Medical Device Manufacturing

*** ********* *****, *** ** Washington, NJ, ***** 201-***-**** *********@*****.***

Motivated, with highly concentrated learning curve. Astute, and personable. Stamina and know-how to undertake the most challenging situation. Exceptional scientific experience with global Pharmaceutical, Medical Device and Biotechnology leaders. Projects include project management, auditing, training, method development, validation, stability testing, change control, specification and batch record preparation, Adverse Experience Reporting, label review and approval, Risk Management and Design Control. Excellent and effective planning, organizational, and interpersonal skills, excellent team player with an aptitude for sharing knowledge. Excellent written/spoken interpersonal communication and negotiation skills. Ability to guide, train, supervises and prioritizes workload of direct reports.

SPECIFIC EXPERTISE

• Authored regulatory CMC submission for the FDA, such as New Drug Application (NDA), New Animal Drug Application (NADA), Pre -Market Approval (PMA), 510(k), Biological License Application (BLA),

Marketing-Authorisation Application (MAA)and Labeling

• Develop regulatory strategies and guidance based on FDA Regulations (CFR 21, 211, 311, 500, 600, 800, 820, 1271), and International requirements as defined in, ISO 13485:2003 Standard Medical Device Directives, Canadian Medical Device Regulations, Japanese QMS, Australian Therapeutic Goods (Medical Device) Regulation and Brazil Medical Device Regulations (ANVISA)

• Prepared for Japan, the Sheihin hyoujun sho and Gaiyo documentation

• Strong knowledge of FDA, ISO, ICH, MDD and Active Cell Therapy regulations

• Extensive documentation approval, preparation/review experience (validation packages, monograph preparation, technical reports, technology transfer, change control, Risk, and Design Control etc.)

• Prepare Design Dossier, Common Technical Documents for EU and FDA drug, device biological and animal health submissions and Annual Reports

PROFESSIONAL EXPERIENCE

Dendreon Corporation, Morris Plains, NJ

Promoted to Director, Regulatory Affairs -CMC 1/12 to Present

Promoted to Associate Director, Regulatory Affairs-CMC 6/10 to 12/11

Senior Manager Regulatory Affairs -CMC 1/10 to 6/10

• Member of Site Leadership Team supporting various issues in running the daily business unit and stragitic planning dealing with long term issues

• Site Corporate Compliance Officer providing guidance, policy and training on legal compliance and ethic issues

• Authored sBLA submissions in support of manufacturing at the NJ Immunotherapy manufacturing site. All supplements submitted to the FDA were approved during first round reviews prior to the PDUFA dates, expediting scale up manufacturing 6 weeks earlier than projected for Provenge

• Dendreon Regulatory representative at the Centers for Medicare and Medicaid Services (CMS) defending the Medicare coverage of Provenge and the correcting the descriptor for reimbursement of payment

• Responsible for Regulatory Intelligence providing information and monitoring current regulatory climate using this information to generate creative and innovative regulatory strategies

• Responsible for responses to FDA requests, supplements, and amendments. Support site inspections

• Assess all manufacturing changes for reporting requirements

• Resolve regulatory issue. Recommend appropriate course of action to site management.

• Provide regulatory expertise to other departments as part of cross functional ream

• Perform Biological Product Deviation Report assessments and reporting, review product complaints for reporting requirements. 100% on time reporting to CBER of product deviations.

• Author SOP’s for CMC, develop and implement training programs for direct reports and all site groups to assure compliance with relevant regulatory issues

• Prepared and manage department budget and assure department operates within those expenses

PROFESSIONAL EXPERIENCE (CONTINUED)

• Develop, train and maintain highly capable and dedicated regulatory staff. Guide staff in carrying out responsibilities

• Lead regulatory project planning and conduct company review and approvals of validation packages, technical reports, technology transfers, and Risk management

GENZYME CORPORATION, Ridgefield, NJ

Promoted to Principal Regulatory Associate-CMC Supervisor 1/04 to 1/10

Senior Regulatory Associate-CMC 1/03 to 1/04

• Responsible for regulatory CMC management of marketed products Synvisc, Synvisc ONE, Seprafilm and Captique (PMA Class III devices), Captique with Liodocaine (device/drug combination) Hectorol, Thyrogen, Myzobil (therapeutics), and Carticle/Epicel (active cell therapy biologic) which included product development, regulatory filing submission strategy, for domestic and international submissions, including Japan and meet all project timelines

• Responsible for the authoring of 510(k)’s PMS’s (real time review/30 day notice) NDA’s and eCTD submissions for EU

• Local liaison member, working with the Product Team Leader for development and key marketed products providing local strategic and operational support

• Responsible for timely and accurate preparation of CMC Annual Reports section

• Maintain overview of regulatory status of changes in submitted countries under local responsibility

