MFD & ASSOCIATES, Melrose, MA (March 2005 – to present)

PRINCIPAL CONSULTANT

Responsible for 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 development and execution

• Development of Master Validation Plans

• Aseptic Process Validation

• Vendor/contract quality audits

• Development of risk assessments and remediation of deviations and CAPA events

• Development of validation, metrology, and preventive maintenance programs

• Writing equipment and utility standard operating procedures

• European and US regulatory requirements for downstream processing

Lyophilization Services of New England, Inc. (LSNE), Bedford, NH

(April 2011 to 2012): Provided consulting services for a newly renovated, dedicated, aseptic fill facility, in the areas of quality systems, water and HVAC validation, final product visual inspection, and facility environmental monitoring in preparation for a FDA PAI for a sterile injectable cytotoxic drug.

(May 2010 – March 2011): Hired as Senior Vice President of Quality Systems/Engineering: Responsible for Quality activities at three (3) LSNE facilities. Responsible for the implementation of QA, QC, and validation procedures and programs needed to support CGMP medical device and aseptic drug manufacturing operations.

(2006 – 2010): Provided QA consulting services to LSNE’s for their recently built aseptic fill drug facility located at 19 Harvey Road, Bedford, NH. Provided technical assistance to existing staff for the development and expansion of CGMP QA and QC procedures and programs. Also assisted in the development and execution of validation protocols for critical utility systems and support equipment. Assisted QA/QC staff in preparations for a successful PAI and compliance inspection for a sterile injectable drug which was successfully accomplished in September 2009. Assisted in the process validation of several sterile injectable products manufactured for clients. Played a key role in the start-up operations at LSNE’s newly built multi-product, medical device/drug contract manufacturing facility located at 25 Commerce Drive, Bedford, NH. Played a key role in the development of QA, QC, and validation protocols, procedures, and programs to support drug and medical device manufacturing operations. Assisted in hiring of QA and QC staff needed to staff the new facility.

MBL (Massachusetts Biological Laboratories), Jamaica Plain, MA

(Jan-July 2006): Provided consulting services in the areas of HVAC validation, aseptic processing, and environmental monitoring in the aseptic fill suite for a new, state-of-the-art, upstream/downstream vaccine manufacturing facility.  

HYALURON, INC., BURLINGTON, MA (2004 – 2005) (now called AMRI)

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 modular batch record system to streamline batch record development for client processes

• 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