Experience / Qualifications

BS Biological Sciences-Widener University

Capabilities: Program and Project Management in R&D, Clinical Scale-up to Commercial manufacturing launch for controlled release ethical pharmaceuticals and tactical implementation manager with annual budget of 12 to 25 million n Capital Projects. Hands-on leadership with effectiveness in Pharmaceutical/Vaccine Manufacturing Engineering Design, process control technical optimization, process validation, quality systems compliance design (QbD) and remediation. Validation strategic and tactical program design and implementation accomplishments for three new GMP facilities. Responsible for directing new products PAI approvals, scale-up, drug product technical transfers and commercial launch. QC Lab Instruments qualification and test method validation, clinical product development, Design of Experiments manufacturing process pilot scale-up.

New R&D/Mfg./Pkg. Facility build, Capital Projects QA compliance Program direction, New equipment purchase, commissioning OQPQ Qualification, and Process Validation for biological (vaccine) and ethical drug manufacturing and packaging plants. Cleaning validation program development and implementation, test method validation, comprehensive computerized systems validation.

QA/QC Management; QbD, QMS, non-conformance trending, Deviation reporting, Change Control design and implementation, policy, procedure and validation program design, implementation and maintenance. CAPA and customer complaint investigation, root cause analysis, dFMEA, pFMEA expert for Biopharmaceuticals, Pharmaceuticals and Medical Device operations in the EU and USA.

Key Accomplishments: Proven problem solving skills in Manufacturing Optimization, Process Validation effectiveness, QA/QC compliance, and Regulatory remediation.

Independent initiative resolving low solid dose mfg. yields (70%) increased to 95% with recovery of 6 months of quarantined product by implementing new tablet press and 100% eliminating uncontrolled product flow root cause.

Successfully supported JNJ Project Saturn Team to conduct technical transfer and process validation for Oral Contraceptive Product line. Purchased new process equipment: I-bar heat traced blenders, tablet presses and transferred the UK mfg. process to the Swiss mfg. site Cilag AG) and successfully validated with EMA approvals for 7 products in 6 weeks. Recipient of the JNJ Product Quality Award

Supplier quality remediation for Pancrelipase biological product entailing partnering with swine Pancreas organ rendering suppliers to implement equipment (mills/grinders) qualification, change management and preventive maintenance programs to stabilize tissue properties and increase enzyme stability. Validated new API changes to reduce QC assay variances. Recipient of the JNJ Product Quality Award.

Process Optimization of the aqueous Dri-cota process by upgrading HEPA air handling system, changeover to a larger scale Accela-cota with real time process control, feedback automation to improve spray rate and cycle time. Specified variable speed pan drive control to prevent power spike losses resulting in 10 lots annual destruction. Recipient of the JNJ Product Quality Award.

Through my independent initiative, examination of CAPA root cause report for a drug manufacturing process under FDA Warning letter resulted in my disapproval of the report as the cited cause was obviously 100% incorrect. I presented to executive management a proposal to attain FDA approval to conduct a more comprehensive investigation based on the expectation that the true root cause was API supplier quality based or due to variances in sodium alginateseasonal variances. The 3 yr. old commercial drug product was implicated as poorly validated because of a massive spike in customer complaints citing product instability and prompting an FDA warning letter and full commercial product recall. In 5 months my hand-picked R&D, QA, QC, Engineering, Manufacturing and Bio-statistics team provided irrefutable statistical evidence that the root cause of failures was not process related but due to a substantial increase in API particle size preventing suitable compression. Investigations also proved that dew point controls for the coating process were not required. After submitting the technical report, the FDA rescinded the warning letter and product recall, granted removal of MBR dew point monitoring and control specifications and granted emergency approval of a new API supplier (Knoll for Verapamil). Advantages involved preventing an estimated 20-million-dollar product recall loss, new supplier API cost was 30% lower than initial supplier and MBR changes were immediate.

In less than one year I lead a team of QEs to scale-up and validate three new ethical drug product lines and the FDA was called in to conduct post-validation approval and all three products were granted commercial release increasing corporate manufacturing revenues form 87 million annually to 200 million annually.

