Sr. Director, Quality Systems and Compliance, Antigenics, Inc.
Lexington, MA

• Responsible for integrating and directing all aspects of the company's GMP and GCP quality programs, including:
  
  • Managing the company's Quality Assurance functions including Validation/Calibration, Documentation, Training, Auditing and general Quality operations
    
  • Managing Quality Control including Microbiology, Analytical Testing and Raw Materials/Stability Programs
    
  • Participating in strategic cross-functional project teams to advance programs from pre-clinical to clinical and to advance partnering opportunities, supply agreements, etc.
    
  • Participating in corporate and functional goal setting and implementation
    
  • Managing 3 Associate Directors and combined staff of 20 employees

Director, Quality Assurance, Antigenics, Inc.
Lexington, MA

• Responsible for directing all Quality Assurance functions including:
  
  • Developing, implementing and maintaining all necessary Quality Systems for GMP compliance under 21 CFR Part 210-211
    
  • Establishing and implementing a vendor audit/vendor qualification program
    
  • Providing quality/regulatory input for the design and build-out of Antigenics current facility
    
  • Participating in Type C meeting with FDA to present design of GMP suites
    
  • Developing validation strategies/master plans for facilities, equipment and processes and fully executing validation efforts to assure PLI readiness.
    
  • Providing CMC support for IND filings, annual reports, master file updates, etc. for company's biologic, pharmaceutical and adjuvant programs.
    
  • Successfully leading the company through its first FDA inspection
    
  • Establishing formal mechanism for trending and review of quality data
    
  • Participating in strategic cross-functional project teams to advance programs from pre-clinical to clinical and to advance potential partnering opportunities.
    
  • Overseeing contract manufacturing organizations during production of pharmaceutical and adjuvant products
    
  • Implementing a company-wide training program
    
  • Managing 3 Managers and combined staff of 12 employees

Director, Regulatory Affairs, Aquila Biopharmaceuticals, Inc. (Acquired by Antigenics, Inc. in 2000), Framingham/Woburn, MA

• Responsible for directing regulatory and compliance functions, including:
  
  • Defining and executing Regulatory strategies for multiple products including vaccines, recombinant proteins, biological constituent material, etc.
    
  • Directing, preparing and reviewing INDs and related submissions (annual reports, safety reports)
    
  • Preparing, maintaining and updating clinical and manufacturing Biologics Master Files
    
  • Providing direct support to clinical studies by assisting in the preparation and review of all clinical trial documents including Protocols, CRFs, Clinical Study Reports and Investigator's Brochures
    
  • Interfacing with local, State and Federal regulatory agencies and assuring compliance with regulations and guidelines
    
  • Providing regulatory support to multiple pharmaceutical partners
    
  • Participating in cross-functional project teams
    
  • Reviewing and approving GMP-related documentation, including manufacturing documents, product labels, QC documents and validation documents
    
  • Securing and maintaining product and establishment licenses for veterinary biologics
    
  • Supervising two Managers and two Associates

Acting QA Director, Aquila Biopharmaceuticals, Inc. (Acquired by Antigenics, Inc. in 2000), Framingham/Woburn, MA

• In addition to Regulatory duties described above, provided Quality Assurance leadership during a transitional period following a merger. Responsibilities included:
  
  • Reviewing manufacturing and quality control batch history records and dispositioning lots accordingly
    
  • Performing internal and external GMP compliance audits
    
  • Providing GMP training
    
  • Supervising and training QA Associates and Documentation Specialists
    
  • Overseeing quality systems such as deviation process, OOS investigations, etc.

Senior Manager, Regulatory Affairs, Behring Diagnostics, Inc. (formerly PB Diagnostics), Westwood, MA.

• Additional managerial responsibilities with this promotion included:
  
  • Managing a staff of five persons
    
  • Participating in mergers and acquisitions
    
  • Developing world-wide quality and regulatory policy
    
  • Managing FDA and related government inspections

Manager, Regulatory Affairs, PB Diagnostic Systems, Inc.
Westwood, MA

• Responsibilities included:
  
  • Strategic planning and preparation of 510(k)s and PMAs
    
  • Reviewing, approving and implementing product labeling
    
  • Preparing registration packages for international regulatory submissions (Japan, Canada, Germany)
    
  • Assisting in the preparation of ELAs and PLAs
    
  • Obtaining 801(e)s, Certificates for Export and Drug Export Permits
    
  • Overseeing the product transfer process for multiple products
    
  • Maintaining and auditing federal, state and local compliance activities (USDA, NRC, DEA, MWRA, etc.)
    
  • Reviewing and approving manufacturing and GMP related documentation
    
  • Conducting GMP and ISO related audits
    
  • Evaluating and reporting MDRs and coordinating and directing product recalls and field corrections
    

Regulatory Associate II, PB Diagnostic Systems, Inc.
Westwood, MA

• Responsibilities included:
  
  • Preparing 510(k) submissions
    
  • Creating and reviewing product labeling
    
  • Maintaining licenses and permits for various compliance programs

Supervisor, Regulatory Compliance, Boston Scientific Corp.
Watertown, MA

• Promoted to this position during a four subsidiary merger. Responsibilities included:
  
  • Monitoring and trending customer complaint activity
    
  • Evaluating, documenting and reporting MDRs
    
  • Coordinating and executing product recalls
    
  • Conducting GMP audits
    
  • Assisting corporate legal department with product liability issues
    
  • Preparing 510(k) submissions
    
  • Supervising a staff of four persons

Administrative Supervisor, Customer Service, Microvasive, Inc.
Milford, MA

• Responsibilities included:
  
  • Processing, evaluating and trending customer complaints
    
  • Overseeing on-line order entry and customer support functions
    
  • Training and supervising a staff of six persons
    

INSTRUCTOR

Becker College, Worcester, MA
Fall Semester, 1996

Instructor for a three-credit course entitled GMP/Quality Assurance (21 CFR Part 210 and 211) for the Biotechnology Certificate Program.