Biopharmaceutical company charting new frontiers in drug delivery.Core business strategy is to develop oral forms of injectable drugs by applying proprietary eligen® technology to drugs. Has built strategic alliances with world-leading pharmaceutical companies
Senior Vice President, Operations; Office of the President2001 to present In charge of Finance & Accounting; Information Technologies; Vivarium Operations; Corporate Design and Creative Services; Facilities; Safety; Purchasing; Project Management; Regulatory Affairs; Quality; Manufacturing; Chemistry; Drug Development.Serve on executive leadership teams – Chair Contract and Disclosure Controls & Procedures Committees; member, Promotion Review and Rewards/Recognition Committees; member, Financial Review Team for 401k Plan and Benefits.Designated Institutional Officer - oversee animal research and Institutional Animal Care and Use Committee (IACUC).Staff: 50+; report to Chief Executive Officer.
- CEO for acquired FarmTech subsidiary, overseeing day-to-day operations of Farmington, CT site - revamped infrastructure through change initiatives regarding human capital, processes, and operations, i.e., staffing; purchasing; rehabilitation of laboratory operations; budgeting; systems, and processes, updating SOPs, and computer systems.Signatory on regulatory permits, interface with parent.
- Created synergies through the development of close working relationship between Emisphere and FarmTech science staff allowing data produced to be more meaningful which fostered faster development of technology.Established capabilities for handling GLP stability, Non-Human Primate (NHP), rabbit, and rodent studies, Radio Chemistry lab, and bioanalytical and chromatographic assays.Laid groundwork for GLP Toxicology work.
- After Emisphere’s focus changed, sold FarmTech facility recouping original cost and capital improvements invested - identified and supervised real estate broker; worked with local government officials and company attorneys on zoning and environmental concerns; negotiated final price directly with buyer; managed outside attorneys to finalize all paperwork and close transaction.
- Instituted massive cost control programs including upgrade of financial systems to Oracle Financials and establishment of peer review process for all large expenditures through the Contract Committee.
- Collaborated with CFO to form and manage Sarbanes-Oxley (Sarbox) implementation team; sourced and managed outside Sarbox consultant; led Information Technology compliance effort, identified IT controls; worked with auditors through testing process; served as Chair of Disclosure Controls and Procedures Committee
- Passed Sarbox compliance audit with no significant observations, a critical requirement to operate as a public company and continue to raise money in the public markets.Significant cost savings achieved by handling bulk of IT compliance internally.
Vice President, Operations1998 to 2001
Managed Finance & Accounting; Information Technologies; Corporate Design and Creative Services; Facilities; Safety; Purchasing; Regulatory Affairs.Served on executive leadership teams – Chair Contract; member, Promotion Review and Rewards/Recognition Committees; member, Financial Review Team for 401k Plan and Benefits.Staff: 20+; reported to Chief Executive Officer.
- Rescued stalled $35MM, three-year international, multi-center phase III trial - 2,200 patients at 125+ sites in 10 countries.Led all operations - established clear responsibilities with internal and external teams; identified bottlenecks and instituted changes to streamline workflow and simplify execution of trial while maintaining quality and integrity of data; contracted with additional Contract Research Organizations to expand countries and sites resulting in increased enrollment rates; negotiated contracts and budgets with outside vendors; point of contact with outside scientific advisors allowing them to give valuable support and input to the progress of the trial.
- Led $30MM construction project for 120,000 square feet of mixed laboratory and office space - formed internal team to identify user requirements; negotiated with landlord to identify and lease required space; contracted with vendors (architect, engineer, general contractor, etc.); oversaw design and construction offacility; formed and managed validation team, allowing space to be used for FDA approved GMP manufacturing.