Friday, December 20, 2013 9:17:57 AM
Oversight of greater than 6 clients release and stability testing services. Successfully expanding QC service offerings to include client method development, protein characterization services and expanded in-house raw materials QC testing. Actively look for and engage potential new clients with Business Development group to grow business. Modernized the QC laboratories with equipment upgrades as well as implementation of paperless laboratory.
•Lead team of 18 for raw materials, lot release and stability testing for several high profile clients
•Team member involved in providing input into ‘Request for Information’ and ‘Request for Proposal’ for prospective clients.
•Member of the Leadership Board for business governance to increase profitability of Avid Bioservices
•Sponsor six sigma, lean manufacturing and continuous improvement efforts to streamline daily operations in QC
•Participate in Peregrine Pharmaceuticals CMC team as a consultant/individual contributor for lead Phase III candidate
•Overhaul QC Stability program: SOP Improvement; OOS and OOT procedures to include relevant statistical analysis criteria and outlier detection, Stability SOP to reflect current ICH guidelines, increase internal capability by expanding 'submission ready' stability reports for clients as well as increase storage solutions meeting all four world climactic zones for solid dose formulations
http://www.linkedin.com/pub/michael-molony/5/7a8/bb5
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Info re: Paperless Laboratory
http://www.scientificcomputing.com/articles/2004/10/designing-paperless-laboratory#.UrRSFOKO7Kc
"Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that is the cornerstone of a broad clinical
pipeline." -- Big Pharmas nightmare... unless they are fortunate enough to have The Bavi Edge!
