Mindy Wan Email & Phone Number

Durham, North Carolina, Us

Sustainably advancing drug development through scientific excellence.

Built and led a team of 17 biotech professionals in support of cGMP operations, tech transfer, regulatory filing and inspections as well as biological manufacturing facility design and start-up. The most significant parts of this responsibility were leading the effort for Synagis® commercial process improvements by developing and implementing benzonase free process yielding a production saving of $300,000/per batch and leading the effort for Knowledge Management in supporting of tech transfer, regulatory filing and inspection readiness for the Site.

Abbott Park, Illinois, Us

Led the effort on MS&T team building, Humira® 2nd generation process development and implementation, Abbott Puerto Rico biological manufacturing facility start-up and approval support. Managed team in supporting biopharmaceutical tech transfer, cGMP operations and new technology introduction. Led the in-process assays development and in-process monitoring analytical activities for process understanding. Successfully led the effort for Humira® process specific HCP assay reagent development and implementation. Served as CMC Subject Matter Expert (SME) for biological drugs worldwide regulatory filings and inspections.

Led the project teams on client processes developing and transferring to meet clinical cGMP manufacturing requirements, managed client communications and delivery of clinical trial materials per contract agreements. Served as a Subject Matter Expert (SME) for purification process development on recombinant therapeutic proteins expressed from E.coli, mammalian cells and insect cells with hands-on scale up and manufacturing experience for clinical trial cGMP materials production. Established an E. Coli host cell proteins (HCPs) assay for in-process controls. Developed a proteases screening methodology for monitoring recombinant protein recovery processes.

Us

Led the effort transferring projects from research lab to process development, characterization of protein products and variants. Downstream purification process development and scale up for clinical production. Hands-on experience of process characterization in scale-up/scale-down models and in a pilot scale under cGMP conditions. Managed the recovery/purification process in manufacturing of large quantities of therapeutic antibody (kilogram scale) for clinical trials. Supported biologics manufacturing facility IQ, OQ and PQ activities.

Singapore, Sg