Experience

DSI - DS InPharmatics, a PLG company

• United States
• Business Consulting and Services
• 1 - 100 Employee

• Sr. Biologics Manufacturing Consultant

  • Nov 2018 - Present

  Experienced BioChemical Engineer Consulting for clients in the Pharmaceutical and Biotech industries. Expertise in GMP manufacturing, scale up, technical transfer, CMO/CDMO selection and management, process evaluation, improvement and troubleshooting, project management, effective team building and management. Experienced BioChemical Engineer Consulting for clients in the Pharmaceutical and Biotech industries. Expertise in GMP manufacturing, scale up, technical transfer, CMO/CDMO selection and management, process evaluation, improvement and troubleshooting, project management, effective team building and management.



Independent Consultant

• New Hope, Pennsylvania

• Senior BioPharmaceutical Consultant

  • Jan 2018 - Present

  Extensively experienced Pharmaceutical Expert providing strategy, planning, guidance, recommendations, analysis, and knowledge in Process Development, Manufacturing, Scale-Up, Tech Transfer, Facility Design, CMC Requirements, CMO Selection/Management, Supply Chain, and Regulatory Submission Planning and Preparation for client’s Biopharmaceuticals, Chemical and Liposomal drug products. Recent Activities: • Compiled comparison of proposals from international CMOs leading to selection of… Show more Extensively experienced Pharmaceutical Expert providing strategy, planning, guidance, recommendations, analysis, and knowledge in Process Development, Manufacturing, Scale-Up, Tech Transfer, Facility Design, CMC Requirements, CMO Selection/Management, Supply Chain, and Regulatory Submission Planning and Preparation for client’s Biopharmaceuticals, Chemical and Liposomal drug products. Recent Activities: • Compiled comparison of proposals from international CMOs leading to selection of Italian CMO • Guided and advised client team through challenges: technology transfer, selecting materials and securing supply chain, GMP audits of vendors, establishing communication channels with suppliers and CMO, scale up requiring process development, Quality requirements, and regulatory submission details • Contributed to client’s CMC team for submission to EMA and answered follow-up questions • Assisted in preparing a CMO in Europe for an FDA GMP audit • Participated in process design for second generation licensed drug • Wrote the technical section of a Request For Proposal for CMO bids to produce a licensed drug • Technical interface with CMOs. Assisted CMOs in their preparation of proposals to become a second manufacturing site for a licensed drug • Secured drug product supply by providing process knowledge input and applying experimental design guidance to obtain data which led to process improvements and manufacturing robustness • Collaborated with client’s internal manufacturing team to bring a new product and technology to their existing manufacturing site Show less Extensively experienced Pharmaceutical Expert providing strategy, planning, guidance, recommendations, analysis, and knowledge in Process Development, Manufacturing, Scale-Up, Tech Transfer, Facility Design, CMC Requirements, CMO Selection/Management, Supply Chain, and Regulatory Submission Planning and Preparation for client’s Biopharmaceuticals, Chemical and Liposomal drug products. Recent Activities: • Compiled comparison of proposals from international CMOs leading to selection of… Show more Extensively experienced Pharmaceutical Expert providing strategy, planning, guidance, recommendations, analysis, and knowledge in Process Development, Manufacturing, Scale-Up, Tech Transfer, Facility Design, CMC Requirements, CMO Selection/Management, Supply Chain, and Regulatory Submission Planning and Preparation for client’s Biopharmaceuticals, Chemical and Liposomal drug products. Recent Activities: • Compiled comparison of proposals from international CMOs leading to selection of Italian CMO • Guided and advised client team through challenges: technology transfer, selecting materials and securing supply chain, GMP audits of vendors, establishing communication channels with suppliers and CMO, scale up requiring process development, Quality requirements, and regulatory submission details • Contributed to client’s CMC team for submission to EMA and answered follow-up questions • Assisted in preparing a CMO in Europe for an FDA GMP audit • Participated in process design for second generation licensed drug • Wrote the technical section of a Request For Proposal for CMO bids to produce a licensed drug • Technical interface with CMOs. Assisted CMOs in their preparation of proposals to become a second manufacturing site for a licensed drug • Secured drug product supply by providing process knowledge input and applying experimental design guidance to obtain data which led to process improvements and manufacturing robustness • Collaborated with client’s internal manufacturing team to bring a new product and technology to their existing manufacturing site Show less



