Independent Consultant, Hingham, MA

• Independent consultant in the fields of therapeutic immune globulins, human plasma proteins, fibrinogen and platelet clotting, blood products, bio-separations, and bioreactor culture for monoclonal antibody manufacture.

Assistant Director, Massachusetts Biologic Laboratories (MBL), Worchester, MA.

• MBL is a FDA licensed vaccine, therapeutic plasma proteins and therapeutic immune globulin manufacturing facility.
  

Director of Plasma Protein Fractionation Laboratory, Therapeutic Immune globulin Research and Development and Bacterial Conjugate Vaccine Research and Development.

• Responsible for the research, development, and production of human plasma protein products
  Duties include supervision of twenty-six scientists covering a 24 hour rotational shift schedule
  Responsible for intradepartmental total quality management, quality assurance, and in-process quality control testing for manufacture
  • The FDA GMP production laboratory processes 300,000 liters of human plasma per year for manufacture of iv. immune globulin, im. immune globulin and albumin products
  • Responsibilities include writing the product development, process validation, viral clearance validation, and manufacturing CMC sections of IND, PLA, and ELA documents
• Developed a new process technology for manufacture of hyper immune intravenous immune globulins, having native IgG structure conformation
  • Success of this program lead to the implementation of Varicella Zoster Immune Globulin and the first USA licensed hyper immune intravenous immune globulin, CytoGam , and later the RSV immune globulin product Respigam
  • Other hyper immune IgG products continue to follow the implementation of this technology and the program is now the financial backbone of the laboratories
  • First to introduce solvent detergent viral inactivation for immune globulin products in 1984 and then nanofiltration viral removal filtration in 1998 to further ensure product safety
  • The high yield, intravenous immune globulin manufacturing process was successfully sub-licensed to three other USA FDA licensed laboratories
  • Responsibilities also included scientific liaison functions in technology transfer and due diligence evaluations for sub-license agreements.
• In 1992, served as project director to design, implement construction, and perform start-up validation to upgrade the Cohn/Oncley ethanol process GMP production facility
  • State of the art computer controlled automated equipment was installed to scale-up capacity five fold while essentially maintaining the same number of staff scientists
  • Batching, reagent addition, ethanol addition, temperature control, mixing, and equipment CIP is fully automated with batch record data recording
  • The laboratory can accommodate a capacity of 350,000 liters plasma throughput
  • The fully validated computer controlled facility served as a model establishing technology transfer agreements with four FDA licensed manufacturing facilities
  • The agreements are based on the use of process design concepts and equipment layout for facilities upgrade.
• Directed cell culture manufacturing efforts to establish a human monoclonal antibody (MABS) program for providing therapeutic monoclonal antibody products for certain categories of infectious diseases
  • The program is a logical extension of the hyper immune program
  • Duties included supervision of six scientist optimizing cell culture operations for 1000 liter volume bioreactor culture and manufacturing.
  • Responsible for product development, process validation, and manufacturing sections of IND, and ELA document preparation for three pipeline development monoclonal antibody products
  • Served as a scientific liaison for the technology transfer of MedImmune developed anti- RSV monoclonal antibody product Synergist to MBL
  • Provided input into the design of the bioreactor cell culture laboratory of a new 80 million dollar MBL manufacturing facility now under construction
• Responsible for the research, development and implementation of a program to produce a Hemophilus influenza type b (Hib) bacterial vaccine to protect newborn infants from disease
  • Success of the program included preparation of clinical lots of a purified polysaccharide Hib component chemically attached to a more immunogenic tetanus toxoid carrier protein
  • The conjugate technology was transferred, along with trained staff to the bacterial vaccine production laboratory for large lot production
• Principal investigator (1997-2001) for a WHO Grant to study the development of a single dose Tetanus toxoid vaccine
  
  • Efforts focused on the use PLGA microsphere technology to simultaneously encapsulate tetanus toxiod and adjuvants
  • Animal immunogenicity testing confirmed the validity of this approach and the combined microsphere technology is lead candidate for WHO/NIH directed clinical study

Assistant Director & Director of Quality Control - Quality Assurance - Regulatory Affairs Department, Massachusetts Biologic Laboratories (MBL), Worcester, MA.

• In response to revised FDA guidelines for pharmaceutical facilities, I was asked to set up and direct a separate division of quality assurance, quality control, and regulatory affairs
• Quality control operations from each of the four manufacturing departments were centralized
• Responsible for Quality control testing of bacterial vaccines, plasma protein products, and laboratory environment
• Set up a new Quality Control Laboratory and implemented guidelines for new CFR GMP practices
• Conducted Good Manufacturing Practices meetings and training sessions
• Prepared FDA license updates for existing products and license applications for new products
• Prepared establishment license for new laboratory facilities
• Supervised eight Quality Control Department scientists and coordinated quality control activities for three production departments
• Served in the highly visible position as company liaison to coordinate all Federal FDA interactions
  

Associate Scientist, Center for Blood Research, Boston, MA.

• Co-investigator, NIH grant for research on purification methods for recovery of trace plasma proteins of clinical use in replacement therapy

Chemist (1/2 Time), Massachusetts Biologic Laboratories (MBL), Worcester, MA.

• Set up new analytical procedures to measure purity of immune globulins and developed methods to improve purity and eliminate the propensity of immune globulins to aggregate and fragment.
• Part time position while attending graduate school.
  

Bacteriologist, Massachusetts Biologic Laboratories (MBL), Worcester, MA.

• Within the bacteria vaccine department performed bacterial culture and fermentation experiments with enteric pathogens.
• The research group discovered that Shigella diseases had an enterotoxin component.
• Performed protein purification and characterization of Shigella and Cholera enterotoxins.
• Participated in bacterial vaccine production and testing.
• Introduced semi-continuous culture fermentation.