• Provide experienced assessments for compliance of CMC documents with current Guidelines and Standards, capable of recommending strategies to achieve such compliance

• Working knowledge of chemistry/biotechnology, analytics and pharmaceutical technology and of the drug/device development process

• Review drafts, and approve SOPs, specifications, validation reports, and labeling

• Sound approach to risk assessment and provide regulatory risks associated with product development define strategies to mitigate risks

• Responsible for coordinating subordinate activities, and career development

• Developed Risk Management tools for Regulatory Assessments

ALPHARMA INC. Fort Lee, NJ

Senior Regulatory Associate CMC 5/00 to 1/03

• Responsible for transfer of acquired Roche product to Alpharam. All supplements for the transfer of manufacturing API’s, finished products and QC product testing were submitted and approved by CVM in 3 months assuring business continuity with no back order as a result of the acquisition.

• Responsible for performing compliance verification of key CMC information from existing NADA’s and ANADA’s to comply with the 1999 “ Guidance for Industry Chemistry, Manufacturing and Controls Change to an approved NADA or ANADA” and prepared submissions to the agency.

• Prepared response to audits to manufacturing site representatives, and corporate Quality Assurance.

• Responsible for monitoring Regulatory issues for 7 domestic sites and 3 international sites and coordinate comments and responses on Regulatory issues

• Developed a NADA database to reduce the time for information searches.

• Prepared and distribution of 50 Minor Changes and Stability Reports (MCSR) and 7 Drug Master Files (DMF’s) with 100 % on time submission record

ROCHE VITAMINS INC. PARSIPPANY, NJ

Drug Regulatory Affairs – Technical Coordinator-CMC 11/98 to 05/00

• Prepared technical, scientific and regulatory information for projects assigned for drug applications.

• Prepared annual DER’s and Drug Listing

• Trained and educated personnel in manufacturing validation, SOP’s, cGMP, and cGLP

• PROFESSIONAL EXPERIENCE (CONTINUED)

• Coordinated the collection and preparation of data for drug application/product registration regarding drug components, composition, manufacturing facility, control and analytical methods

• Coordinated adverse drug reaction reporting system

• Performed site audits to assure manufacturing sites are operating in accordance with Drug Master Files

• Reviewed Phase III and Phase IV Clinical studies

• Regulatory project team leader for the launch of new products

HOFFMANN-LA ROCHE, NUTLEY, NJ

Quality Management Compliance Associate 6/95 to 11/98

• Performed audits per company policy

• Coordinated the writing, implementation, and periodic review of SOP’s for chemical, pharmaceutical, and clinical departments

• Conducted and coordinated assigned programs of quality standards for existing products, processes, and procedures in conformance with drug regulatory compliance requirements

• Performed internal cGMP inspections

• Performed computer validation studies for QMAS, RAPID and SAP Reviewed batch records for production and clinical studies

• Recipient of the 1994 Roche Service Award for excellence in manufacturing documentation improvement

ROCHE DIAGNOSTIC SYSTEMS, BELLEVILLE, NJ

Promoted Associate Scientist 01/92 to 6/95

Assistant Scientist 11/89 to 1/92

• Supervised lab staff and independently trained the department on clinical instrumentation.

• Developed and launched successful drug abuse reagent product line and developed a software program for several different instruments for the product

• Provided routine support in stability testing, identification testing, drug substances, and excipient testing for new and existing products using various analytical techniques such as GC, HPLC, UV-VIS, TLC, aqueous/non aqueous titration and laboratory instrumentation.

• Performed identification tests based upon USP to support routine testing; collection and interpretation of data in laboratory; recorded data in laboratory notebook based upon cGMP/cGLP guidelines

• Implemented phlebotomy program for Hematology product line

• Worked in manufacturing developing scale up production of Roche Drug Abuse product line

• Prepared/reviewed method Validation/Method transfer documentation

• Recipient of the 1991 Roche Women in Manufacturing Award

RIDGEWOOD VALLEY HOSPITAL, RIDGEWOOD, NJ 11/87 to 12/93

Medical Technologist Department of Clinical Chemistry

EDUCATION

Felician College, B.A.Biology 06/89

Senior Research Thesis:

Immunologic Incompatibility, Sperm Antibodies.

A.A.S Medical Laboratory Technology 06/87

Who’s Who in American Colleges 1/85 to 6/89

Vice President of Graduating Class 1989

AFFILIATIONS

Regulatory Affairs Professionals Society (RAPS) Member of Cambridge Who’s Who American Society of Clinical Pathologists, August 1987

TECHNOLOGY SUMMARY

MS Office (Word, Access, Excel, PowerPoint) AMAPS SAP LiveLink FirstDocs SmartSolve Windows (all)

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