Jazz Pharmaceuticals (Celator Pharmaceuticals)

• Vice President, Manufacturing and Technical Operations

  • Nov 2013 - Dec 2017

  Added accountabilities since Acquisition by Jazz: Led the CMC team assembling all components of Module 3 Supporting establishment of Manufacturing Support Laboratory Key interface with FDA on CMC topics Interfaced with FDA during PAI leading to successful product approval August 3, 2017 Celator Pharmaceuticals was acquired by Jazz Pharmaceuticals in July 2016.

• VP Mfg and Tech Ops

  • 2013 - 2016

  Developed and executed the manufacturing and supply chain activities for Celator in support of clinical demands and to maximize Celator’s total commercial potential Optimized the company’s production processes, supply chain logistics, quality and cGMP compliance. Assured reliability and cost effectiveness of manufacturing assets and aligning U.S. and Ex-U.S. service providers to ensure the continuous flow of high quality products on time and on budget Worked closely with Celator’s… Show more Developed and executed the manufacturing and supply chain activities for Celator in support of clinical demands and to maximize Celator’s total commercial potential Optimized the company’s production processes, supply chain logistics, quality and cGMP compliance. Assured reliability and cost effectiveness of manufacturing assets and aligning U.S. and Ex-U.S. service providers to ensure the continuous flow of high quality products on time and on budget Worked closely with Celator’s suppliers and contract manufacturing organizations for efficient production planning and to support the introduction of new products into the company’s production cycles Ensured operations are in full FDA, cGMP, OSHA, DEA and MEA compliance



Laureate Biopharmaceutical Services

• United States
• Biotechnology Research
• 1 - 100 Employee

• Vice President, Operations

  • Jan 2012 - Oct 2013

  CMO dedicated to mammalian cell culture. Manufacturing commercial and clinical, bulk and fill/finished biologic products for Contract Manufacturing Clients. Leading eight Departments: Upstream Process Development, Downstream Process Development, Upstream Manufacturing, Downstream Manufacturing, Facilities and Engineering, IT, Sterile Filling, and Supply Chain. Establishing electronic systems, leading Six Sigma/Lean Program, bringing in best industry practices. Building a best in class… Show more CMO dedicated to mammalian cell culture. Manufacturing commercial and clinical, bulk and fill/finished biologic products for Contract Manufacturing Clients. Leading eight Departments: Upstream Process Development, Downstream Process Development, Upstream Manufacturing, Downstream Manufacturing, Facilities and Engineering, IT, Sterile Filling, and Supply Chain. Establishing electronic systems, leading Six Sigma/Lean Program, bringing in best industry practices. Building a best in class operations team and driving the expansion of the business. Assuring delivery to promise and quality right first time. Developing personnel and improving facility and equipment. Assuring top talent selection for key hires. Driving a quality and performance culture. Show less CMO dedicated to mammalian cell culture. Manufacturing commercial and clinical, bulk and fill/finished biologic products for Contract Manufacturing Clients. Leading eight Departments: Upstream Process Development, Downstream Process Development, Upstream Manufacturing, Downstream Manufacturing, Facilities and Engineering, IT, Sterile Filling, and Supply Chain. Establishing electronic systems, leading Six Sigma/Lean Program, bringing in best industry practices. Building a best in class… Show more CMO dedicated to mammalian cell culture. Manufacturing commercial and clinical, bulk and fill/finished biologic products for Contract Manufacturing Clients. Leading eight Departments: Upstream Process Development, Downstream Process Development, Upstream Manufacturing, Downstream Manufacturing, Facilities and Engineering, IT, Sterile Filling, and Supply Chain. Establishing electronic systems, leading Six Sigma/Lean Program, bringing in best industry practices. Building a best in class operations team and driving the expansion of the business. Assuring delivery to promise and quality right first time. Developing personnel and improving facility and equipment. Assuring top talent selection for key hires. Driving a quality and performance culture. Show less



