Pharma Operations, Manufacturing, Engineering, OpEx Lean Six Sigma Black Belt and Process Validation Consultant

Expertise

• Life sciences manufacturing with specific focus to technology services, quality systems, engineering oversite, strategic and tactical planning strategies.
• Providing supply chain consulting and compliance achieving profitability goals, utilizing Lean Six Sigma.

Services

• Lean Six Sigma Black Belt.
• Pharmaceutical manufacturing.
• Pharmaceutical process engineering.
• Pharmaceutical continuous improvement.
• Quality engineering and quality systems.
• Quality Systems Implementation.
• Continuous Improvement.
• Continuous product and process validation.
• Technology transfer.
• DMAIC- Define, Measure, Analyze, Improve and Control.
• Operational excellence.
• Supply chain robustness.
• Root cause analysis.
• Project management.
• Financial, budget, cost accounting for pharmaceutical operations.
• Operations regulatory compliance.

Experience

Undisclosed Company, President - Senior Consultant, 2015 - Present

• Provide consulting services to pharmaceutical and manufacturing companies for their operational components focusing on operational excellence, manufacturing, quality engineering, technology transfer, engineering, and product serialization.
• Specific attention to: CAPA resolution, regulatory compliance, materials management, and supply chain robustness.

Ohm Laboratories, New Brunswick, NJ, Director of Engineering, 2014 - 2015

• Led a department of 26 encompassing facilities and projects with an operating budget of $2.9 million and a capital budget of $3.5 million. Brought systems, inventories, and accountabilities up to date.
• Applied Six Sigma and continuous improvement techniques for optimization of equipment uptime through maintenance activities and procedures.
• The company is under consent decree and under severe financial duress.
• Reduced engineering-related expenses by $2 million by optimizing maintenance systems and programs.
• Optimized supply chain robustness by maximizing equipment and facilities uptime in excess of 95%.
• Enhanced documentation compliance by leading extensive overhauls of maintenance programs, procedures, drawings, and facilities documentation to address issues impacting supply chain and product quality.
• Led the continuous improvement of maintenance activities by trending corrective and unscheduled activities achieving closure of over 700 past due work tickets in 2 months.
• Negotiated 20 contracts for plant services and supplies. Gained legal approval and executed contracts.
• Created Bills of Materials for preventive maintenance tasks.
• Optimized spare parts inventory and removed unnecessary purchases resulting in a reduction of spare parts spending from $60K/month to $7K/month. All work performed in SAP.
• Met regulatory requirements in equipment status reporting, maintenance, installation, and performance verifications.
• Improved compliance by tracking and trending maintenance nonconformances and re-structuring SOPs to better accommodate facilities and equipment. Approximately 40 SOPs in process of being updated.
• Aided Product Development by providing budgeting, projects, and specialized environments to optimize investigative and manufacturing conditions.
• Addressed multiple electronics and process control issues by focusing on key issues revealed in a comprehensive electrical distribution analyses and annual electrical system thermographic analyses.

URL Pharma, Philadelphia, PA, 1994 - 2013

Senior Director, Chemistry and Manufacturing Services, Manufacturing Section

• Created, staffed, developed, and led a team of 3 directors and manager, 14 professional and line staff, and managed a $7 million annual operating budget and a $9 million capital budget.
• Provided manufacturing technology transfer, process excellence, process engineering, continuous improvement, process validation, scale up, product commercialization, Lean Six Sigma (DMAIC), QbD, root cause analysis, and ongoing commercial verification expertise to this specialty pharmaceutical company.
• Championed the training, mentorship, and projects for the successful deployment of a Lean Six Sigma rollout yielding 11 Black Belts in 4 departments.
• Reduced expenses, increased margins, and enhanced profitability by leading a team of Six Sigma professionals and on track to save $4.4 million annually.
• Established an ongoing program of continued process verifications for commercial products to meet the FDA Process Validation Guidance, Stage 3 (2011, rev 1).
• Managed new product launch through process scale up, optimization and validation.
• Met corporate time frame requirements by directing 31 process validations with a staff of 4 in one year
• Maintained product purity and CGMP requirements by overseeing 40 cleaning studies and 10 full cleaning validations including active ingredient and detergent residues with a staff of 2 in one year.
• Enhanced regulatory positioning by initiating implementation of ASTM E2810-11 for inferential statistical adherence to USP UDU <905> for final product release and gaining FDA agreement thus far.
• Met 21 CFR Part 11 requirements by authoring and executing a software validation of JMP® Statistical Discovery.
• Served as Licensed Designated Representative for 50 State Boards of Pharmacy including current California Certification.
• Developed Metrics program to measure baseline of utilization of departments and personnel.

Senior Director of Engineering, 1994 - 2008

• Built and managed teams in Project Engineering, Facilities, Operations Metrology, Safety Compliance, Environmental Compliance, and Security with a staff of 60. Managed an annual operating budget of $13 million and a capital budget of $13.5 million. Maintained facilities, systems, and equipment in a continuous state of GMP, quality, and inspection readiness. Played a role in remediation of the company's consent decree within 9 months of its issuance prior to my employment.
• Managed capital projects ranging from $2 thousand through $4 million.
• Met regulatory and throughput needs by authoring or leading validation and commissioning of 260 processes spanning oral solid dose unit operations, facilities, systems, manufacturing and packaging equipment, selected laboratory equipment, and software.
• Relieved company of environmental liabilities by completing a major Brownsfield remediation, removing multiple underground storage tanks, performing Phase 1 & 2 studies on four sites, designing and installing a major wastewater remediation ($1.1 million in capital renovations and installation), upgrading effluent pH system, and obtaining SynMin permit. Gained PADEP approval.
• Successfully maintained a favorable cumulative safety record by staffing an EHS group and raising safety awareness. Sustained a record of less than 50% of the Bureau of Labor Statistics Total Recordable Cases for Pharmaceuticals for 5 years.
• Reduced utilities sales tax by justifying 88% removal thereby saving $775K over 10 years.
• Represented corporation to EPA, OSHA, Air Management Services, Industrial Waste Unit, Zoning Board of Appeals, and the local civic association.

Military

United States Public Health Service, Indian Health Services Branch Barrow, Alaska, 1979 - 1981

• Chief, Pharmacy Service, First Lieutenant, Commissioned Corps
• Solely responsible for all Pharmacy functions including inpatient, outpatient, and field health services for the North Slope of Alaska.

Honors & Publications

Credentials

• Software: JMP Statistical Discovery (Release 11), Microsoft Office, Microsoft Project, AutoCAD LT, SAP

License

• Current Maryland State Board of Pharmacy, License
• Current California State Board of Pharmacy Designated Representative, License

Academic and Professional Affiliations

• Computer Validation committee.
• Voting member, Retirement Committee (Stewardship of our 401K program, URL Pharma)
• International Society of Pharmaceutical Engineers (ISPE)
• Pharmaceutical Consultants Consortium International
• Philadelphia Business Journal
• Greater Philadelphia Senior Executive Group

Publications

• Author of numerous publications with topics in Six Sigma and Commercial Manufacturing

Education

• B.S., Chemical Engineering, University of Maryland, College Park, MD
• B.S., Pharmacy, University of Houston, Houston TX