Pharmaceutical Formulation and Process Development-Solid Dosages, Liquids, Capsules, Scale Up, and FDA Regulations

Expertise

• Pharmaceutical formulation development and process transfer, serving over twenty five years' in the pharmaceutical industry.
• Develop products; solid dosages, liquids, capsules, research new technologies, and sustained release technologies.
• Experience with formulation, validation and scale up of all the above named disciplines.
• Supervisor and Manager responsible for staff consisting of formulators, packaging engineers, and equipment engineers.
• Clinical supply manufacturing and troubleshooting processes with successful transfer to process engineering and then to manufacturing.
• Operated and evaluated many types of pharmaceutical equipment including tablet presses, encapsulating machines, fluid bed processes, fluid bed with Wurster insert, high shear granulaters, tablet coaters, PK blenders and other blenders and equipment to make hot melt products.
• Project team player, leader and motivator with the ability to present ideas effectively and communicate well with all levels of management within a matrix environment on a variety of programs and projects.
• Hands on experience as a member of cross functional drug development teams involved with the entire drug development process.
• Possess a high degree of personal motivation and desire to make an immediate contribution to the growth and profitability of the corporation with a distinctive sense of urgency.
• Pharmaceutical industry regulations: FDA guidelines, standard operating procedures, cGMP standards and OSHA practices.
• Raw material sourcing.
• Pharmaceutical contact negotiations; CMO's and CRA's

Expert Witness Experience

• Deposition work: Witness - Formulator of a product that had a formula patent - Case Won.
• Witness - A company not fulfilling their contractual agreements - Case Won

Experience

Independent Contractor, 2008 - Present

Projects

Herbalife Inc., Winston Salem, NC, Senior Technical Operations Scientist, 2013 - 2014

• Directly responsible for the implementation and set up of a new research and development facility at this newly constructed plant.
• Oversee several scientists and engineers in the pilot manufacture of new and existing products transferring to a new facility.
• Responsible for the development and scale up of new formulations to be manufactured at the new plant.
• Work with other scientists globally to troubleshoot and develop products on a worldwide scale within the Herbalife Company.
• Involved in making the new Winston Salem research and development facility into a Center of Scientific Excellence for Herbalife.

Axcentria Pharmaceutical, Sellersville, PA, Technical Operations, 2010 - 2013

• Oversee manufacturing, analytical and general operations of a new start up pharmaceutical manufacturer.
• Assist in business development to uncover client technical needs and prepare contract proposals.
• Provide technical guidance to the President and Quality Assurance to assure scientifically and technically sound practices.
• Formulate new products for the over the counter market as well as new prescription products specifically, in the area of liquids and semisolids as well as solid dosage forms.

Pharm Ops, Phillipsburg, NJ, Project Manager and Operations Manager, 2010 - 2010

• Assisted in business development to uncover client technical needs, prepared contract proposals and managed formulation development of solids and liquid products and manufactured clinical batches.
• Added two new business contracts to achieve the goals of the company.
• Managed all projects from initiation to final clinical batch manufacture for IND and ANDA applications.

Frontage Laboratories, Exton, PA, CMC Client Services, 2008 - 2010

• Worked with business development to identify and discuss new projects for this Contract Research and Manufacturing Company.
• Directly responsible for discussing technical needs of new clients and authoring proposals for new contracts for the company.
• Project manager for formulation development and clinical batch manufacture projects that were brought into the company.
• Worked directly with the analytical, developmental and clinical manufacturing groups in implementing and finalizing projects.
• Increased new business growth 30%.
• Organized production and manufacturing capabilities, driving income to increase by 40%.

Professional Employment Experience

McNeil Consumer & Specialty Pharmaceuticals, PA, Principal Scientist/Manager, 2005 - 2006

• Key management position reporting to the Associate Director of new products.
• Responsible to develop, plan, organize and conduct research experiments to develop solid and liquid dosage forms from early development to launch phase.
• Acted as manager over two scientists and two contract scientists.
• Worked directly with the joint venture group at J&J/Merck.
• Assisted team members in managing multiple projects in a timely and compliant manner.
• Successfully developed two new liquid formulations through validation and two solid formulations.
• Successfully reestablished the J&J/Merck joint venture projects within McNeil.
• Written CMC sections for NDA application for Pepcid Smooth Dissolve product.

Teva Pharmaceuticals USA, PA Associate Director, Technology Applications, 2000 - 2004

• Key management position reporting to Senior Director of pharmaceutical research and development.
• Responsible for identifying and developing new technology platforms and directing scientists to formulate ANDA's for the company.
• Focused mainly on the development of extended and sustained release dosage forms.
• Successfully helped in the development of eleven new ANDA's for Teva.
• Increased the capacity for manufacturing ANDA's with the installation of new equipment that could be used exclusively by pharmaceutical research and development.
• Developed several new technology platforms to better enable scientists to develop and manufacture new formulations.
• Interacted globally with other heads of development within the company to collaborate and solve problems with formulation and developing new technologies.
• Interacted with cross functional teams on all projects, acting as a team leader and a team member on many of the projects.
• Worked directly with process engineering and manufacturing during scale up of all processes to ensure that new technologies could be integrated into the existing infrastructure.
• Interacted with business development on a consultant basis to find new technologies and outsourcing contract formulation development and contract manufacturing of new products.
• Acted within a cross functional team of management to increase efficiency of the development of new formulations in pharmaceutical research and development and not decrease the efficiency of the regular manufacturing processes.

Schwarz Pharma Mfg., Inc., Seymour, IN, Manager Product Development, 1992 - 2000

• Key management position answering to Director of Pharmaceutical Development.
• Responsible for the setting up of the new Product Development Department of this growing company.
• Directed scientists in formulating new drugs using extended and sustained release technology. Instrumental in the reorganization and implementation of a Clinical Supply Department.
• Supervised scientists and technicians in the development and scale up and transfer of several solid and semi-solid formulations.
• Participated as a member of the Clinical Protocol Review committee for NDA's.
• Advised management and implemented strategy to transfer new sustained release technology to our facility.
• Managed the development and technology transfer of several sustained release products, increasing our technology platforms within our own facility thereby relieving our company of dependence on outside contract manufacturers.
• Spearheaded the transfer of over 23 different manufactured products, including solid, semi - solid, liquid and suspension dosages from our facility in Milwaukee to our new acquisition in Indiana.
• Transferred numerous semi-solid products from an acquisition in N.J. to our facility in Milwaukee and Indiana.

Additional Professional Experience

• Biocraft Laboratories, Mexico, MO, Manager Quality Control
• Pharmaceutical Delivery Systems, St. Louis, MO, Manager Technical Services
• Petrolite Corporation, St. Louis, MO, Formulation Development, Research Chemist
• Norcliff-Thayer, St. Louis, MO, Chemist
• Adolph Coors Brewery, Golden, CO, Chemist