I was sought out by a new controlled release pharmaceutical start-up company to lead their new facility build and new product commercialization program. In 6 months under my leadership a site quality plan and validation master plan was FDA approved for the first GMP facility where I designed the purchase, commissioning, qualification, and validation program. Eighteen months (18) after starting this job as QA Validation Manager, our first R&D, Mfg./Pkg. site was FDA/EPA approved and our first cardiac product line was validated and FDA approved increasing stock price form 10 / share to 115 / share resulting in a 2 for 1 stock split. In six (06) months I validated the second controlled release cardiac drug product and gained immediate FDA approval. Stock price increased from75/share to 115 per share when the second two for one stock split was announced.

Two (02) years into my QA Validation role I was awarded a promotion to Capital Projects Engineering QA Compliance director and R&D strategic advisor to manage 11 new drugs in the pipeline. I prevent an FDA PAI rejection by innovating independently a cleaning validation program despite Sr. management policy no CV was required because all products were under a single API. I knew R&D was at risk and when the FDA announced that a CV program would be needed to allow for further PAI considerations, I presented my Policy and procedure CV documents and immediately the FDA granted PAI approval for three new drug candidates and required immediate CV implementation. I worked with R&D analytical and QC lab management and we process over 1000 CV swab samples in 3 weeks for all R&D and Mfg., and Pig equipment and the FDA unconditionally approved all recovery, carryover, detergent specifications and the program was instituted for all 11 drug candidates with no failures or FDA observations. Awarded by the CEO the Andrx Quality Innovation Grant

I successfully commissioned the second (leased) facility in year 2 due to acquisition of Aspire Pharmaceuticals and managed the qualification of utilities (ultra-purified water, dehumidified HEPA HVAC systems)allowing for product development of three female hormone products derived from horse urine in a period of 3 months.

In the following 2 years my team of 38 QE consultants and 25 in-hour technical, QA staff qualified a third new facility and two additional drug products where an additional 90 manufacturing equipment purchases lead to IOPQ qualification and process, computer infrastructure, 4 ultra-pure water systems, 3 compressed air systems and 24 HEPA HVAC systems.

In 2006-2008 as Sr. Quality Engineer for a EU pharmaceutical Vaccine manufacturer, my work entailed engineering design review and Gap analysis of the EU vaccine site manufacturing validation program to justify a DHHS 300-million-dollarcontract for the design, development and construction of a US based H5N1 bird flu vaccine manufacturing and packaging plant. I successfully identified multiple conflicting QA / QC validation compliance problems in the EU corporate manufacturing site implemented corrective actions and subsequently specified the US – FFD-CBER and ISO site manufacturing requirements to leverage the existing (10 yr. old) untested H5N1 vaccine process controls including improvements to WFI – steam generator systems, upstream and downstream equipment and process automation requirements, upstream supplier quality changes to remove animal protein products and define more effective maintenance for the sterile vaccine process train. I lead the EU R&D team to improve vaccine process controls through 23 trail runs where the number of contamination issues found were successfully resolved resulting in six full scale trial lots that met with DHHS acceptance. I also lead the validation of US based CRM system design, build and go-live validation where my team was the recipient of the corporate Quality Effectiveness Award and also the industry top ten deployments award by Infoworld.

Work History

April 2017 – present: Zimmer Biomet: Sr. Quality Engineer to address process and compliance gaps for the aseptic monomer and antibiotic powder manufacturing and packaging operations. Managing NCR, Deviations and proposing validation remediation project and enhancing current procedural controls

July 2016-March 2017 Ethicon

Research Scientist providing QC Test Method analysis, and re-validation assessments to support a comprehensive 175 test method re-validation program. Responsible for Qc instrument purchase, installation, IOPQ testing, computerized system testing, technical reporting and Qc lab analyst new instrument implementation training. New computerized systems (21 CFR p.11) installation operation and performance qualification team lead for Metrohm KF Oven and Perkin Elmer Frontier MIR FT-IR UATR analytical systems

2015 – 2016 United Medical Enterprises

QA /QC/RA Manager addressing daily manufacturing release, internal and external audit management and follow-up change implementation and reporting, manufacturing expansion qualification and process validation projects, NCR daily disposition reporting, new product R&D stability testing support, Health Safety and Environmental controls management, Operations, QA, QC procedure training, and supplier quality audits and problem resolution.

