ACCOMPLISHED INDUSTRIAL OPERATIONS MANAGEMENT SPECIALIST
EXPERT IN PHARMACEUTICAL MANUFACTURING AND SUPPLY
Commercially minded strategist with deep technical knowledge in process, analytical and regulatory areas.
Game-changer in executing on objectives; singularly successful in meeting or exceeding targets and timelines on major issues. Sterling reputation for delivering initiatives with an eye to the bottom line and always at a high level of compliance with minimal liability. Able to bridge all technical groups and functional areas to the commercial component. Visionary and systematic in anticipating and addressing business challenges, constraints and opportunities. Highly organized with a focus on clear, concise and consistent communications with all constituents and stakeholders.
Hands on experience with both large and small molecules in multiple dosage forms
Extensive global experience
Multi-lingual: Fluent in Spanish and English; conversationally competent in Portuguese
Experienced practitioner of several manufacturing optimization tools ? LEAN, JIT, KANBAN, SMED, Value Engineering & Cycle Time Optimization
2015 - 2016 VP GLOBAL SUPPLY OPERATIONS, EPIRUS BIOPHARMACEUTICALS
Stabilized & extended supply of commercialized product after prior contractual breach with DS/DP supplier
Developed design and operating and cost model for a 6 x 2000L Drug Substance facility based on modular / pod construction and disposable equipment technology for the production of Monoclonal Antibodies.
RFP and supplier selection for both Drug Substance and Drug Product CMOs for commercial production of Infliximab (Remicade biosimilar)
Successful completion of 1000l Drug Substance and Drug Product GMP batches to support phase 3 clinical study
2011 - 2014 SVP TECHNICAL OPERATIONS, CUBIST PHARMACEUTICALS
Successful selection and integration of 3 acquisitions in the last 3 years: Adolor, Trius and Optimer
Developed and instituted governance systems for Operations management including: CMO oversight, Sales & Operations Planning and Product Development / CMC and Quality.
Successfully managed continuity of commercial supply and development program timeliness through serious technical hurdles.
Developed and executed organization design to support >20% growth and multiple phase 3 programs, including Process Development, Supply Chain, Manufacturing and QA / QS / QC.
Developed long term manufacturing network supply chain strategy for the Board of Directors including contingency supply and partial internalization of manufacturing.
Successful validation and launch of Sivextro with product availability with 24hrs of PDUFA
Successful validation of Ceftolozane-Tazobactam API, DPI and DP site readiness for validation in 4Q14
Joint Steering Committee member representing Cubist with strategic commercial partners including Novartis, Astra Zeneca, Merck, Bayer, and Astellas.
Actively managed a complex 20 site CMO manufacturing network including Starting Materials, API, and DP for Sterile and Oral formulations at a global scale including Wuxi, Qilu, ACS Dobfar, Biocon. AMRI, Hospira, Baxter, Steripharma, and Patheon
Established Technical Sourcing processes for the selection and integration of product suppliers forged new and renegotiated existing supply agreements, quality agreements including capital expansions.
1991 to 2011 BRISTOL-MYERS SQUIBB
Recognized peak performer whose career trajectory is based on accomplishments in a diversity of international and domestic site, regional and corporate roles from shop floor supervisor to business unit leader in highly matrixed organization.
VP LATIN AMERICA, ASIA PACIFIC & JAPAN
Added Mexico, Ecuador and Brazil to regional operations management portfolio in Asia as well as product supply management to all markets within region as requested by VP of Operations. Execute full P&L across 5 facilities with $82MM in direct expenses and 1,200 headcount operating at $4MM favorable to budget. Member of Worldwide (WW) Technical Operations Senior Management Committee also responsible for WW Product Transfers.
? Developed and executed strategy for targeted closure of 3 facilities within 16 months to yield $17MM cost reduction and $35MM in asset sales. Managed ongoing coordination and implementation of Latin America restructuring including closing plants in Mexico, Ecuador and Brazil, related technical transfers and market portfolio streamlining and supply strategy. Devised strategy and capital plan for expansion of remaining Mexican facility to run additional volumes; presented business case for $5MM investment to ensure operational integrity as volume increases by 40%.
? Coordinated establishment of 3rd-party manufacturing capabilities in Brazil.
? Developed and executed supply and regulatory plan for plant divestiture and strategy for consolidation of WW Stability labs to 3rd-party in China.
