Quality Assurance Control

DONALD J. PENNINO

** ***** ***** • Basking Ridge, New Jersey 07920 • Telephone: 908-***-**** (Home)

609-***-**** (Office)

609-***-**** (CELL)

OBJECTIVE

To obtain a senior level quality management role within a pharmaceutical or biotechnology company where I can utilize my technical background and professional experience gained to make a significant contribution to the organization’s overall objectives.

SUMMARY

• Over 30 years total professional experience in the pharmaceutical, medical device, vaccine and biotechnology industries.

• Over 20 years total management experience. Direct departments with up to 6 managers and up to 100 people.

• Over 25 years QA, QC and Analytical R&D experience. Acting liaison with regulatory bodies on inspections and submissions and oversee Clinical QA compliance programs.

• Accomplished in Project Management, Budget Planning, Quality and Process Improvements, and Technology Transfers as they relate to all cGxP activities.

• Excellent team player and mentor. Works well with management, vendors and production personnel,

• Ready to relocate and travel extensively if required.

EDUCATION

CITY COLLEGE OF NEW YORK, NEW YORK, NEW YORK

BS in Chemistry (1973)

Minor: MATHEMATICS

LONG ISLAND UNIVERSITY, BROOKLYN, NEW YORK

MS in Analytical Chemistry (1978)

Thesis: "A NOVEL FLUORIMETRIC ASSAY FOR ANDROSTERONE DERIVATIVES"

STEVENS INSTITUTE OF TECHNOLOGY, HOBOKEN, NEW JERSEY

Ph.D. in Physical Chemistry (1986)

Dissertation:"SOLVENT SHIFTS AND REACTION FIELD EFFECTS IN NUCLEAR MAGNETIC RESONANCE"

EXPERIENCE

CELATOR, PHARMACEUTICALS, INC.

Princeton, New Jersey

Sr. Director Quality Control/Quality Assurance, (12/05- Present)

Responsible for the Quality Unit operations that includes quality assurance, quality control and clinical compliance activities. Department has overall responsibility for release of raw materials, bulk drug substance

EXPERIENCE (CONTINUED)

and finished products , analytical method development , validations and managing the stability program. Lead all corporate quality programs and policies and Head the Quality Council. Perform clinical audits and

maintain site monitoring program, manage CRMs and CROs, as well as administering vendor qualification programs, trending analysis and CAPA initiatives.

CHIRON CORP, INC ./ NOVARTIS PHARMACEUTICALS, INC.

Annandale, New Jersey

Director QC and Analytical Development, (11/03-12/05)

Oversee technical operations for QC and Analytical Methods Development and Stability Department. Department has overall responsibility for release of raw materials, bulk drug substance and finished products as well analytical method development and validations. Support new product development, stability studies of both clinical and commercial products for biopharmaceutical division of the company. Provide guidance in developing PAT initiatives and in technology transfers to other sites. In addition to giving overall direction to the technical staff, responsibility includes maintaining relationships with API and raw material vendors, contract laboratories and other outsourcing entities as required. Principal representative and contact for facilitating and hosting local FDA audits and inspections. Head the computer and analytical laboratory systems committee for the Annandale, NJ facility operations.

RCM TECHNOLOGIES, INC.

Parsippany, New Jersey

Validation Manager, (2/02-11/03)

Acting as Project Manager for consulting firm specializing in computer systems validation. Most clients are major pharmaceutical companies that require validation services including gap analysis on systems that need assessment of compliance to 21CFR Part 11. Services also include software vendor audits, quality assurance support and full IQ/OQ/PQ on new and legacy systems. Computer systems include manufacturing and packaging equipment, analytical instrumentation and clinical applications in the pharmaceutical, biotechnology and medical device industries.

STRYKER BIOTECH, INC.

Hopkinton, Massachusetts

Director of Quality Control/Quality Assurance, (12/00-2/02)

Responsible for the overall management and daily operation of the quality control and quality assurance departments consisting of a technical staff of 40. Additional duties include project planning and management for the manufacturing operations of the facility , process and equipment validations (IQ/PQ/OQ), release of raw materials and the finished osteogenic protein product (OP-1) as well as capital and budget implementation throughout the fiscal year.

DURAMED PHARMACEUTICALS, INC.

Somerset, New Jersey

Director of Quality Control/Quality Assurance, (12/98-12/00)

Responsible for the overall management and daily operation of the quality control and quality assurance departments consisting of a technical staff of 20. Additional duties include project planning and management for the manufacturing operations of the facility , process validation, release of raw materials and finished goods as well as capital and budget implementation throughout the fiscal year.

EXPERIENCE (CONTINUED)

WARNER-LAMBERT

PARKE-DAVIS DIVISION

Morris Plains, New Jersey

Sr. Research Associate, (7/93-12/98)

Group Leader responsible for the direct supervision of 8 chemists involved in the development and validation of analytical methods for pharmaceuticals. Duties include writing technical reports and documents for submission into IND's, ANDA's and NDA's.