2014-2015 HeartWare Medical Device Implants,

QA Compliance SME CAPA Lead- performing quality systems assessments and investigations for quality systems, computerized systems and product management and control systems.

2013 Janssen Pharmaceuticals

Project Manager for the Janssen Doribax Global Product Recall, Market Authorization Transfer of the Doripenem antibiotic. The Marketing divestiture of the Shionogi product to Takeda Pharmaceuticals determined the Scope of work that covered strategic planning of Health authority recall requirements, regulatory submittal requirements and the product distribution activities of ~40 countries (EU, Latin America, South America, Africa, Southeast Asia and Russia. Completed the global plan and defined the submittal requirements and the roles and responsibilities of Janssen and Takeda staff worldwide.

2013 – 2014 AstraZeneca

North American Quality, Compliance and Security Manager for IS/IT Project

Manage offshore test teams and domestic project managers (6) for QA Validation testing, protocol development and execution review and approval of FDA, Sox and non-regulated data systems under the new integration of services and decommissioning of obsolete hardware internationally.

Successfully eliminated testing errors and completed migration on time.

2012- 2013 McNeil Consumer Pharmaceuticals

QA Validation remediation lead performing Gap analysis and developing a Packaging Risk Management Program and Validation Remediation plan for two North American Manufacturing/ packaging sites under FDA Consent Decree. Supported two JNJ R&D/Qc labs in developing new lab instrument IOPQ protocols and CSV protocols.

2011 Client-Novartis Pharmaceuticals

QA Validation Lead- Comprehensive Product and Process gap assessments of HVAC, Utility Maintenance programs, contract product Scale-up through commercial validation, packaging and manufacturing process failures, and customer complaints for Prescription, OTC & DEA products.

2010 Client Valeant Pharmaceuticals:

QA Manufacturing Compliance Lead

Conduct review of CMO validation, change control and QC OOS/OOt reports and write annual Product Review for all products form three different CMOs

2010 Day and Zimmerman

Business Development Manager

Responsible for building new 2nd and 3rd Tier FDA Clinical Development and Manufacturing clients for staff support relationships focused on qualification and validation of GMP and GLP operations.

Developed a new client services contract and teaming agreement with a 3rd tier Biopharmaceutical company in Florida for a multi-million dollar BARDA DHHS advanced manufacturing flu vaccine high volume output facility build.

2009 LifeTek Solutions-

Engineering Systems Commissioning / Qualification SME

Responsible for completing the commissioning package binders for the New GMP manufacturing facilities, HVAC- HEPA, Compressed Air, Purified Water, BMS, systems.

2009 Guidewire Medical Technologies

QA CAPA, Process Operations

Advised the Vice President of QA on process control regulatory standards. Responsible for analysis and development of a remediation strategy to define response details to an FDA Warning Letter citing process validation deficiencies.

2009 Nugen Technologies Inc.

QA Mfg. Ops ISO 13485 Compliance SME Scope of work covered R&D and Mfg. Operations, QS GAP analysis and QA validation testing, emergency preparedness planning, SOP, protocol upgrades and revisions.ProvideValidation services for R&D and Manufacturing operations to convert the Quality system from ISO 13485 to an upgraded quality system to meet FDA cGMP regulations.

2008 Novartis - QA Manufacturing Process Control SME

FDA Warning Letter remediation strategy implemented on QMS discrepancies for six banned products, process validation discrepancies and unresolved CAPA Investigation Reports. Provided root cause analysis of 10 QA CAPA projects and cited poor change management, procedural control and weak Performance qualification studies for drug product manufacturing scale-up.

2006-2007 NNE Biologics:

QA Project Manager and QE Validation Lead for several manufacturing development and computerized system projects:

DHHS Pandemic Flu Vaccine Development and Advanced Mfg. Contract. Extensive Internal R&D, Validation and vaccine manufacturing operations audits to verify CBER US compliance. Identified numerous supplier quality issues for biological contamination risks.