VP ASIA PACIFIC & JAPAN ~ SINGAPORE
(2008 - 2009)
Led divestiture of multiple facilities and brands as company evolved its manufacturing strategy and product portfolio toward low volume/high value biologics. Accepted promotion to regional operations management role with direct responsibility for 5 facilities in Japan, China, Pakistan, Australia and Indonesia, $56MM in direct expenses and 900 headcount. Met challenges of leading manufacturing operations (operated at $8MM favorable to budget) while executing divestitures with minimal resources and a very compact team.
? Developed and successfully executed strategy for divestiture of 3 facilities within 16 months to yield $8MM in cost reduction and $280MM in asset sales.
? Exited market entirely in Pakistan and Indonesia in 1 year. Managed start-to-finish market exit and divestiture of entire business entity, partnering with the commercial marketing and sales teams in Pakistan and Indonesia on due diligence, bidding process, negotiations and contract finalization.
? Far exceeded corporate expectations on divestiture of Australian operation. Diverged from corporate strategy, presenting value-added proposal to sell rather than shutter facility. Initiated and concluded discussions with potential buyer, inking a $40MM win-win contract for company that precluded major job losses and preserved commercial presence. Recommended by CEO for and honored with President?s Award.
SITE VP & GM ~ PUERTO RICO
(2003 - 2008)
Rendered highly effective leadership during critical transitional phase as multi-operational site (i.e., 4 pharmaceutical finishing and 5 chemical operations) ceased chemical operations while expanding pharmaceutical. Executed $60MM P&L performance accountability in 700+-employee facility generating $4B in company sales (i.e., ~25% of overall sales revenues) and producing 5 of the company?s top sales products with a focus on quality & compliance and safety & environmental issues.
? Closed all chemical operations without any strikes, labor unrest or quality problems. Managed coordination and implementation of downsizing strategy including labor/management communications (particularly, severance packages), site master planning and handling of personnel issues (i.e., possible transfers to pharmaceutical operation).
? Implemented a series of operational improvements in thermal oxidizer operations to resolve performance issues. Achieved successful submission of site?s first NOCSR report under EPA MACT requirements.
? Developed business case for and executed $30MM capital project. Developed and implemented Drug Product optimization strategy, including capacity planning, facility and equipment upgrades, systems improvements and organizational design to expand operation in support of 4 of company?s top sales products.
? Closed 2 FDA audits with zero 483?s and a third with 3 minor observations, shielding high value products from adverse regulatory impacts. Additionally, propelled significant improvements in all site metrics (i.e., customer service, financial performance, safety performance, etc.).
DIRECTOR OF TECHNICAL OPERATIONS ~ SPAIN
(2000 - 2002)
Executed full P&L accountability across 2 divisional business unit operations (medical device packaging & distribution and pharmaceutical production). Managed full scope of General Manager role, invoking Spanish language fluency to direct 8 fixed and 104 indirect local staff reports. Reported to France-based VP of Europe. Despite maturity of brands, intense cost pressure and productivity of operation (i.e., facility had 1 of the lowest conversion costs in the network at $.10/unit), generated six-digit cost savings on $16MM P&L volume.
? Developed and implemented $2MM pharmaceutical plant strategic capital plan with 2-year payback on facilities upgrade, balancing GMP and productivity improvement needs with product cost pressures.
? Reaped $200,000 in annual cost savings, improved EHS compliance and enabled superior product quality via implementation of product formulation change. Led execution of equipment purchases, trial batches, validation / stability protocols and Ministry of Health (Spain?s FDA equivalent) approval.
? Executed physical relocation of distribution & packaging operation, including union negotiations, leasing contracts, facility layout design and internal construction plan.
? Groomed local manager as successor. Devised succession and development strategy for key staff positions.
SITE SUPPORT ~ PUERTO RICO
Challenged to optimize operations and maximize capacity of pharmaceutical production facility beset with quality issues while preparing 3 new product launches simultaneously. Temporary site support assignment.
? Enabled 25% increase in capacity to support critical diabetes drug operations, operating on 3-shift/6-day basis. Developed capacity utilization and scheduling analysis to support accelerated introduction of incremental volumes and implemented minor investment plan.
? Developed comprehensive procedural changes to prevent recurrence of several severe quality incidents. Coordinated QA and manufacturing investigations to discover root causes. Additionally, provided contingency scheduling to ensure timely market launch in lieu of quarantined products.