SCHERING-PLOUGH RESEARCH INSTITUTE

Kenilworth, New Jersey

Principal Scientist, (6/88-7/93)

Group Leader responsible for the direct supervision of 6 chemists involved in the development and validation of analytical methods for biopharmaceuticals and protein products. Duties include writing technical reports and documents for submission into IND's, PLA's and NDA's. Duties also included supporting stability studies related to these pharmaceutical products and writing final reports.

CONNAUGHT LABORATORIES

Swiftwater, Pennsylvania

QC Manager, (5/87-6/88)

Responsible for the daily activities of the quality control department involved in the release testing of vaccines and related biological products. Duties included overall supervision of the chemistry, microbiology, serology, sterility and in-vivo quality control testing laboratories as well as final review and approval of batch records. The Quality Control Department was comprised of 35 people at that time. Other responsibilities included meetings and discussions with CBER branch of FDA on the development of new products leading to PLA submissions.

BOC GROUP TECHNICAL CENTER

Murray Hill, New Jersey

Senior Chemist, (1/81-5/87)

Spectroscopist in corporate analytical service group responsible for supporting projects and related technical problems of company. In this position I established a state-of-the-art high resolution FTNMR laboratory for the analysis of solution, solid-state and composite materials. Other techniques included FTIR (DRIFT and microspectroscopy), X-ray ( fluorescence, single crystal and diffraction) and molecular modeling studies as well as mass spectroscopy.

CR BARD, INC.

Murray Hill, New Jersey

QC/QA Manager, (11/79-1/81)

Duties included the direct supervision of 6 chemists involved in the release testing of generic pharmaceuticals (benzalkonium chloride, povidone iodine, barium sulfate, USP) as well as other diagnostic reagent kits. Responsibilities also included the monitoring of ethylene oxide residuals used in the sterilization of plastic medical device products.

EXPERIENCE (CONTINUED)

CIBA-GEIGY PHARMACEUTICALS

Suffern, New York

Associate Scientist, (11/74-11/79)

Analytical research chemist involved in the testing of investigational drug substances for use in clinical and toxicological studies. Analytical techniques used for establishing purity and monitoring for degradation of the drug substance includes HPLC, DSC, mass spectroscopy, NMR and titrimetic analysis.

MONSANTO FLAVOR/ESSENCE, INC.

New York, New York

Lab Technician, (6/73-11/74)

Responsible for the preparation of water/oil emulsions that were introduced into a unique spray-drying process. This process was successful in encapsulating and stabilizing otherwise volatile essential oils used in the flavor and fragrance industry. I operated a pilot plant equipped with two of these spray-dryers.

SKILL SET

• STRONG ORAL AND WRITTEN COMMUNICATIVE SKILLS. ESTABLISHED HIGH QUALITY EMPLOYEE TRAINING PROGRAMS. EFFECTIVE PROJECT MANAGER.

• CONDUCTED AND HAVE PARTICIPATED IN SEVERAL SUCCESSFUL FDA AND INTERNATIONAL AGENCY PRE-APPROVAL , BIENNIAL , QSIT AND ISO TYPE INSPECTIONS. HAVE ATTENDED VARIOUS PRE-NDA MEETINGS WITH THE AGENCY AND HAVE RESPONDED TO TECHNICAL QUESTIONS RELATED TO THE CMC SECTION OF THE SUBMISSIONS. HAVE BEEN INVOLVED WITH PRODUCT RECALLS AND HANLDING PRODUCT AND CUSTOMER COMPLAINTS. HAVE PERFORMED BOTH INTERNAL AND EXTERNAL QUALITY AUDITS REGARDING MANUFACTURE AND TESTING OF PHARMACEUTICAL PRODUCTS. HAVE WIRTTEN QUALITY MANUALS FOR BIOTECH , PHARMACEUTICAL AND MEDICAL DEVICE MANUFACTURERS.

• HAVE SERVED ON VARIOUS PROJECT TEAMS AT DIFFERENT PRODUCT DEVELOPMENT LEVELS RANGING FROM PRE-IND TO NDA STAGES. HAVE SUPPORTED AND BEEN INVOLVED AT THE TEAM DECISION LEVEL IN THE SUCESSFUL DEVELOPMENT AND LAUNCH OF MAJOR PHARMACEUTICAL PRODUCTS SUCH AS INTRON, PEG-INTRON, NEUROTIN, LIPITOR, REZULIN, LOESTRIN, CENESTRIN, PROCANAMIDE, OMNICEF, CLARITIN, RITALIN, TEGRETOL AND OP-1. SUPPORTED THE DEVELOPMENT FOR NATURAL PROTEIN BASED DRUG PRODUCTS (INTERFERONS, INTERLEUKINS, GMCSF, VEGF, BMP), RECOMBINANT PRODUCTS (CALCITONIN, PERTUSSIS VACCINE), VECTOR DELIVERY SYSTEMS( MODIFIED ADENOVIRUS), VACCINES (DPT, MENINGICOCCAL, HEMOPHILUS INFLUENZA-DIPTHERIA CONJUGATE, INFLUENZA, YELLOW FEVER)

• WELL TRAINED IN ALL AREAS OF ASEPTIC, SOLID ORAL, SEMISOLIDS, AND LIQUID DOSAGE FORMS. STRONG EXPERIENCE IN THE DEVELOPMENT OF VACCINES AND MEDICAL DEVICES, WITH SPECIAL EMPHASIS ON DESIGN CONTROL.

