I have worked over 34 years in the pharmaceutical industry. First as a synthetic organic scale-up chemist at Burroughs Welcome and Glaxo Welcome for 13 years, then I joined Glaxo Welcome Clinical Supply Operations team in 1998. I have managed clinical supplies from small start-up to large pharmaceutical companies and at a large CRO. Currently I am working for Biogen in the Global Clinical Operations team as their “Manager, Clinical oversight of Supplies” advising on issues with Non-IMP, equipment and ancillary supplies being used in their clinical trials.
My experience covers ambient, room temperature, and cold chain shipping; sourcing equipment, ancillaries, comparators, co-meds & rescue meds; labels and translations; directly working with vendors, regulatory submission groups, QA groups, and import/export teams.