Scientist-IV

The Senior Scientist will perform complex testing in compliance with laboratory test methods and procedures to support the manufacturing and timely delivery of product to customers (75 to 100%). The Senior Scientist will receive general instructions about required tasks and results expected. Work will be well defined and will be reviewed for accuracy upon completion. The Senior Scientist is expected to apply standard practices and techniques in specific situations and to recognize discrepancies in results and follow operations through a series of detailed steps and processes. The Senior Scientist should be able to serve as an expert in technical areas (15-25%). Additionally, the Senior Scientist has accountability and ownership to maintain laboratory instruments in their qualified state as well as troubleshoot instrumentation in the event of instrument issues.

ESSENTIAL FUNCTIONS:

Major responsibilities will include:

1. Operating in accordance with current GMPs. This includes the ability to understand and apply SOPs and use GMPs for documenting, testing and maintaining accurate laboratory records.

2. Performing increasingly complex testing to support product release

3. Supporting product development, validation and test method transfer activities

4. Initiation and investigation of non-conforming laboratory test results as well as the communication of stability and quality issues to the next level of management

5. Providing initial and final review of data generated by peers and contract laboratories

6. Performing daily calibrations/verifications and routine maintenance of laboratory instrumentation and equipment according to current SOPs.

7. Support the Instrument Lifecycle Management Process

8. Support the Software Lifecycle Management Process

9. Assisting in various other duties which contribute to the organization and function of the laboratory.

10. Responsibility for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.

11. Maintain up to date knowledge on the latest applicable laboratory techniques, advances and technology.

12. Performing other related duties as assigned by management.

Best Regards,

Sneha Shrivastava

973-967-3348