Senior Research Scientist - R&D BDL

Job Summary:

This position requires both scientific and supervisory inputs. In this role, the person will lead a team that is involved in development, qualification, transfer and validation of different types of characterization and lot release assays (cell-based assays, ELISA, process related impurity assays, SPR based assays) to support the commercialization of biosimilar products.

Key Responsibilities:

1. Manage a team of 4-6 Scientists [includes goal setting, understanding developmental needs, assigning responsibilities in the laboratory activities, critically assessing their performance, and providing timely feedback].

2. Accountable for planning and execution of method development & qualification as per project requirements and as per regulatory guidelines.

3. Accountable for planning and execution for sample analysis for multiple studies.

4. Technical data review, compilation, trending.

5. Data communication to cross functional stakeholders and presentation in project review meetings.

6. Review of SOPs, protocols, laboratory notebooks, raw data and study reports for all team activities.

7. Ensuring materials and reagent availability as well as equipment functionality.