Avid Bioservices

• United States
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Vice President, Manufacturing Operations

  • Dec 2010 - Jan 2012

  Manufacturing commercial and clinical, bulk and fill/finished biologic products for our parent company -Peregrine Pharmaceuticals, Contract Manufacturing Clients, and the U.S. Government. Leading four Departments: Manufacturing, Facilities and Engineering, Manufacturing Science and Technology, and Supply Chain. Established Six Sigma/Lean Program and methods throughout the company. Improved system capabilities, optimizing capacity, assuring reliability and preparing for facility… Show more Manufacturing commercial and clinical, bulk and fill/finished biologic products for our parent company -Peregrine Pharmaceuticals, Contract Manufacturing Clients, and the U.S. Government. Leading four Departments: Manufacturing, Facilities and Engineering, Manufacturing Science and Technology, and Supply Chain. Established Six Sigma/Lean Program and methods throughout the company. Improved system capabilities, optimizing capacity, assuring reliability and preparing for facility expansion. Prepared personnel, processes and facilities for FDA biannual inspection and for PAI. Developed personnel and assuring top talent selection for key hires. Driving step change in performance of Manufacturing, Support groups, and Quality organizations. Show less Manufacturing commercial and clinical, bulk and fill/finished biologic products for our parent company -Peregrine Pharmaceuticals, Contract Manufacturing Clients, and the U.S. Government. Leading four Departments: Manufacturing, Facilities and Engineering, Manufacturing Science and Technology, and Supply Chain. Established Six Sigma/Lean Program and methods throughout the company. Improved system capabilities, optimizing capacity, assuring reliability and preparing for facility… Show more Manufacturing commercial and clinical, bulk and fill/finished biologic products for our parent company -Peregrine Pharmaceuticals, Contract Manufacturing Clients, and the U.S. Government. Leading four Departments: Manufacturing, Facilities and Engineering, Manufacturing Science and Technology, and Supply Chain. Established Six Sigma/Lean Program and methods throughout the company. Improved system capabilities, optimizing capacity, assuring reliability and preparing for facility expansion. Prepared personnel, processes and facilities for FDA biannual inspection and for PAI. Developed personnel and assuring top talent selection for key hires. Driving step change in performance of Manufacturing, Support groups, and Quality organizations. Show less



ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company

• Biotechnology Research
• 200 - 300 Employee

• Sr. Director of Manufacturing

  • Jul 2009 - Nov 2010

  Manufacturing responsibility for bulk commercial and clinical products. Manufactured commercial and all clinical biologic products supporting clinical trials worldwide Brought second production suite online Received tech transfer and successfully scaled up two new clinical pipeline products Reorganized departments to align with staff reductions associated with Lilly's plan Infused accountability for communication and for safety across organization Supported energy reduction plan… Show more Manufacturing responsibility for bulk commercial and clinical products. Manufactured commercial and all clinical biologic products supporting clinical trials worldwide Brought second production suite online Received tech transfer and successfully scaled up two new clinical pipeline products Reorganized departments to align with staff reductions associated with Lilly's plan Infused accountability for communication and for safety across organization Supported energy reduction plan Initiated Operational Excellence (5S and Lean) throughout Manufacturing Designed reassignments and supported shutdown of a manufacturing plant Participated in improvement projects and design of new business processes Guided business maturation and transition Front room expert for Partner and Regulatory Inspections Show less Manufacturing responsibility for bulk commercial and clinical products. Manufactured commercial and all clinical biologic products supporting clinical trials worldwide Brought second production suite online Received tech transfer and successfully scaled up two new clinical pipeline products Reorganized departments to align with staff reductions associated with Lilly's plan Infused accountability for communication and for safety across organization Supported energy reduction plan… Show more Manufacturing responsibility for bulk commercial and clinical products. Manufactured commercial and all clinical biologic products supporting clinical trials worldwide Brought second production suite online Received tech transfer and successfully scaled up two new clinical pipeline products Reorganized departments to align with staff reductions associated with Lilly's plan Infused accountability for communication and for safety across organization Supported energy reduction plan Initiated Operational Excellence (5S and Lean) throughout Manufacturing Designed reassignments and supported shutdown of a manufacturing plant Participated in improvement projects and design of new business processes Guided business maturation and transition Front room expert for Partner and Regulatory Inspections Show less



