assisting in updating and issuing documentation, including SOPs, as required.
- Performing routine data analysis, assist in the investigation of OOS results, perform trending analysis and writing investigation reports.
- Accurately documenting laboratory work.
- Execute and assist in technical transfer and co-validation activities.
- Assisting with qualification of laboratory instruments.
- Data review based on demonstrated proficiency on assays.
Qualifications and Experience required:
- 1-2 years’ experience in a regulated biopharmaceutical laboratory is essential. HPLC/UPLC and Empower experience is required.
- The ideal candidate should hold a minimum of a BSc. in Biochemistry or related discipline.
- The successful candidate must demonstrate an ability to work independently in assay and recognize anomalous trends or results.
- Must demonstrate problem solving ability, as well as the ability to prioritize objectives from multiple projects and adhere to scheduled timelines. Excellent communication and the ability to work in a team based collaborative environment are required.