Analytical Scientist III

Job Summary:

Laboratory position which involves development and validation of analytical methodology in support to the research projects involving testing of pharmaceutical components and/or drug products. This position also involves designing and completion experiments and providing scientifically sound recommendations based on the data obtained.

Job Responsabilities

- Developing new analytical methods using innovative solutions for actives, excipients, drug release, residual solvents and to support product development.

- Validating analytical methodologies following ICH guidance

- Executing complex experiments in support to R&D for development and validation of process under minimum supervision.

- Ability to identify creative and innovative solutions of non routine analytical tasks

- Improves analytical applications by implementing new analytical techniques

- Clearly interpret problems, make scientific judgment based on outcome of the obtained data and take appropriate actions to resolve the issues.

- Writing/reviewing protocols, reports, SOP’s, specifications & test procedures.

- Compiling necessary documentation to support regulatory submissions such as Abbreviated New Drug Applications (ANDAs) or New Drug Applications (NDA), as required.

- Adhering to laboratory SOP guidelines, GMP requirements and safety rules.

- Maintaining analytical instrumentation through the proper performance and/or maintenance as required.

- Train junior scientists and QC chemists as necessary.

- Demonstration ability of problem solving and offer necessary recommendations.

- Works as a member of a team to achieve all outcomes

- Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.

- Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion

- All other relevant duties as assigned