• HAVE DEVELOPED VALIDATION MASTER PLANS FOR FACILITIES INVOLVED IN THE MANUFACTURE OF ASEPTIC PRODUCTS, INCLUDING PARENTERALS, STERILE LYOPHILIZED POWDERS AS WELL AS VACCINES. HAVE QUALIFIED (IQ/OQ/PQ) AND COMMISSIONED FACILITIES, UTILITIES AND EQUIPMENT, INCLUDING COMPUTER VALIDATION FOR PART 11 COMPLIANCE.

SKILL SET (CONTINUED)

• VALIDATED MANUFACTURING PROCESSES INCLUDING, HEAT STERILIZATION, LYOPHILIZATION, STERILE FILLING, MEDIA FILLS, PACKAGING LINES AND SHIPPING PROCEDURES. WRITE SOPS FOR BOTH MANUFACTURING AND QUALITY UNITS. DEVELOP AND MAINTAIN CALIBRATION AND PREVENTATIVE MAINTENANCE PROGRAMS FOR VARIOUS SITES. RESPONSIBLE FOR IMPLEMENTATION OF ENVIRONMENTAL MONITORING PROGRAMS WHICH SUPPORTED CRITICAL ASEPTIC MANUFACTURING AREAS.

• EXPERIENCED IN LAB MANAGEMENT INCLUDING BUDGET PLANNING, TECHNICAL STAFF PERFORMANCE REVIEWS, CAPITAL APPROPRIAATION AND GENERAL RESOURCE PLANNING . HAVE SUCCESSFULLY DESIGNED AND CONSTRUCTED TO COMPLETION MANY FACILITY PROJECTS, INCLUDING LABORATORIES, CLEAN ROOMS AND CONTAINMENT AREAS.

• COMPUTER LITERATE ON PC'S, MINI AND MAINFRAME SYSTEMS. EXTENSIVE SCIENTIFIC PROGRAMMING EXPERIENCE. FLUENT IN FORTRAN , BASIC AND HTML PROGRAMMING LANGUAGES, INCLUDING WEBSITE DEVELOPMENT. HAVE MICROSOFT CERTIFICATION (MSCE) IN NT 4.0 SYSTEM NETWORK ENGINEERING.

• EXPERIENCED AND ACCOMPLISHED PRACTITIONER OF CGLP'S AND CGMP'S AS THEY RELATE IN THE PHARMACEUTICAL LABORATORY. EXPERT IN VALIDATION AND QUALIFICATION ISSUES IN BOTH LABORATORY AND PRODUCTION ENVIRONMENTS. HAVE INSTITUTED NEW QUALITY SYSTEMS INTO ORGANIZATIONS AS WELL REMEDIATION COMPLIANCE PROGRAMS RESULTING FROM 483 OBSERVATIONS AND OVERALL DEFICIENCIES AT BOTH THE QUALITY DEPARTMENT AND CORPORATE LEVELS. OVERSEE AND MANAGED QUALITY ASSURANCE GROUPS RESPONSIBLE FOR PRODUCT NON- COMFORMANCE, CAPA AND CHANGE CONTROL FUNCTIONS. RESPONSIBLE FOR FINAL PRODUCT BATCH REVIEW AND RELEASE DISPOSITION OF BOTH ASPETIC AND NON-STERILE PRODUCTS. COORDINATE AND OVERSEE CONTRACT LABORATORIES, MANUFACTURING AND OUTSIDE VENDORS, INCLUDING ESTABLISHING AND MAINTAINING SUPPLIER QUALIFICATION PROGRAMS.

• STRONG TECHNICAL BACKGROUND IN PHARMACEUTICAL ANALYSIS TECHNIQUES INCLUDE CHROMATOGRAPHIC METHODS DEVELOPMENT (GC AND HPLC ). STRUCTURE ELUCIDATION BY MASS SPECTROSCOPY, 2 & 3D MULTINUCLEAR FTNMR, AND X-RAY CRYSTALLOGRAPHY. OTHER TECHNIQUES INCLUDE FLUORIMETRY, THERMAL ANALYSIS, ATOMIC ABSORPTION, ICP, TITRIMETRIC AND THERMAL ANALYSIS.

• SPECIALIST IN THE AREA OF PROTEIN ANALYSIS UTILIZING CZE, SDS-PAGE, ELISA, WESTERN BLOT, ISOELECTRIC FOCUSSING, AMINO ACID ANALYSIS AND PROTEIN SEQUENCING, CIRCULAR DICHROISM AND RAMAN SPECTROSCOPY.

PROFESSIONAL REFERENCES

• JOHN VADNAIS SEVA CONSULTING GROUP. 973-***-****

PRINCIPAL

• TERRY WILSON FORT ORANGE CONSULTING 908-***-****

PRINCIPAL

• JOSEPH DELUKEY CELGENE PHARMACEUTICALS 908-***-****

MANAGER, COMPLIANCE AUDITING

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