Quality Assurance, Validation

Peter W. Cardinal

*** ******* ****, *******, ** *2804

Phone: Cell 401-***-****

*************@*****.***

Education: BS University of Rhode Island Major: Microbiology

Seminars: Fill/Finish validation, Computer Validation, Process Validation, Facilities/Utilities Validation, Kaye Thermal Validation, Cleaning Validation, and PDA Steam Sterilization Scientific Forum

Document review in accordance with 21CFR Part 11 and GAMP requirements.

Computer Competency - Word, Microsoft Project, PowerPoint, Track Wise, Lims, and Excel.

Professional Organizations: Clinical Research Society, Parental Drug Association, ISPE

EMPLOYMENT SUMMARY:

I am a 28-year biopharmaceutical Quality Assurance/Validation professional with experience and expertise in inspection, compliance, auditing, validation, supervision, project management, and third party QA/validation oversight. My experience is with commercial/clinical drug substance/drug product manufacturing and vaccines and includes activities related upstream/downstream production and drug product fill finish for internal and external manufacturing. Throughout the twenty-eight years in the Biotechnology industry I have been responsible for and or participated as a team member for the following activities:

Contractor/ vendor auditing and qualification

Participation in and authoring of External/Internal audit programs

Change control committee member and facilitator

Deviation and CAPA triage teams

Authoring and review of various local and corporate SOP’s for QA, operations/facilities and validation.

Directed the validation activities for startup of a small vaccine company including laboratories from development through commercialization which led to an approved vaccine.

Expert in regulations (GMP/GLP/GDP)

Batch record review and clinical batch release as part of for bulk drug substance and QA/validation oversight of third party CMO’s.

Participation in and preparation for regulatory inspections including 4 PAI’s with the FDA and also inspections from EMEA and Canadian authorities

Authoring of applicable sections for BLA submissions

Managed the validation activities for start up of large cell culture facility including laboratories with up to 8 direct reports and oversight of up to 30 contractors which led to commercialization of an approved product

Oct 2012 to Present Quality Assurance Validation (Contractor)

Throughout this period, I have worked in the following capacities

At Moderna providing QA support for the Commissioning and Qualification (CQV) of a new facility in Norwood Ma. The support includes the review and approval of CQV related documentation (URS, Impact assessments, Risk assessments, protocols and reports. schedules.

At Alexion providing Clinical QA support for the manufacture of clinical trial Drug Substance and Drug Product executed at CMO’s. The support includes the review and approval of tech transfer documentation, work plans, master batch records, sample plans, equipment and process validation protocols and reports, stability plans and protocols, specifications, and analytical method validation. Participated in weekly and ad hoc meetings with CMO’s Batch release support included review and approval of executed batch records, deviations, change control, CAPAs, and OOS investigations and authoring of Batch disposition packages.

Employed at Allergan as a Technical Consultant reviewing validation system components and legacy documentation to provide guidance for gap assessment and potential remediation activities.

Employed with Foster Wheeler on a remediation project project participated in a detailed review and gap analysis project for legacy systems that included review of validation documentation, drawings, and SOPs. Authored trace matrices and where necessary IOQ protocols.

Employed with ICQ in Natick Ma on a global Takeda project as a team lead for two teams within the Vaccines Business Unit for FUME (Facilities, utilities, maintenance, engineering) and PPC (Production) The scope included generation of Global SOPs and process flows as well as cross functional/individual site SOPs where applicable. As part of that process assessments are provided assuring best practices and compliance with all applicable global regulatory requirements.

At Sanofi/Genzyme Allston, Ma facility worked as a QA/Validation consultant participated in a detailed review and gap analysis project for legacy systems that included review of validation documentation, drawings, and SOPs. Authored gap analysis reports and where necessary URS and criticality assessment documents. Participated in risk analysis of gaps and recommendation for remediation activities if warranted.

Working at Bristol Meyers Squibb (BMS) Devens, Ma facility as QA/Validation consultant in a detailed review and gap analysis project of process validation that includes BLA filings, batch records, SOP polices, tech transfer documents, and FDA inspections of 4 different BMS sites to provide gap analysis and potential remediation strategies where required.

Employed at Amgen (Woburn) supporting the authoring, preparation and execution of Drug product process validation to bring product to commercialization.

Employed at Genzyme (Allston Facility) supporting Commissioning and Qualification of facility expansion environmental monitoring project.

March 2009- to October 2012- Protein Sciences Corporation Meriden, Ct

Director of Validation

Oversee and execute validation activities IQ/OQ/PQ and Process Validation required to bring vaccine manufacturing facility from clinical manufacturing to commercial manufacture. Also, provided expertise and support to QA in establishing and maintaining Quality Systems (CAPA, Change Control, Deviations). Member and originator of the Change Control Committee. Responsibilities also include oversight of validation and QA requirements at CMO fill finish site. Participated in inspection readiness and was the host of one FDA PAI regulatory audits. Also, functioned as Project Manager for scale –up and commercialization of a new enzyme based product.

