Rubicon Research - Manager - Extractable & Leachable Studies - Pharmaceuticals Sector

Role deliverables:-

- Ensure timely completion of development, validations for extractables and Leachable studies.

- Literature search of relevant projects

- Preparation and review of protocols for verifications, validations, and related activities

- Providing technical inputs to the team to develop analytical methods

- Review of E&L protocols.

- Defining strategies for E&L studies by LC-MS, GC-MS, ICP-MS

- On job training to subordinates on extractables and leachables

- Prepare and review various documents such as development reports,

- Ensure GLP compliance in the laboratory

- Monitoring the trend of stability results for the stability batches for potential Leachables

- Performance of method development, validations and other analysis as required.

- To ensure timely completion of all spectrophotometric analysis for development, validation, regulatory submissions.

Ideal profile :

1. 8-14 years of experience in Pharmaceuticals Industry.

Key behavioral / personality Traits:

1. Problem solving

2. Collaboration

3. Process driven

4. Adaptable

5. Ambitious & Driven