Accelerator to Biopharmaceutical DevelopmentChampion for the Advancement of Innovative Technology Platforms Expert in Bioprocess Chemistry, Manufacturing & ControlsAreas of focus include:✓ Chemistry, Manufacturing & Controls (CMC) ✓ CMC Due Diligence for In-licensing and M&A ✓ Contract Development & Manufacturing (CDMO) Oversight ✓ Clinical & Commercial Supply Agreement Negotiation and Arbitration✓ Technology Transfer ✓ Process Validation✓ Regulatory Compliance

Responsible for bioprocess development from early clinical development through commercial life-cycle management spanning cell line, cell culture, purification, analytical, scale-up, technology transfer, process validation, registration and life cycle management for commercial products, R&D pipeline development programs and contract manufacturing client programs at facilities located in Worcester MA, Puerto Rico and Singapore. Leading a team of 150+ world-class BS, MS and PhD level scientists and engineers that has delivered 6 successful new product launches including HUMIRA, SKYRIZI and contract manufacturing client products.

Responsible for the process development and manufacture of biologics drug substance in support of commercial, clinical and contract manufacturing product portfolios. Management responsibilities included oversight of Biologics Production and Engineering at the Worcester, MA facility and Global Process and Manufacturing Sciences with a total of 530 employees across 4 sites located in Worcester, MA, Barceloneta, Puerto Rico, Redwood City, CA and Singapore. Manufacturing portfolio included 3 commercial products, several late stage products in development with partner companies and contract manufacturing clients as well as numerous early phase clinical candidates. Worcester Biologics Production and Engineering was subsequently integrated with AbbVie’s global manufacturing network.

Responsible for the manufacture of biologics drug substance in support of commercial, clinical and contract manufacturing product portfolios. Management responsibilities included oversight of Biologics Production and Engineering Departments with a total of 230 employees including four integrated manufacturing suites equipped with 3,000L and 6,000L bioreactors for mammalian cell culture and downstream operations to bulk fill of drug substance, core support, media/buffer prep, planning, logistics, validation engineering, project engineering, controls engineering, process engineering, GMP utilities, maintenance, site support, near and long term capacity planning and cost center financial management.

Responsibilities included strategic management of the biologics drug substance manufacturing portfolio including commercial, clinical and contract manufacturing. Management responsibilities included 5 direct reports including 2 PhD level Chemistry, Manufacturing and Controls (CMC) Directors and 3 Project Managers with significant matrix leadership responsibility for successful execution of multiple internal clinical development drug substance CMC/manufacturing programs and multiple third party drug substance contract manufacturing programs, support of commercial operations sales and account management for third party work, as well as near and long term capacity planning.

Responsibilities included Protein Sciences, Enzymology, Structural Biology and Kinase Selectivity Screening (KSS) with management responsibility for 22 employees and annual research budget. Protein Sciences designed, cloned, expressed and purified recombinant proteins used in lead discovery, structural biology and kinase selectivity screening applications.

Responsibilities included High Throughput Screening (HTS), Materials Management (MM) and Closed Loop Discovery (CLD) Sample Logistics in support of Cambridge MA lead discovery programs with management responsibility for 8 employees. Screening Technologies enabled a distributed HTS group focused on Pfizer’s DrugPfinder and Gene Family (GPCR, PDE) target portfolios by supporting a diverse array of automated screening platforms including Zeiss uHTSS, BioTrove High Throughput Mass Spectrometry (HTMS), Evotec Clarina, Caliper LabChip and Staccato automation systems, and numerous liquid handling workstations, microtiter plate readers and washers. Active member of global governance councils, steering committees, working groups and limited duration teams focused on developing and implementing global best practices including Advanced Screening Council (ASC), MM Council, CLD Sample Logistics Domain, Biological Data Store (BDS) Business Rules Committee, Evotec Collaboration Steering Committee, ASC IT Working Group, ASC Diversity Subset Screening Initiative, Titian Software Implementation Working Group, and ASC HTS Annual Meeting Planning Committees.

Supervisory responsibility for 6 employees focused on High Throughput Screening, Materials Management Sample Logistics support of early lead discovery projects in the Drug Pfinder and Gene Family target portfolios including G-Protein Coupled Receptors (GPCRs), kinases, proteases and numerous other target classes. Actively contributed to the identification of new targets for the Drug Pfinder and GPCR gene family portfolios through a global network of Therapeutic Area Project Team liaisons. Championed the implementation of the BioTrove High Throughput Mass Spectrometer (HTMS) tape-based screening system and specification of a second-generation plate based HTMS system.

Supervisory responsibility for 3 direct reports focused on High Throughput Screening of early lead discovery projects in the Drug Pfinder and Gene Family target portfolios including G-Protein Coupled Receptors (GPCRs), kinases and various other enzyme target classes. Actively contributed to the identification of new targets for the Drug Pfinder and GPCR gene family portfolios through a global network of Therapeutic Area Project Team liaisons. Championed the design, performance qualification and implementation of the BioTrove High Throughput Mass Spectrometer tape-based system.

Laboratory supervisor with 3 direct reports focused on the design, development and implementation of protein purification processes for the large-scale cGMP manufacture of therapeutic proteins. Project leader for cGMP manufacture of Phase I clinical supply of therapeutic protein for contract manufacturing customer. Member of the D2E7 clinical supply manufacturing team, a fully human anti-TNFα monoclonal antibody now marketed by AbbVie as HUMIRA. Lead scientist for purification process development in collaboration exploring the feasibility of transgenic expression of human antibodies in goat milk.