Greater Boston
Operations Leader with extensive experience in Biotechnology and Pharmaceutical organizations. Diverse production and supply chain expertise supporting both clinical and commercial operations including the manufacture of monoclonal antibodies, autologous cell-based cancer therapies and vaccines, tissue engineered devices, and parenteral products with production volumes ranging from hundreds of units to 55 Million units annually. Hands-on leader with demonstrated ability to develop and execute operational and quality-based programs to drive continuous improvement, support key business strategies, and deliver results. Key skills/strengths include; •Manufacturing & Production Management •Lean Manufacturing / Continuous Improvement •Contract Manufacturing •Aseptic Manufacturing •Supply Chain / Cold Chain Management •cGMP Cell Banking (CHO, human cell lines, hybridoma cell lines) / Cell Culture •Monoclonal Antibody production / Bulk Drug Substance •Budget Responsibility - Capital/Manufacturing Costs •Project and Program Management •Strong technical and analytical skills •Team building and employee development •Leading Technical Services organizations •Managed compliance and met all government regulations for multiple FDA general inspections •Leading through change
Responsible for ensuring on-time supply of all Clinical Supplies including all activities and personnel in the Clinical Supplies function as well as managing necessary vendors. Provide leadership and expertise for designing and implementing Clinical Supplies strategy for Shire R&D. Liaise with Strategic Sourcing for vendor management and with interdepartmental management to assist in establishing R&D policies and ensure that activities are in line with company goals, expectations, and all applicable regulations.
Provide functional and strategic leadership to the Business, Process, and Integration team within the Global Clinical Supply organization. • Overseeing the integration of two legacy Clinical Supplies teams (Rare Disease and Specialty Pharmaceuticals) into a harmonized Clinical Supply Operating Model • Manage all Clinical supply integration activities related to new products and acquisitions including process alignment, system integrations, and people. • Direct Clinical Supply system integration (i.e.PMD/ClinApps, SAP, IRT) with key external vendors and internal stakeholders, as the business process owner. Provide leadership regarding managing upgrades, enhancement projects, change control, and training related to the Clinical Supply systems (ClinApps).
Led the development and execution of global supply strategies supporting all biologic programs including vendor management, labeling, packaging, and distribution of IMP, ancillary components, and devices. • Oversaw the management and delivery of clinical supplies globally for 15 programs, over 30 protocols (Phase I-IV), and Investigator sponsored trials. • Developed standardized lead times and implemented metrics to monitor performance of Clinical Supply chain. • Reduced lead time for label generation by 25%.
Accountable for the performance of the end-to-end product supply chains for AstraZeneca and Third Party Parenteral products including overall customer satisfaction. Managed a team of 10 direct reports and a total headcount of 108. Defined strategic and tactical direction for the Process Execution Team, ensuring alignment to high-level Site and Product Supply business objectives. Implemented strategic goals for the supply chains focusing on quality, on-time delivery, lead-time reduction, and safety through Lean implementation. • Produced 82 NDC’s on three aseptic filling lines and five packaging lines. • Implemented and embedded Lean manufacturing principles and work processes. • Hired, mentored, and coached a team to drive continuous improvement and process excellence resulting in a 50% improvement in customer service, 15% increase in capability, 20% reduction in cycle times, and a 73% reduction in deviations. • Transitioned a three-shift operation to a two-shift operation. • Reduced changeovers by 50%. • Member of the Site Leadership Team sharing the responsibility for developing and delivering the site budget, objectives, and strategies.
Directed the Site Technical Services department including Manufacturing, Packaging, and Validation Technical Services. Accountable for new product introductions (NPI), labeling changes, line extensions, technology transfer, and technical support throughout the product lifecycle. •Spearheaded and implemented a business development strategy that successfully managed technical projects for contract manufacturing customers. Created additional revenue for the site, up to $1M annually. •Reorganized manufacturing site of 700+ employees as a member of the site leadership team and implemented Lean Manufacturing. •Facilitated delivery of “Lean Experience” training to all site employees. •Leader in organizational design process for Technical Change Management implemented company-wide supporting US Operations. •Directed a global cross-functional team that prepared and successfully filed a submission for specification relief for a key product resulting in improved process controls and cost reductions. •Led a labeling project for a new product launch that resulted in significant cost reductions and annual savings of $500K.
Accountable for the Phase III clinical production and distribution of an autologous cancer vaccine for non-Hodgkin’s Lymphoma. Managed six direct reports responsible for vaccine production (cell banks, cell culture, hollow fiber bioreactor production, purification), materials management, and purchasing. •Directed multiple cross-functional project teams to oversee and manage the vaccine program. •Expanded clinical trial globally with the initiation of clinical sites in Russia and Ukraine. •Trained CRO’s on vaccine production, logistics associated with biopsy and vaccine shipments (Cold Chain Management), scheduling, processing patient samples for clinical assays, and supply requirements. •Primary liaison with CRO’s, clinical sites, and third parties to manage the coordination and supply of vaccines to clinical sites including scheduling patient surgeries, vaccine delivery, and logistics.
Provided leadership and direction for cGMP contract manufacturing operations for monoclonal antibodies and autologous vaccines. Managed eight direct reports with responsibilities for vaccine production, cell culture, cell bank production (CHO, hybridoma cell lines), antibody production (hollow fiber bioreactor), bulk drug substance, purification, final fill, facilities, calibration, validation, materials management, and purchasing. Acted as the project manager for the vaccine commercialization program. Represented the company as a prime internal and customer contact on contracts and operations. Performed project management functions to ensure project requirements were fulfilled and timelines were achieved. Supported Sales and marketing by developing and writing proposals for new projects. •Managed all third party relationships supporting vaccine production including contract manufacturing organizations and the National Cancer Institute. •Led the consolidation and technology transfer of all vaccine production activities from three different locations to the Worcester facility and transferred all contract manufacturing operations to the Minneapolis facility. •Developed standard costs for manufacturing procedures and quality control assays to establish accurate pricing for contract services. •Directed two facility renovations to increase production capacity and to support production activities for a phase III autologous cancer vaccine. •Significantly reduced product loss through the implementation of remote access to bioreactors to ensure continuous monitoring of the systems and immediate response to alarm conditions. •Instituted the use of quality metrics to trend equipment failures, contamination rates, batch record review, environmental monitoring results, and deviation reports to identify and implement measures to reduce overall costs. Reduced product contamination rate from 50% to less than 10%.