- Ph.D. Chemical Engineer with extensive experience and demonstrated success in the design and development of devices, drug delivery systems and manufacturing processes for the biotechnology, medical device and pharmaceutical industries.
- Process science/engineering, material science, solid state characterization, polymers, membrane separations, surface and interfacial science, emulsions/suspensions, drying, particle technology, in vivo PK testing, design of experiments (DOE), technical writing, project management, regulatory submissions, and patent consultation.
Undisclosed Company, 2008 - Present
- A private biopharmaceutical company focused on the development of novel, nanotechnology-based therapeutics in the areas of oncology, cardiovascular, autoimmune and inflammatory diseases.
- Lead company efforts in the development of process platforms for making drug-loaded nanoparticles, provide technical guidance on formulation development and mentor junior level scientists.
- Developed semi-continuous process for making nanoparticles.
- Designed proprietary nanoparticle generator.
- Led CMC development team for company's first nanoparticle product.
Alermes, Inc, Cambridge, MA, 1991 - 2008
- Positions filled: Research Fellow (Associate Director), Sr. Staff Scientist, Sr. Engineer
- A biotech company focused on developing and manufacturing controlled drug delivery products, including controlled release microsphere products made with biodegradable polymers.
- Responsible for directing technical project teams and maintaining client relationships in the development of microsphere products and processes.
- Identified advantageous areas of research and new technologies.
- Company expert on microsphere technology.
- Technical/Scientific Leader for the development of two commercial microsphere products including Risperdal Consta%uFFFF, $1 billion controlled release antipsychotic.
- Developed two proprietary microsphere process platforms.
- Guided batch size scale-up efforts from gms to 10's of kgs.
- Developed novel and proprietary microencapsulation method using non-toxic solvents.
- Developed proprietary extraction procedure to reduce residual solvents in product.
- Developed 4-week line extension formulation of current 2-week Risperdal Consta%uFFFF.
- Authored pharmaceutical development sections of NDA.
- Led efforts to improve scientific understanding of microsphere drug delivery technology by exploring alternate characterization techniques, developing original performance tests and soliciting external collaborations.
- Led teams to investigate causes and identify corrective measures for a number of technical issues including: injectability failures, poor powder flow ability, variable drug release behavior, and poor product stability.
- Developed numerous other controlled release formulations including a contraceptive, hormone for cancer therapy, and an HIV vaccine. Processes were scaled-up from laboratory to clinical trial scale for clinical evaluation.
- Consulted as Technical Expert for company patent defense and opposition cases.
- Compiled over 20 patents.
DuPont Company, Extracorporeal Therapy Group, Wilmington, DE, 1981 - 1990
- As Product Engineering Supervisor and Senior Biomedical Engineer of an internal DuPont business venture focused on the development of extracorporeal blood treatment systems.
- Managed engineer and 2 technicians. Coordinated internal research and external contract projects for instrument design, consumable manufacture, and sterilization.
- Developed therapeutic plasmapheresis system. Developed novel technique to improve plasma separation.
- Guided $2 million program to design and construct prototype disposables and instrument.
- Designed and developed immunosorbent columns for therapeutic depletion of specific blood pathogens.
- Identified critical need and supplier of automatic regeneration instrument resulting in joint development agreement and acceleration of program by 2 years.
- Developed product specification for second generation instrument answering customer demands of increased utility and less manpower and launching a $1.2 million instrument development program.
- Developed and designed second generation column reducing critical raw material component by 40% and cutting unit costs by 70%.
Johnson & Johnson Co, King of Prussia, PA and New Brunswick, NJ, 1978 - 1981
- J&J subsidiaries focused on developing, manufacturing and marketing cardiovascular surgical products.
Senior Research Scientist
- Managed device development laboratory including supervision of three technicians.
- Developed product specifications and manufacturing processes.
- Conducted in-house laboratory and external animal product tests.
- Participated in the design and development of innovative membrane oxygenator. Novel to the design was the use of secondary flows to improve gas transfer rates.
- Assisted in the design and development of ancillary cardiovascular products: venous reservoir, arterial blood filter, cardiotomy reservoir, and tubing sets.
Honors & Publications
Academic and Professional Affiliations
- American Association of Pharmaceutical Scientists
- Controlled Release Society
Publications and Patents
- Author and Co-Author, journal, posters, and abstracts.
- Over 25 patents.
- Ph.D. Chemical Engineering, Northwestern University, Evanston, IL
- M.S. Biomedical Engineering, Northwestern University, Evanston, IL
- B.S. Mechanical Engineering, University of Notre Dame, Notre Dame, IN