Genentech

• United States
• Biotechnology Research
• 700 & Above Employee

• Director Operational Excellence

  • Apr 2008 - Jul 2009

  Enterprise level director effecting high impact changes leading to improvements and efficiency. Identified $100MM cost opportunity in Bulk Inventory Initiated and Promoted infusion of Lean throughout Genentech Designed and supported implementation of Manufacturing Reorganization Model Created and leveraged benchmarking opportunities with peer companies Participated in improvement projects and design of new business processes Constructed Due Diligence package

• Director of Manufacturing

  • Aug 2006 - Apr 2008

  Completed the construction, validation and started up the new 8X25kL biopharaceutical plant. Flawless execution of media runs and qualification runs. Built and directed the upstream manufacturing team partnering closely with Quality, Validation and Engineering.



Bristol Myers Squibb

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director, Process Leader, Large Scale Project (mammalian cell)

  • Jan 2006 - Aug 2006

  Requested and was approved $660 million to build a full service biologics drug substance manufacturing plant (6x20kL capacity) Organized and Led process engineering collaboration with Fluor design team Accountable for timeline and Operations expense budget ($110MM) Owner and accountable for outcomes: capacity, operability, safety, cost and quality of products Communicated the project progress to upper management and support groups Recruited design team members and obtained… Show more Requested and was approved $660 million to build a full service biologics drug substance manufacturing plant (6x20kL capacity) Organized and Led process engineering collaboration with Fluor design team Accountable for timeline and Operations expense budget ($110MM) Owner and accountable for outcomes: capacity, operability, safety, cost and quality of products Communicated the project progress to upper management and support groups Recruited design team members and obtained cooperation/collaboration of knowledge owners Interfaced with Fluor, BMS Global Engineering, Quality, Regulatory and Senior Leadership Created staffing plan for new facility; 400+ headcount, stand alone manufacturing capability

• Director, Manufacturing Operations (mammalian cell)

  • Jun 2001 - Jan 2006

  Led Commercial and Clinical Manufacturing Operations for multi-product facility Directed Six Departments and 225 FTE: Materials Management, Inoculum, Cell Culture, Purification, Facilities and Engineering, Training and Strategic Support Controlled budgets: $50 MM Operations budget and $40 MM Capital budget Attained licensure after passing FDA pre-approval inspection for BMS' first biologic product Prepared facility and personnel for FDA inspection Transformed a Development… Show more Led Commercial and Clinical Manufacturing Operations for multi-product facility Directed Six Departments and 225 FTE: Materials Management, Inoculum, Cell Culture, Purification, Facilities and Engineering, Training and Strategic Support Controlled budgets: $50 MM Operations budget and $40 MM Capital budget Attained licensure after passing FDA pre-approval inspection for BMS' first biologic product Prepared facility and personnel for FDA inspection Transformed a Development facility into a fully cGMP compliant Manufacturing facility Recruited, interviewed and hired key managers to build new manufacturing capability Achieved six-fold increase in capacity within two years Led facility reliability capital investment to debottleneck utilities capacity Implemented my strategy for rapid hiring and training of Technicians Built in-house rapid training programs for floor supervisors and non-exempt personnel Grew the Operations function from 60 FTEs to over 225 FTEs in less than two years Co-led a cross divisional product team to develop and manufacture a biologic product through phase II and into phase III Promoted company in the community