Netherlands QA Engineering Gap analysis for Mfg. of MDCK cell propagation and contamination controls, packaging line syringe packaging containment and validation program risk assessment and gap analysis.

QA reviewer, process optimization adviser of 23 trial runs and technical reporting to DHHS.

QA Project leader and approver for CRM virtual sales and marketing customer management system under 21 CFR part 11 requirements. The Cedigem-dendrite Fusion CRM project was cited by INFOWORLD e-magazine as a Top Ten Best Deployment of 2007.

QA Project leader for the Medicare, Medicaid, Federal Supply Services drug pricing software program Model-N design, build, validation training, system validation accomplishments.

Periodic review of site QC lab operations and QC operations auditing

2001-2006 AlanAssociates Engineering Consultants

Validation Projects Manager supporting biological, pharmaceutical and healthcare company quality compliance and validation support including biological manufacturing start up master plan, equipment qualification, SOP development, process validation as well as computerized system validation and staff user acceptance training and other technical development temperature mapping and process control validation effectiveness Gap analysis and Risk Management program development.

Client- Roswell Cancer Institute: System Implementation SME

Eclypsis Operating System Software Go-live deployment and nursing staff training manager and problem resolution field agent.

Client- GE Healthcare (07-2005 to 04/2006)

Validation Manager, Manufacturing Computer Automation projects at three sites US/Mexico

Mercury Suite upgrade to meet FDA 21 CFR part 11 regulations. Selected for additional project work to support Manufacturing sites in WI and Utah as validation process management remediation advisor.

Client- Forrest Labs: Test Engineer (05 to 06/2005)

CSV Testing SME

SAP-R3, CRM Integration Testing design and development.

Client- Schering Plough: QA Consent Decree Mgr. International Remediation

Program Execution Office QA Manager and QA Team Lead-Consent Decree and CFR part 11

International Training Instructor (US, Canada, Puerto Rico, Ireland, Germany, Belgium)

Director for Validation SDLC CSV remediation activities at 11 sites globally. Conduct external Quality audits for Compliance to PMO specifications, standards and regulatory compliance.

Responsible for technical and regulatory content of SDLC deliverables, SOPs and Packaged IT Solution Kits per 21 CFR part 11 FDA cGMP requirements. Project Database System Administrator for over 3,000 cGMP documents and 400 global users.

Client- TE Diagnostics Phoenix Az.

Equipment qualifications, biologics and API Lyophilizing process computerized controls upgrade, temperature mapping, and LIMs re-validation manager.WFI water systems design, installation and validation.

Client- Regeneration Technologies – Biological Medical Devices, Gainesville FL

Prepare the New Facility Validation Master Plan,SOP development and approval, Critical Utility IOQ protocols, sterile systems process control specifications and Developmentof WFI system specifications.

Client- Watson Pharmaceuticals Miami FL

Technical transfer document preparation, gap analysis and Annual Product Review report creation, technical analysis and reporting for all products and processes prior to Technical transfer.

ANDRX Pharmaceuticals(Start-up Company- ADRX {NASDAQ}) 1996 to 2001 Ft. Lauderdale FL

Capital Process Engineering QA Validation Program Dir.: Responsible for the purchase of manufacturing and packaging equipment to support new facility builds for a publically traded start-up pharmaceutical company. Gained a wealth of knowledge concerning the implementation and coordination of site construction of three (3) new GMP facilities. Managed all facility commissioning test teams for QC labs, Critical utilities, manufacturing and packaging equipment for four (4) solvent based polymer formulations used in fluid bed coating to create oral controlled release prescription drug products.

1.Under the direction of Sr. executives, Steve designed and implemented multiple quality, technical programs to successfully scale-up, validate and launch 4 new drug product lines covering three (3) new GMP construction, manufacturing facilities

a.Equipment Design specifications, equipment purchasing, equipment installation, qualification and validation of numerous finished package configurations for commercial distribution.

b.Responsible manager for critical utilities design specification compliance, via IOQ testing of 25 HVAC-HEPA systems, three ISO-13485plant Process air systems and the design, installation and qualification testing of five (5) USP –Purified water Turnkey systems.

c.Creator of the Corporate Safety, Change Control, process, computerized systems Validation and cleaning validation programs. Managed all qualification and validation projects over 3.5 years.

