Pharmaceutical CMC Expert

Expertise

• Pharmaceutical chemistry manufacturing and control.
• Small virtual pharmaceutical manufacturing.
• Materials management and control.
• Pharmaceutical quality assurance.
• Technical services.

Experience

Undisclosed Company, Managing Principal, 2010 - Present

• Provide service to virtual pharmaceutical and biotechnology industry in the areas of supply chain, manufacturing, project management, quality and compliance.

Projects

• Led CMC development team for a Phase I/II small molecule program.
• Performed CMC due diligence for clinical phase products.
• Performed a supply chain quality and technical gap assessment for small biotechnology company.
• Developed Supply Chain SOPs, based on best in class practices, for small biotechnology company.
• Developed GMP Phase I quality system for a small biotechnology company.
• Sourced API and custom intermediates including establishment of systems for import, audit, and contracts.
• Developed COGS model for novel drug delivery technology.
• Acted as Head of Quality for a biotechnology company. Activities included establishment of GXP quality systems for outsourced manufacturing, clinical, outsourced toxicology, and in-house bioanalytical group.
• Wrote CMC sections for initial IND and updates for IND and CTD.
• Wrote cold chain shipping study report.

Oscient Pharmaceuticals, Waltham, MA, 2002 - 2010

Vice President Technical Operations and Quality, 2010

• Oversight included process development, technical services, supply chain, logistics, purchasing, quality assurance, and quality control for a $90 million revenue company.
• Provided strategic oversight to Directors of the quality and technical operations function.
• Led quality executive reporting to compliance committee of board of directors.
• Member of executive management team.
• Launched 2 commercial products and established commercial operations infrastructure from API production through distribution for global virtual manufacturer.
• Manufacturing and distribution sites are located in Europe, Asia, and North America.
• Developed and implemented quality strategy to ensure compliance of vendor qualification program, complaint management, document management, batch release, stability, and annual product review. This resulted in no FDA 483's, reduced cycle time of batch release by 66%, 50% improvement in vendor qualification compliance, and implementation of several quality systems.
• Provided technical support for EMEA submissions, North American submissions, and numerous diligence activities for partnering Oscient products.
• Successfully led technology transfers of a commercial solid oral dose product from a major pharmaceutical manufacturer to a new contracted manufacturing site.
• Optimized the process and completed the transfer 10% under budget and in 6 months.
• Several commercial packaging sites in U.S. for solid oral dosage form completed on time and budget.
• Clinical stage drug product manufacture.
• Clinical API purification from site in Italy to France.
• Several commercial and clinical lab transfers in U..S and Europe.

Senior Director Manufacturing and Supply Chain, 2005 - 2006

Director Clinical and Commercial Technical Operations, 2004 - 2005

Associate Director Pharmaceutical Development, 2002 - 2004

• Responsibilities included: process development, analytical development, authoring CMC sections of IND/NDA, technical transfer and management of third party suppliers for commercial and clinical manufacturing, logistics, and purchasing. In addition, led international virtual development organization in all aspects of CMC for novel anti-infective in Phase I - Phase III trials.
• Within 6 months of starting, created virtual formulations, analytical development, manufacturing, and packaging organization for development of a novel lipoglycodepsipeptide.
• Successfully created a new formulation, manufacturing process, and packaging when existing formulation could not demonstrate sufficient stability for Phase III.
• Oversaw manufactured, packaging, labeling and distribution for Phase I, Phase II, and Phase III, and compassionate use, and Physician sponsored clinical trials conducted in US, Western Europe, Eastern Europe, Canada, and Russia.
• Within 3 months, transferred methods, blinded supplies and placebo, labels, and kitting for international Phase III study of a fluoroquinolone antibiotic.
• Successfully led CMC efforts to create radio-labeled API and capsule for Phase I trial in the U.K. The manufacturing and packaging was completed on time and on budget.
• Led technology transfers and scale-up for process from Spain to Canada and method transfers from Italy to U.S.

