Title:  Executive - Analytical Development

List of Responsibilities / Job function:

• Responsible to perform analytical method development and partial validation of finished pharmaceutical injectable formulations.

• Responsible to work on plant trouble shooting and FDA query related activities as and when required.

• Responsible to performing calibration of the instruments like HPLC, pH meter and balance.

• Provide training to junior or new team members on laboratory techniques.

• Responsible for Invitro release study and multimedia dissolution of the various pharmaceutical formulations using dissolution apparatus like Type-I, Type-II, Type-IV, Franz diffusion and Bottle rotating apparatus.

• Discussion with cross functional teams for the continuous improvements in the process and methodology of the injectable formulations.

• Actively involved in the method transfer activities at CAL and plant locations.

• Responsible to perform routine stability testing of the pharmaceutical finished products. Conducting the degradation studies to provide stability indicating method for the finished pharmaceutical formulations

• Responsible to analyse and interpret the experimental data and ensures their reliability and accuracy.

• Responsible for preparation of AQbD reports by analyzing and summarizing the data statistically, drawing the logical conclusions and recommendation of the further course of action.

• Responsible to perform stability testing of the various pharmaceutical formulations to ensures the shelf life of the products.

• Responsible to maintain instrument/equipment as per SOPs.

• Responsible to follow safety precaution as per laboratory procedure

List of Competencies Required:

Technical Competencies

• Master of science

• Good knowledge of MS Office (Word, excel, power point etc)

• Sound knowledge of various sophisticated analytical techniques.

• Problem solving skills to identify and resolve the issues related to pharmaceutical formulations.

• Capability to develop and analyze pharmaceutical formulations.

• Proficiency to use instruments like HPLC, Auto-titrator etc.

Behavioral Competencies / Soft Skills:

• Ability to work as a team collaboratively in the lab and contribute to positive work environment.

• Ability to communicate effectively with peers and higher authorities, both in written as well as verbal way.

• Ability to think and evaluate the experimental results and draw meaningful conclusions.