William Harris, Phd, Pmp Email & Phone Number

Framingham, Ma, Us

Burr Ridge, Il, Us

Led global biologic and small molecule drug development teams and medical device development teams at both small biotech and large pharma clients. Development stages spanning Discovery to Phase 3. Leveraged my technical and leadership experience in process and analytical development to develop aggressive and realistic project plans and drive teams to execute to those plans. Successfully integrated team members from a small biotech and their large pharma owner with divergent cultures and processes. Led an initiative at a small biotech to develop a new project team and governance structure. Managed project budgets and was key member of a team implementing a new budgeting and forecasting system.

Cambridge, Ma, Us

Initiated and managed cross-functional teams responsible for developing program strategy and integrated plans, and executing activities leading to Research-to-Development transition and IND/CTA filing. During tenure, managed five biologic and two small molecule projects to successful, on-time R-to-D transitions.

Initiated business development function at newly-acquired company. Coordinated evaluation of potential in-licensing opportunities in oncology, neurology and infectious disease. Researched and identified opportunities, coordinated scientific evaluation, performed initial market analysis and competitive intelligence, coordinated interactions with target companies. Handled multiple projects simultaneously.

Led group of six scientists developing and scaling up purification processes for Phase 1 clinical manufacture of recombinant protein vaccine candidates. Improved team effectiveness to cut development time. Two projects reached Phase I clinical trials in the time frames of the original project plans.

Directed small group to develop and scale up purification processes and assays for recombinant proteins. Developed purification process and analytical assays for vaccine candidate and implemented technical transfer to partner.

Directed Biochemistry Department, including Protein Characterization, Assay Development and Technical Transfer Groups. Up to eight scientists in department. Key member of ONTAK project team from preclinical development through BLA submission and facility inspection.