Alkermes, Cambridge, MA, 1997 - 2002

Manager Supply Chain and Operations Strategy, 1999 - 2000

• Responsibilities focused on: management of third party suppliers, development of distribution strategy, establishing materials management guidelines and systems, and capacity and cost strategies.
• Defined new corporate process for materials management activities based on implementation of Oracle ERP system. This included development of warehousing /receiving / purchasing/batch production/release/transport process design of system interfaces and reports. Successfully validated system and processes.
• Evaluated and defined sterile powder filling strategy, diluent manufacturing strategy including delivery device evaluation, packaging strategies for several technologies including all financial analysis, RFPs, evaluation matrices, COGS analysis and execution plans.
• Established vendor metrics and oversight system for contract manufacturers and negotiated third party contracts. This resulted in a reduction of lead time from 6 months to 3 months.
• Developed distribution strategy for cold chain product.
• Established API vendor evaluation and approval system that clarified roles/responsibilities, phase appropriate activities, and quality criteria.

Plant Manager, 1997 - 1999

• Responsibilities included: Start-up of sterile product manufacturing facility from build-out to approved commercial production for novel parental drug delivery technology. This included an $18 million budget and management of manufacturing, operations support, warehousing, and calibration/maintenance staff of 40 people including 3 managers and 1 supervisor.
• Hired and trained staff for start-up of sterile drug delivery processing and powder filling operations.
• Led plant staff in validating system, process and equipment and which resulted in an FDA Pre-approval inspection with no 483's and with a timeline of 1.5 years from build-out to manufacture of registration/commercial lots.
• Lead manufacturing contact for client (plant and product was produced for a major pharmaceutical).

HCMR, (Pfizer/CVS Joint Venture), Woonsocket, RI, Manager - Consulting Services, 1997 - 1998

• Responsible for consulting services to pharmaceutical marketing.

Eli Lilly & Company, Indianapolis, IN, 1991 - 1997

Department Head, Biosynthetic Human Insulin Bulk Final Purification, 1995 - 1997

• Responsible for $6 million budget and staff of 27 direct reports consisting of shift supervisors, engineers, production planner, and technical support personnel.
• Facilitated team in reducing budgeted expenses of $6 million by 10% by a reduction in factory losses and changing processes.
• Led personnel in the deployment of a process improvement plan, which included use of statistical process control, and metrics that resulted in a reduction of product deviations of 25% and to improve operations.
• Recognized with the Eli Lilly's Quality Advocate award for teaching operators about statistical process control and the resultant the reduction in variation and resulting improvement in quality.

Department Head Materials Planning Indianapolis Bulk Operations Associate, 1991 - 1995

• Responsible for successful management of over $250 million in inventory, customer services levels, and 7 person staff.
• Initiated and led international and cross-functional BHI (Biosynthetic Human Insulin) supply chain inventory strategy effort to develop an inventory strategy for the chain. The new tactics defined by this group reduced supply chain inventory by $13 million.
• Led a cross-functional team to develop and implement good materials planning practices for 700 person division with over $1 billion in sales. These practices included control systems for rework, inventory turns, lead time, raw material levels, and data quality. The lead-time for all major products was reduced by 20% - 50%.
• Developed and implemented a strategy for a pull inventory system that linked with MRP II for Insulin, which increased throughput by 35% while reducing work-in-process by 5 days.
• Indianapolis bulk operations lead for implementation of new inventory management system.

Verizon, Pittsburgh, PA, 1985 - 1989

• Engineer, Product Manager and Major Account Executive.

Honors & Publications

Academic and Professional Affiliations

• Parenteral Development Association

Awards

• "CMO Selection Criteria" The CMO Leadership Awards Life Science Leader Special.

Conferences

• National and International Invited Symposia and Seminars
• Managing Outsourced Manufacturing, Massachusetts Biotechnology Council
• Technical Transfer, IBC's Annual Biopharm Outsourcing, Partnering, and Contracting Conference, Carlsbad, CA.
• Evaluating the Quality Control oversight at CMO's, IBC's International Outsourcing Manufacturing of Biopharmaceuticals Conference. Carlsbad, CA.
• Int'l Project Teams: Communication, Culture, Personalities, Language, Distance Pharma Chem Outsourcing Conference, Long Branch, NJ.
• How to Salvage a Bad Contractor Relationship, IQPC Tenth Annual Contract Manufacturing for Pharmaceuticals and Biotech Conference, Berkeley, CA.
• Phase Appropriate Procurement/Supply Agreements for Small Companies: Raw Materials, API's, and Suppliers
• Pharma ChemOutsourcing Conference, Long Branch, NJ
• Faculty - Pharmaceutical Process Development (Solids), Center for Professional Advancement, Amsterdam, The Netherlands

Education

• M.B.A. Carnegie Mellon University, Pittsburgh, PA
• B.S. Industrial Engineering, The Pennsylvania State University, University Park, PA