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