2.Created the GMP QA operational SOPs and subsequently trained QA, QC, Mfg., Pkg., Maintenance, Engineering and R&D staff in the use of pilot scale, manufacturing, packaging equipment.

3.Most responsible site person for FDA audits, Pre-approval Inspections, and Post Validation Inspections.

IVAX Pharmaceuticals: 1994 - 1996 Miami FL

QA Manager: Mfg./Pkg. Operations, Document Control, New Product Launch

1.Managed the customer complaints investigation response to an FDA Warning Letter providing statistical proof in 5 months, resulting in the FDA immediately rescinded the Warning letter that saved the corporation ~20 million dollars.

2.QA site FDA representative for all QA GCP, GLP and GMP operations, managing approved drug product technical transfers (US to Ireland), domestic and Canadian product release and Packaging operations insert / outsert, labeling approvals. In 12 months Steve Lead the quality engineering team to validate and gain FDA approval of three NDA/ANDA drug products.

3.Supported medical services in the development of the corporations first NDA drug product (proglycem) to ensure preparation of the investigational products were manufactured packaged and labeled in compliance with GCPs and the Corporate Trial program..

4.Audited Clinical sites to ensure compliance to QA CGP protocol requirements and Qc technical analytical reports were saved electronically under a validated hardware/software database to meet proposed 21 CFR part 11 guidelines.

5.Responsible for CAPA implementations, APR development and Customer Complaints Investigations, one which lead to an API supplier problem discovery.

6.QA Compliance Leader and team director for Product Customer Complaints (CAPA Development), Process/Lab Failure analysis and technical/deviations, and QC-OOS Investigation reporting, Annual Product Reviews, supplier quality investigations. Steve directed the operations for the R&D scale-up validation team activities to receive FDA approval of three (3) ANDA and one NDA commercial drug product approvals in 12 months.

7.Project Manager for Facility renovation and expansion entailing Commissioning, qualification, validation of HVAC, ISO-Process air, purified water systems, and packaging line process capability expansion.

R.W. Johnson Pharmaceutical Research Institute 1991- 1994 Raritan NJ Research Associate

Responsible for the scale-up of powder formulations using Design of Experiments and six sigma methods.

Duties included process control data generation and statistical analysis, correlation and report writing to provide smooth transition to full-scale production.

Global site Best Practices review QE

oOrtho Diagnostics WFI systems design review

oOrtho Pharmaceuticals – high sheer Mixing torque automation analysis, development and validation

oMcNeil consumer Blend validation benchmarking

oMcNeil Pharma dorado site Packaging optimization and best practices analysis

Responsible for troubleshooting process control problems, recommending changes to processing and formulations and providing documentation to support changes to equipment, process controls and raw material grade or supply source.

Provided Quality Engineering validation support to the UK to Switzerland Technical Transfer and Validation project for seven (7) oral contraceptive drugs.

Process train Qualification / Validation list:

Blenders (V, I-bar, Slant cone, Horizontal); High Shear Mixers: (TK Fielder); Mills (P-K, Comil), Tableting (Fette, Manesty, Stokes, Korsch, Killian, Kikusui); Encapsulators: (Capsugel, APT, Index, H&K, Bosch), Fluid Bed Granulator/dryers (Glatt, Aeromantic), Coating Pans (Accela-cota, Dria-cota, O’Hara); Packaging (VanRX, Klockner)

Training

Green Belt Training Certification: Dupont- Johnson & Johnson

Risk Management Training – Andrx Group

SPC Training: W. Edwards Deming Manufacturing and Packaging Validation

Project Management Certification – Andrx Group

Computer Systems GAMP 21 CFR part 11 Validation Training – Alann Associates

Advanced Manufacturing Concepts Bird Flu Vaccine Mfg. Seminar – DHHS

GLP training for analytical testing / instrument analysis

2 yr. comprehensive STEP Training Dominion Resources Nuclear Power Chemical Certification

Fire Safety Training: VEPCO

Good Documentation Practices Training _Multiple corporate programs

Root Cause Analysis Training: IVAX Corp.

CAPA training: IVAX Corp.

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