Manage team of Operations Leads in support of on time and in full delivery of products supplied by contract manufacturing organizations (CMOs)/external suppliers within the perimeter of External Manufacturing and Supply (EM&S) Large Molecule, Rare Diseases Oncology and Immunology (RDOI).

Managed drug substance and finished goods manufacturing operations at CMOs, taking responsibility for delivery against the contract. Served as primary Sanofi interface for all communications regarding site manufacturing activities (virtual plant manager) and manage operations to create value in meeting Sanofi’s business objectives.

Lead cross-functional change teams in initiatives to implement Sanofi Manufacturing System (SMS) tools and reduce non-value-added activities (NVA) utilizing lean principles such as 5S. Coach Change Agents and functional area personnel to ensure sustained implementation and cultural change.

Managed large scale fermentation and purification operations for the Bulk Hyaluronic Acid (HA) API production process. Chaired weekly production meetings, and manage staff, facility and other resource requirements to ensure that established goals and priorities are met.

Responsible for managing a staff of up to 23 supervisors and operators in the successful production of clinical and commercial recombinant proteins, and for the successful integration of night shift personnel in mid- to long-term production planning and continuous improvement initiatives.

Overall responsibility for the management of up to 38 process supervisors, operators and suite coordinators in the successful operation of large-scale commercial processes for the purification of recombinant proteins. Actively facilitated process improvement efforts including a plant trial recommendation (PTR) to implement a new purification unit operation.

Supervised protein purification unit operations in Wyeth Biopharma’s multi-product clinical manufacturing facilities during production campaigns for nine clinical candidates. Analyzed key process parameters in support of deviation investigations and project presentations. Participated in cross-functional teams responsible for implementation of new technology and Wyeth Conformance Standards. Managed up to seven direct reports during production and validation support activities.

Coordinated and performed all aspects of the purification of a line of biotechnology products based on recombinant Protein A. Assumed supervisory role for five different production processes consisting of up to five purification steps and employing three manufacturing associates. Process steps included ion exchange and size exclusion chromatography, as well as tangential flow filtration.

Eight years of increasing responsibility as a member of the Superfund Technical Assessment and Response Team (START) providing technical and regulatory support to U.S. EPA personnel.