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Locations:
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2015
- Conduct due diligence activities to obtain and analyze pertinent information relative to potential investment company’s management, market, technology, products, competitive landscape, financial history and projections, business strategy and plan, and making recommendations on the technology or a company’s commercialization potential - Provide comprehensive evaluation and risk analysis of investment opportunities through completion of the due diligence process - Prepare written analysis of company’s business plan and strategy, intellectual property, and product - Syndicate with other venture investors - Prepare funding recommendations to the General Partner and close on approved investments accordingly - Participate as board observer at portfolio company board meetings - Manage a portfolio of investments and track metrics and attainment of milestones - Identify and source venture opportunities
2012 - 2015
2014 - 2015
Responsible for high level project management activities for the commercialization of two pipeline drugs totaling more than $150MM. PM for high priority project of collection/analysis of critical issues pertaining to the commercial process, assigning project leads, and ensuring follow-through and close-out of critical activities. Project lead for resolution of over 450 issues ranging from document revisions, operational procedural changes, computer systems changes, and engineering solutions. Disciplined adherence to these tight timelines, communication with cross-functional teams, and resolution of complex issues were of upmost importance to ensure that these drug products stayed within company timelines for FDA submission/licensure Assisted in implementing the upstream production of a pipeline drug which included the coordination of documentation and operational training as well as ensured the qualification and stock of raw materials/disposables. Authored the system change control to provide the definition of engineering runs to allow for facility/production cleaning and the production area release. Assisted in a successful Pre-Approval regulatory agency inspection.
2013 - 2014
Raw Materials SME/Disposables Lead: Performed clinical to commercial raw material transition for new pipeline therapy. Ensured required corrective actions for discrepancies that would have resulted in raw material availability shortages impacting process validation run schedules were completed. Facilitated a team consisting of Global Supply Chain, Global Biological Development, Procurement, QC, QA, Manufacturing Sciences, and Validation to qualify vendors, validate assays, perform materials clearance, revise documentation, and perform risk assessments. Coordinated and assisted resolution of discrepancies and corrective actions required for the Purification Area release and start of Purification Runs. This was a key role in ensuring that the timeline for the new product project stayed within expectations and to minimize impact to the start of engineering runs for a hematology drug. Promoted to API Projects Interface Specialist role (Project Manager)
2012 - 2013
Conducted investigations on Fermentation and Isolation discrepancies to adhere to GMP requirements and prepare for Conformance Runs. Adhered to strict production schedules by closing discrepancy investigations on time and proposed corrective actions.
2012 - 2012
Performed production scale membrane adsorption chromatography to support a pipeline treatment. Maintained and organized process timelines and schedules for the development of future commercial process scheduling, maintained the health of six production scale bioreactors for the duration of production campaigns
2012 - 2012
Executed the tech transfer of a membrane adsorption chromatography step from the research organization lab to the Manufacturing Sciences Purification small scale lab. Enables characterization of fermentation small scale studies and processing of fermenter harvest for analytical testing. Organized a membrane adsorber improvement project that would dramatically increase cycle time and improve yield. Performed a correlation study between a QC analytical potency assay and stand-alone robotic potency assay machine. Studied the correlation between the current QC potency assay for Kogenate-FS purification process products and intermediates. Allows for the use of the stand-alone potency analyzer as a faster screening method for purification development studies thus enhancing the efficiency of development studies. Reduces the sample load submitted to QC as part non-routine testing.
2011 - 2011
2011 - 2011
Developed a resin slurry determination method to be used for large-scale chromatography column packing. Study originally proposed to be completed by a team of PhD chemists in Germany at a cost of $60,000. Completed the study in 3 weeks. Optimized and implemented a production-scale vibrational/flow-packing method for column packing, which ensures robust repeatable packing of controlled pore glass beads. This saves an average of 15 hours of 3 FTE’s each pack due to lack of failures.
2009 - 2009
2009 - 2009
Performed laboratory work to support multiple projects. Trained in BCA protein assays, rat simulated surgeries and dissections, sub-cultivation/freezing/thawing of vascular smooth muscle cells, created gel buffers, and Western Blots by electrophoresis.