A Black Diamond Client in Pennsylvania is looking for an analytical CMC consultant who can provide part-time consulting coverage for six months. Our client is preparing for an NDA submission for a combination medical device. The product is administered with a single-use applicator that includes a filter, tip, and cap.
The consultant will be primarily concerned with the analytical reports and documents needed for CMC module three of our client's NDA submission. Taking direction from the analytical chemistry lead, the consultant will lead and assist in assembling module three documents. The consultant's responsibilities will include assembling tables, table collections, and some of the actual writing of section three. Candidates for this position should have at least five years of relevant experience with a strong background in working with small molecules.