October 2007 to March 8 2009- Quality Assurance Validation (Contractor)

At Lonza Hopkinton working on contract to perform commissioning /validation activities which include IQ, OQ, PQ protocols and reports for equipment and utilities in support of expansion project for two additional manufacturing suites.

At Oxthera as consultant to support process validation project completion and documentation for filing and approval of new drug product.

At Pfizer as consultant to oversee the Quality function for validation activities related to lab and analytical instrumentation, support computer systems, support utilities, equipment, and facilities for research and development/clinical areas in Groton, Ct. Responsibilities include the QA review, oversight of GLP and GMP compliance, assessment, and approval of change control, incidents, CAPA, Temporary change records, validation plans, protocols, and reports. Worked within Track wise system for change control.

September 2002 to November 2007 - Amgen Inc. West Greenwich, RI

Validation Assoc. Manager/Senior Validation Engineer

Supported process validation function with prime responsibility of overseeing QA/validation at contract manufacturing sites to include oversight of validation of fill/finish, packaging, Lyophilization, and process validation.

Hire and oversee equipment/utilities validation function and provide support to third party contract validation groups for the startup and continued operation of a large mammalian cell culture biopharmaceutical facility.

Responsible for the review and approval of quality validation protocols and reports and the authoring of validation master plans. Also responsible for the review, approval, and assessment of Non-conformances, and change controls for the local site as well as global changes to the production process. Worked within Track wise system for change controls and deviations.

Initiated and executed the validation maintenance program, which includes system evaluation and periodic monitoring of critical processes.

Participated on various project teams representing validation for major process changes as well as shutdown and equipment change out projects.

Participate as a validation contact for internal and FDA/EMA/Canadian regulatory audits.

Responsible for the development of equipment/utility validation procedures and policies to assure compliance with Corporate, regulatory, and industry standards.

Sept. 1999 to Sept 2002. Wyeth Pharmaceuticals/Immunex/Amgen Inc. West Greenwich, RI

Validation Manager

Hire and oversee equipment, utility, computer validation function and provide support to third party contract validation groups for the startup and continued operation of a large mammalian cell culture biopharmaceutical facility. I was responsible for the review and approval of quality validation protocols and reports, non-conformances, user requirement specs, and change controls authored and executed/generated by third party contractors, Quality Control labs, and engineering department personnel. I was the main validation contact for all internal and FDA/EMEA regulatory audits. I was responsible for the development of validation procedures and policies to assure compliance with Corporate, regulatory, and industry standards.

June 1990 to Sept. 1999. WelGen / Burroughs Wellcome /Glaxo Wellcome Biopharmaceuticals Inc. West Greenwich, RI

Validation Specialist/Technical Services Specialist: (Jan.1992 - Sept 1999)

Responsible for the development and authoring of installation, operation and process qualification protocols for facilities, equipment, control systems and processes, execution of protocols and compilation of data into final summary reports. I was responsible for the purchase of equipment to support validation activities. Responsible for the review and approval of validation protocols and reports authored and executed by third party contractors, Production department, and Quality Control department personnel. I was responsible for hiring, supervising and training validation technicians. I participated in the establishment and maintenance of the Change Control program. I participated in regulatory and PAI audits with the FDA, MCA and Canadian regulatory authorities for the successful licensing of Wellferon.

Quality Assurance Auditor: (June 1990 - Dec. 1991): Responsibilities included: The development and implementation of external and internal audit procedures. Completed the initial audit and approval of all the vendors of raw materials and outside laboratory testing facilities necessary to facilitate start up of a large scale Mammalian cell culture facility and fermentation suite for the production of Wellferon.

June 1986 to June 1990 General Dynamics-Electric Boat Div. North Kingston, RI

Quality Auditor: Responsible for conducting internal audits of manufacturing and information management systems. The scopes of the audits included fabrication processes (piping, welding, and structural), coatings and vibration dampening systems, electrical shop activities, and MRP material computer system activities. Responsibilities included audit report generation and follow up.

June 1979 to June 1986 Stone & Webster Eng. Millstone III Nuclear Power Station Waterford, CT:

Senior QC Engineer: - Assigned as QA consultant with a team of QA Engineers to Sequoyah Nuclear Power station Chattanooga, Tenn. I assisted TVA staff in upgrading and developing Quality Assurance systems and documentation.

Senior Field Quality Control Engineer: Responsible for the supervision of (8-20) Second and Third Shift Quality Control personnel including structural, welding, electrical, piping, documentation, and warehouse inspection personnel. I was the Senior Site Quality Control representative during the off shift hours with the power of signature for the Site Quality Control Director.

Quality Assurance Associate: in the Quality Systems Div. Boston, MA. Responsible for the development and maintenance of quality assurance directives, standards and project QA manuals for various nuclear sites to assure compliance with Nuclear Regulatory commission requirements and other industry standards (ASME, AWS, ANSI, and ASTM).

Assistant Field QC Engineer: Responsible for the monitoring and inspection of structural steel fabrication, concrete, coatings, hangers/supports, and soils during initial construction phase of Millstone III Nuclear Power Station.

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