Profile

In pharmaceutical manufacturing, product knowledge is not only important but expected. I work for Genzyme, A Sanofi company and work to supply patientst with rare diseases. The main product I work on is for Gaucher’s disease. This is a genetic condition with less than 10,000 confirmed patients worldwide. My role is to ensure that the knowledge we gain about the active pharmaceutical ingredient is built into how if is synthesised, formulated into a pharmaceutical dosage and packaged before being released to the patient.

This is especially important when manufactuirng medicines for rare diseases. The medicines might not be manufactured very often as the numbers of patients they are made for are very small. Therefore it’s critical that the history of product knowledge is well maintained and also that the instructions for manufacture are clear on the critical points for patient safety.

I am based in Waterford, where the product I work on is formulated and filled into capsules then packaged for market release. I work on documents that describe the manufacturing process for API and capsules in great detail and justify why certain process parameters are critical for product quality and why we need specifications to test and release at critical stages in the process.

The active pharmaceutical ingredient is manufactured in Switzerland, which means I need to travel over to visit that site a few times throughout the year. it can take a few months to manufacture one batch of API as it needs to go through multiple synthesis steps. The Quality Assurance people within Genzyme who check the active ingredient is ok to be released to Wateford are based in the USA, so i’m usually on the phone to some of them in the afternoon.

I’m part of a small but focused crew and I like the diverse nature of my job!