fungal

• Associate Director, Chemical Development Pilot Plants (bacterial

  • Jan 2000 - Jun 2001

  Controlled operations and personnel in two Fermentation and three Recovery pilot plants Accountable for technical transfer of fermentation processes to manufacturing operations and technical consultation for production scale including plant design Coordinated timing of product delivery requirements balanced with each pilot plant's capabilities Controlled operations and personnel in two Fermentation and three Recovery pilot plants Accountable for technical transfer of fermentation processes to manufacturing operations and technical consultation for production scale including plant design Coordinated timing of product delivery requirements balanced with each pilot plant's capabilities



Phyton GmbH (plant cell)

• General Manager Pro Tem

  • Jul 1999 - Jan 2000

  Commanded all GM activities for this start-up company producing paclitaxel via plant cell fermentation until the GM position was filled by a citizen of Germany Completed Technical Transfer and demonstrated process performance at 70,000-L scale Set up business units to normalize activities; safety, quality, production, warehouse and shipping Participated in candidate selection for key management Commanded all GM activities for this start-up company producing paclitaxel via plant cell fermentation until the GM position was filled by a citizen of Germany Completed Technical Transfer and demonstrated process performance at 70,000-L scale Set up business units to normalize activities; safety, quality, production, warehouse and shipping Participated in candidate selection for key management



Bristol Myers Squibb

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Operational Excellence Consultant

  • Nov 1998 - Jul 1999

  Operational Excellence Consultant and Lead (B-MS, Swords, Ireland; Conducted analysis, found yield improvement opportunities for two products produced via chemical synthesis. Formed three teams achieving results netting $1MM USD savings annually Coached seven teams to successful completion of their charters; saving another $1MM USD Improved safety and enhanced communications Operational Excellence Consultant and Lead (B-MS, Swords, Ireland; Conducted analysis, found yield improvement opportunities for two products produced via chemical synthesis. Formed three teams achieving results netting $1MM USD savings annually Coached seven teams to successful completion of their charters; saving another $1MM USD Improved safety and enhanced communications



Multi-Product (fungal)

• Fermentation Department Manager

  • Apr 1994 - Nov 1998

  Responsible for Antibiotic Production and Personnel Products: Penicillin V, Cephalosporin, Kanamycin, and Penicillin V Amidase Enzyme Managed budgets: $30MM material budget, $4MM compensation budget, $6MM expense budget Responsible for Antibiotic Production and Personnel Products: Penicillin V, Cephalosporin, Kanamycin, and Penicillin V Amidase Enzyme Managed budgets: $30MM material budget, $4MM compensation budget, $6MM expense budget



Bristol Myers Squibb

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Fermentation Manufacturing Production Engineer

  • Oct 1991 - Apr 1994

  Accountable for smooth fermentation production operations; 20 fermenters ranging in size from 10,000 gallons to 45,000 gallons and harvesting in excess of 500,000 gallons per week Responsible for production support operations; batch plant, sterilization equipment, control equipment, and the seed plant (32 seed reactors; 10 gallons to 1000 gallons) Accountable for smooth fermentation production operations; 20 fermenters ranging in size from 10,000 gallons to 45,000 gallons and harvesting in excess of 500,000 gallons per week Responsible for production support operations; batch plant, sterilization equipment, control equipment, and the seed plant (32 seed reactors; 10 gallons to 1000 gallons)



Coors Biotech

• Fort Collins, Colorado

• Bioprocess Development Engineer

  • Feb 1987 - Oct 1991

  Process development for vitamins and food colorants. Plant start up Technical Transfer Process development for vitamins and food colorants. Plant start up Technical Transfer