? Reconfigured costing and planning structures and developed manufacturing standards, yields and capacity plan for 2001 budget.
DIRECTOR OF TECHNICAL OPERATIONS APMEA
(1998 - 2000)
Promoted to roll out a series of corporate initiatives, troubleshoot P&Ls, participate in capital planning, product sourcing and service issue resolution, and support plant operations across broad region encompassing multiple facilities throughout Asia Pacific (i.e., China, Japan), Middle East (Pakistan, Egypt) and Africa.
? Coordinated 20% SKU reduction in region across 18 markets using gross margin and migration analysis.
? Negotiated 30% reduction in price on 3rd-party contract in Pakistan, avoiding potential tax exposure of >$1MM. Successfully negotiated additional foreign contracts and supply agreements.
? Coordinated establishment of 3rd-party manufacturing capabilities in Saudi Arabia.
MANUFACTURING MANAGER / ASSOCIATE DIRECTOR ~ AUSTRALIA
(1995 - 1998)
Volunteered for ex-pat assignment to stabilize Australian plant experiencing severe growth. Led all Manufacturing and Packaging operations in facility producing 18MM units annually during transitional phase between General Managers. Managed 8 direct reports (area managers, supervisors, Quality Assurance, Training & Development) and 106 machine operator and QA inspector indirect reports. Held direct budget responsibility for $7.5MM in expenses. Promoted to Associate Director, Manufacturing in 1998.
? Achieved overall increase in units per direct labor hour of 46%, while absorbing 30% increase in volume.
? Developed and negotiated profound union agreement changes worth ~$200,000 annually.
? Doubled size of Packaging area; participated in development/implementation of major capital expansions.
? Elevated monthly customer service levels to corporate target of 95% for overall local and export delivery performance from an average of 80% in 1994 and 1Q 1995.
? Established Training & Development organization consistently recognized as best practice by internal and external auditors, slashing customer quality complaints 50%.
MANAGER INDUSTRIAL ENGINEERING / INTERCONTINENTAL
(1994 - 1995)
Championed by VP of Latin America to transition into regional group supporting industrial engineering projects in Latin America, Asia / Pacific and Middle East plant operations. Reported to VP of Intercontinental Operations. Completed a series of multi-country / multi-plant initiatives impacting operations worldwide.
? Achieved 50% reduction in cycle days in 3 offshore facilities via customization of US Cycle Time Reduction Methodology. Led and trained local management teams in defining target facilities and implementing rigorous evaluation methodology, reaping significant results with minimal investment.
? Developed Intercontinental?s first Strategic Plan covering 17 facilities in 13 countries in conjunction with Finance and VP of Operations. Performed first cost evaluations for the region defining major cost drivers, organizational development needs and sourcing alternatives.
? Developed first inclusive benchmarking study of all finishing operations worldwide. Benchmark data focused on cost efficiency and productivity of 33 plants and provided an accurate and quick estimation model of costs under various plant reconfiguration scenarios.
SENIOR INDUSTRIAL ENGINEER INTERNATIONAL
(1991 - 1994)
Completed a series of projects in support of European and Mexican operations; reported to Director of International Industrial Engineering. Assisted with annual development of Technical Operations annual strategic plan and budget processes.
? Developed and implemented yield improvement program at 3 Mexican pharmaceutical plants. Capitalized on Spanish language fluency to work alongside local Industrial Engineering staff to develop data collection and statistical analysis package for identification of yield loss points in high-value processes. Mexican teams realized $500,000 in yield improvements over 2 years.
? Worked closely with VP of International Operations and European plant managers to develop network optimization plans for Europe. Developed cost estimates (e.g., operating, capital, etc.) for financial modeling and configuration option offering a $60MM total operating cost reduction presented to senior corporate management.
? Enabled 30% volume increase while reducing headcount by 2 via redesign of pick and pack area of promotional materials distribution operation in Evansville, Indiana.
STERILE OPERATIONS SUPERVISOR
(1987 - 1991)
Joined company as a Cooperative Education Program Intern. Gained shop floor supervisory experience on 2nd shift packaging operation with 25 unionized hourly employees. Accepted permanent employee status (June 1987), assuming management of 60 employees.
BS / Industrial Administration ? ? NEW JERSEY INSTITUTE OF TECHNOLOGY, Newark, NJ