MFD & Associates

MFD & ASSOCIATES, Melrose, MA (2005 – Present)

Principal Consultant  Providing validation, Quality, Compliance, and Manufacturing consulting to the biotechnology, pharmaceutical, and medical device industries. 

Specializing in:

Quality systems and programs
Facility, utility, and equipment validation protocol and execution
Development of Master Validation Plans
Vendor/contract quality audits
Development of validation, metrology, and preventive maintenance programs
Writing equipment and utility standard operating procedures
European and US regulatory requirements for downstream processing
Facility design and layouts

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.

Wrote Validation Master Plan for new CGMP Manufacturing Aseptic Fill Facility

• Initiated the validation of the new 5,500 sf CGMP Aseptic Manufacturing facility by writing facility and utility validation protocols and overseeing their execution  
• Implemented new format for standard operating procedures and forms to conform with current industry practices
• Implemented new procedures to address change control, out-of-specification results, and corrective and preventive actions

Reviewed all client contracts and proposals for quality compliance

Actively participated in client audits

Coordinated client engineering process technology transfers

Managed and coordinated metrology and preventive maintenance programs

Oversaw and managed all facility upgrades and improvements

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.  Also, assisted in developing marketing and sales strategies and providing technical sales support.

Performed the following initial start-up activities:

Wrote and implemented metrology and validation programs

Wrote Validation Master Plan for facility

Assisted in the development of Quality documentation system including quality SOPs and programs

• Hired and trained manufacturing staff
• Developed and wrote manufacturing operating procedures and master batch records
• Wrote and implemented preventive maintenance program

Other responsibilities include:

Supervised all contract aseptic fill/finish manufacturing operations, as well as for facilities/engineering, inventory control, and shipping/receiving activities

Developed weekly production schedules

Assisted in writing Standard Operating Procedures and batch records

Performed manufacturing technology transfers when required with clients or with Formatech’s development laboratory

Provided technical support to marketing/sales group

Actively participated in client audits

Operated, programmed, and maintained Formatech’s lyophilizer

Interacted with all fill/finish clients to provide technical expertise in resolving process issues and batch record conflicts

Oversaw all facility maintenance and metrology activities

Special project:

Initiated and completed the conceptual design study, with an outside engineering design firm, for a multi-million dollar build out of the current manufacturing facility.

BIOMETICS, INC., WALTHAM, MA (1996 – 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.

Increased validation revenues in 1999 by over 400%

Provided clients with technical assistance in their presentations before FDA.

Initiated company’s first process validation projects in Canada and the United States

• Manage and trained new validation engineers
• Provide liaison between company and clients for all projects
• Developed Quality Manual, SOPs and other supporting quality documentation for clients
• Provide overall project management for projects and actively participated in protocol development and field execution work
• Developed Validation Master Plans for new client facilities
• Assisted in the design of aseptic fill and biopharmaceutical facilities including upstream and downstream areas
• Presented current validation information and concepts at local and national trade and professional organizations

DIRECTOR OF VALIDATION SERVICES (1996 -1997): Responsible for validation services and regulatory compliance/quality assurance consulting. 

• Increased validation revenues by 50%
• Initiated company’s first training program for validation engineers
• Provided overall project management for all projects and actively participated in protocol development and field execution
• Initiated new databases to organize and track project work
• Developed Validation Master Plans for clients

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.

Managed, supervised, and trained engineers and manufacturing staff executing validation protocols

Developed facility and Process Validation Master Plan for Norwood, MA manufacturing facility

Initiated and implemented new standard formats for validation protocols to expedite their review and execution

Initiated development of new chromatography and assay validation protocols

Performed CGMP audits of raw material suppliers and contract filler        

BIOMETICS, INC., WALTHAM, MA (1993 –1994)

VALIDATION MANAGER:  Responsible for validation services and regulatory compliance/quality assurance consulting.

 Actively participated in protocol development and field execution work

 Assisted in the design of biopharmaceutical facilities

 Performed CGMP audits of client facilities and HVAC systems

 Managed and supervised a group of five (5) validation engineers and technicians

Developed Facility and Process Validation Master Plans for biopharmaceutical clients

Responsible for project management of all company validation projects

Presented current validation information and concepts at local and national trade and professional organizations (INTERPHEX, Tradeline, ISPE, American Society of Plumbing Engineers)

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.

Developed and implemented first comprehensive validation program for the Division

Implemented first computerized database system for tracking and monitoring the status of ongoing validation activities (Excel, Paradox)

Developed and performed validation training for Division management and manufacturing staff

Successfully completed process validation of two major product lines

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

Developed, supervised, and executed validation programs for fermentation and cell culture systems

Coordinated and supervised the calibration of all devices and instruments used in CGMP manufacturing operations

Successfully orchestrated all validation activities required following a 15 million-dollar renovation of production area and utility

systems

Developed a computerized tracking system for monitoring ongoing validation activities

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.

Developed and implemented company-wide validation program for all CGMP operations

Supervised the calibration of all critical devices and instruments used in production and support groups

Played a leading role in the design, construction, and start-up of a new fill and finish facility for Biogen's German subsidiary

Organized and participated in the successful technology transfer of a major product to Biogen's German subsidiary

Coordinated and supervised on-site training for the filling and lyophilization of a major biotech product at Biogen's German subsidiary

Initiated and fostered growth of Contract Fill business during 1988-89

Successfully negotiated contract fill agreements with biotech companies which generated substantial revenues for Biogen

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.

Developed procedures for all unit operations including component preparation, product filtration, filling, capping, visual inspection, labeling, and packaging

Successfully staffed (10 people) and trained personnel for start-up of newly constructed Aseptic Fill facility in preparation for clinical launch of first biotech product

Successfully manufactured 49 product lots in 1984 which enabled company to meet all clinical trial needs

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.

Implemented quality assurance and quality control procedures for developmental products such as monoclonal antibodies and other biologicals under development

Coordinated departmental planning and budgeting

Developed and implemented documentation control and quality control systems including all required Standard Operating Procedures

Initiated and administered quality improvement programs

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

Maintained master drug files and prepared and submitted product lot protocols to FDA for final lot release

Prepared and submitted IND amendments to FDA

Participated in over 20 FDA GMP inspections

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).

Prepared and distributed weekly, monthly, and annual product distribution reports

Designed all labeling for drugs; operated and repaired filling and labeling equipment

Designed and oversaw the construction of a new aseptic fill suite which allowed the company to meet increased production demands

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.

Developed and implemented environmental monitoring program for the aseptic filling facility

Assisted in the filling and distribution of commercial drug products

Assisted in the development of a new animal model for potency testing of  pneumococcal polysaccharide vaccine

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/CIVIC ORGANIZATIONS

ISPE: Founding Member of local Boston Area chapter; former Board Member and Treasurer

PDA: New England Chapter, former President, currently on Planning Committee; Global PDA: Co-Chair: Chapter Council

Mt. Hood Park Association: President

Melrose Symphony Orchestra: Board of Directors