Medical Device Quality

Operational Excellence and Quality Leader

Operational Excellence and Quality Leader with 25 years proven history of directing and managing world class Medical Product Operational and Quality organizations. Including founding of TNTC Inc., serving as Managing Director; whose objective is to implement operational excellence and quality solutions for fast-track biopharmaceutical, pharmaceutical, medical device and combinations product companies.

Additional capabilities:

• Executive Communication Recruitment & Retention • Alliance Negotiation

• Leadership & Motivation • Risk/Change Management • Cross Functional Management

• Corporate Development • Strategic Implementation • Business Acumen

Accomplishments

Leadership of functional groups that consistently provided a unique combination of abilities which translated challenging strategies into actionable objectives. These objectives delivered high quality and timely outputs, which resulted in accelerated operational excellence and quality; as listed below:

• Designed, built and managed operational excellence and quality groups up to 75 FTEs at multiple strategic operating areas for biopharmaceutical and medical device corporations.

• Successful representation for licensure of FDA/EMEA/MHRA novel pharmaceutical and medical device products.

• Successful development and implementation of platform Quality Systems for three large multi-national and ten (10) early development companies that included CFR and ISO regulations.

• Successful experience in control, management and operational improvement of multi-million dollar CRO/CMOs projects and products through metric-based quality indicators integrated within Supply Agreements.

• Successful out-sourcing/in-sourcing experience for large capital (>$1MM) technical services such as: Auditing, Clinical Monitoring, Biostatistics, Engineering, Manufacturing, In-process Control, Technology Transfer, Qualification, Validation, Calibration, Maintenance, Materials Management, and Analytical Methods.

• Development of successful CMC section applications/correspondence such as: 510K, 505b, NDA, ELA, PLA, and response letters to regulatory agencies.

• Built, implemented and managed efficient integrated project management strategies for new capital (>$750MM) and new product(s) (>10) at five (5) separate companies.

• Successfully direction/implementation of data integrity systems including multiple automated enterprise and clinical data management systems with total commissioning cost of >$15MM.

• Operational excellence and quality lead on 15 successful new drug substance and drug product facility start ups, including 7 licensed facilities with aseptic and multi-product capabilities.

• Successful process optimization, qualification and registration lot release for four novel drug products, five drug substances, two diagnostic antigens, and two diagnostic products including comparability assessments supporting bio-similarity of drug substance and drug product(s).

• Developed and implemented streamlined GAMP life-cycle programs that incorporated risk methodologies/decision making for: systems, processes, analytical methods, materials, and training that resulted in ~40% cost reductions of bench-mark costs while providing increased operational excellence.

• Business executive with 6-plus years of experience managing strategic, technical, logistical, operational and quality improvement project teams, as a consulting corporation.

Professional Experience and Responsibilities

TNTC Inc. 2005 – Present

Managing Director –Pleasant Hill, CA

Provider of operational excellence and quality engineering solutions at the following corporations while reporting to executive, senior and operation level management at: Acologix, Allergan, Alza, Amgen, Amylin, Avecia, BioMarin, Cell Genesys, Chiron, Genentech, Genitope, Impax Laboratories, Jennerex, MQA, MedImmune, Novartis, Nuvelo, Pathwork Diagnostics, Planet Bio, RSCSI, Solstice NeuroSciences, TM Inc. and Zosano Pharma.

Professional operational excellence and quality engineering solutions included: Warning Letter Remediation, Mitigation of Process Deficiencies for Generic Manufacturer Portfolio, Facility Licensure, Clinical Data Management Development, Cleaning Validation, Automated System Qualification, Risk Assessment/Mitigation, PLI Readiness, Change Management, QbD, Basis of Design, Process Validation, Drug Substance Comparability Assessment, Gap Analysis, Project Management, Corporate Master Planning, Corporate Policy Development, Part 11ER/ES Implementation, Quality System Development, Technology Transfer, Analytical Methods Validation, Viral Clearance, Warning Letter Remediation, Quality Agreements, Project Management, Laboratory Design, ISO Compliance and Acting Director Quality Engineering.

Abgenix Inc. (Acquired by Amgen) 2001 – 2005

Quality Engineering, Director – Fremont, CA (Promoted from Assoc. Dir., QA-Validation)

Reporting to Executive Vice-President Operations: responsible for area release, quality audits, qualification, change management and centralized training activities. Additional responsibilities included: system and process specifications, system and process qualification, change control, training, CMC team lead, quality area release/new product introduction, analytical methods qualification and validation, automated systems validation; including project budgets, cost center and administration responsibilities.

Aviron (Acquired by MedImmune Vaccines) 1998 – 2001

Associate Director Quality– CA, PA, and UK (Promoted from Mgr. QA and Sr. Mgr. QA)

Reporting to Sr. Director of Quality: responsible for release, validation and change control activities at 2 California locations, CMO in UK and Aseptic Product Fill-Finish in PA. Additional responsibilities included: system and process qualification, change control, calibration, preventive maintenance, CMC team lead, area release, and automated systems validation; including project budgets, cost center and administration responsibilities.

Insite Vision 1997 – 1998

Manager Engineering – Alameda CA. (Promoted from Senior Engineer)

Reporting to Director of Manufacturing: responsible for technology transfer, validation, change control, preventive maintenance, and calibration for diagnostic kit manufacture, bulk drug substance and drug product pilot plant; CMO operations and budget responsibilities.

Chiron Corporation (Acquired by Novartis) 1991 – 1997

Validation Engineer – Emeryville CA (Promoted from Validation Specialist, Sr Validation Specialist)

Reporting to Director of Validation: responsible for diagnostic, antigen, and sub-unit vaccines, qualification/ validation and change control for system validation for facilities, utilities, equipment, process, and cleaning .

Pfizer Hospital Product Group 1989 – 1991

Medical Device Laboratory Supervisor, Irvine CA (Promoted from Quality Control Specialist)

Reporting to the Director Quality: responsible for testing lab management and quality release of 4 different franchise groups of medical devices.

Allergan Inc. 1987 – 1989

Quality Laboratory Specialist, Irvine CA

Reporting to the Manager of QC Microbiology: responsible for sterilization and aseptic processing validation. Validation of microbiological methods for product specific analytical methods.

Expert Knowledge

• Master Planning • Contracts and Quality Agreements

• Change and Risk Management • Commissioning and Qualification

• Product/Process Validation • Cleaning Validation

• Aseptic Processing

• Contamination Control • GAMP 5 Lifecycles

• Sterilization

• Release: Equipment, Facilities and Product • Statistical Process Control and DOE

• Technical Writing • Sigma Six, QIP and QbD

• Project Management • Multi-Product Processing

• Clinical Data Integrity

• CFR and ISO regulations

• ISPE Guides to Industry • Documentation

• Automated Processing

• Auditing

Industry Product Knowledge

• LVP and SVP --Sterile • Combination Products

• Solid Dosage--Tablet, Capsule, QDT

• Biopharmaceuticals • Synthetic Bulk Drug Substance (API)

• Medical Device -- Class I-VI Categories

• Diagnostic Antigen and Kits • Biologically Derived Drug Substance (API)-Microbial and Cell Culture.

• Live Attenuate & Sub-unit Vaccine • Storage and Distribution

• Data Services • Automated Instrumentation

Education

• BSc. Biological Chemical Engineering, Microbiology, The Ohio State University, Columbus Ohio

Professional Associations

• Parenteral Drug Association

• International Society for Pharmaceutical Engineering

• Good Automation Manufacturing Practices Forum Member

• Project Management Institute

• American Society of Quality

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