Principal Consultant
MFD & ASSOCIATES, Melrose, MA (2005 - Present)
CONSULTANT
HYALURON, INC., BURLINGTON, MA (2004 – 2005)
VICE PRESIDENT OF QUALITY/ENGINEERING: Overall responsibility for Hyaluron’s
Quality Assurance and Engineering Development activities. Also responsible for
validation activities to ensure compliance of new equipment and processes.
Interacted with all company departments on Quality and Engineering related issues
and set long term and short term quality goals and objectives to ensure company
compliance with U.S. FDA drug CGMP’s and device Part 820 Quality System
Regulations, including ISO 9001:2000 and ISO 13485.
FORMATECH, INC., ANDOVER, MA (1999 – 2003)
DIRECTOR OF OPERATIONS: Responsible for the design and construction of
Formatech’s a multi-million dollar contract aseptic fill clinical supply facility.
Performed on-site coordination between the engineering design teams and
construction groups during construction. Executed the start-up, commissioning,
and validation of the facility. Responsible for all manufacturing operations including
formulation, aseptic filling, lyophilization, labeling, and packaging including the
facilities/engineering group. Also, assisted in developing marketing and sales
strategies and providing technical sales support.
BIOMETICS, INC., WALTHAM, MA (1993 – 1999)
VICE PRESIDENT OF VALIDATION SERVICES: (1998 -1999): Responsible for national
and international marketing/sales and validation services including regulatory
compliance and quality assurance consulting.
DIRECTOR OF VALIDATION SERVICES: (1996 -1997): Responsible for validation
services and regulatory compliance/quality assurance consulting.
VALIDATION MANAGER: (1993 – 1994): Responsible for validation services and
regulatory compliance/quality assurance consulting.
IMMUNOGEN, INC., NORWOOD, MA (1994 –1995)
VALIDATION MANAGER: Responsible for Implementing and coordinating the
validation of all facilities, utilities, equipment, and processes used in the
manufacturing of GMP recombinant, conjugated antibodies.
C. R. BARD, USCI DIVISION, BILLERICA, MA (1992 –1993)
VALIDATION MANAGER: Responsible for supervising and coordinating the
validation of all facilities, utilities, equipment, and processes used in the
manufacturing of angiographic medical catheters and implants.
BIOGEN, INC., CAMBRIDGE, MA (1983 –1992)
VALIDATION MANAGER (1990-1992): Responsible for supervising the validation of all
equipment and utility systems used in manufacturing of biotech-derived biologicals
MANAGER OF DRUG FINISHING OPERATIONS/VALIDATION (1987-1990): Responsible
for supervising and coordinating the filling, packaging, and distribution of all
biopharmaceuticals and the implementation of a new validation program.
MANAGER OF DRUG FINISHING OPERATIONS (1983-1987): Responsible for the start-
up of a new aseptic fill/finish facility including the purchase and installation of
equipment. Supervised the filling and finishing of all parenteral drugs needed for
clinical trials.
DAMON BIOTECH, NEEDHAM, MA (1982 –1983)
QUALITY ASSURANCE MANAGER: Responsible for developing and implementing
quality assurance and quality control procedures for raw materials, in-process
material, and pharmaceutical bulk product.
BIOLOGIC LABORATORIES, BOSTON, MA (1970 –1982)
CHIEF OF QUALITY CONTROL (1980 -1982): Responsible for the quality control
testing of all commercial biologicals including analytical, chemical, and animal
potency assays
SUPERVISOR OF FILLING AND DISTRIBUTION (1974 -1980): Responsible for
supervised the filling, finishing, and distribution of 16 licensed parenteral drug
products (blood derivatives and bacterial vaccines).
MICROBIOLOGIST: (1970 -1973): Responsible for performing USP sterility tests on all
bulk and final drug products and assisting in the development of new potency
assays.
U.S. ARMY – U.S. ARMY HOSPITAL, FT. CARSON, CO (1968 –1970)
MICROBIOLOGIST: Worked in areas of diagnostic bacteriology, parasitology, and
mycology.
EDUCATION
Northeastern University, Boston, MA, 1968 B.A., Biology; Minor: Chemistry
PROFESSIONAL ORGANIZATIONS
ISPE: Founding member of local Boston Area Chapter); former Board member and
Treasurer
PDA: Member, New England Chapter, President-Elect 2003-2004, President 2005-
2006, Board Member-at-Large 2007
