In this role you are required to solve routine problems, largely through precedent and referral to general guidelines. Your expected interactions are within your own team and direct supervisor.
This is a key hands-on, non-supervisory position. In this role, the Scientist initiates and executes stability studies for reference standards using appropriate compendial methods. Additionally, the incumbent will be responsible for performing analytical method development and validations for Impurity RS and maintaining safety and GLP environment in the lab.
Must have excellent skills and knowledge of bioanalytical sample processing techniques. Very good understanding of current bioanalytical guidelines of various regulatory agencies such as USFDA, ANVISA, ICH etc.
Ensures that justified extension requests are made before the investigation deadline and that the investigations and CAPAs are closed within the required timeframe. Acts as a guardian of metrics by carrying out periodic follow-ups regarding investigations and CAPAs opened with internal and external partners.
Operational Excellence - Build on technical expertise, expanding it in complementary directions. Use technical expertise and creativity to proactively identify potential problems and address them using appropriate resources in discussion with team leads.