Supply Chain Manufacturing

SKILLS AND CORE COMPETENCIES

Sterile Pharmaceutical API/Fill finish & packaging

OEE & KPI Development/Management

Safety, Health & Environmental

Nutritional Products Manufacturing

Monthly Financial Closing

Organizational Restructuring

Medical device Manufacturing

Training and Development

ERP Systems (SAP)

Project Management

FDA/EMA/MHRA/ANVISA/Internal Audits

Delta V

Organizational Leadership

IQ/OQ/PQ & FAT/SAT

Documentum

Quality Management Systems

Labor/Material Cost Management

Process & Cleaning Validation

Trackwise

Inventory Control & Supply Chain Management

RCA/CAPA

Aspen Process Explorer

DMAIC/Lean Manufacturing

Technology Transfer

HAZOP/PHA

PROFESSIONAL EXPERIENCE

Nitto Avecia Pharmaceutical Services, Irvine CA 11/2014 – Present

Nitto Avecia provides contract parenteral formulation development and manufacturing solutions for liquid and lyophilized products.

Manager Manufacturing & Supply Chain

Responsibilities:

●Provide leadership and directions to sterile product Manufacturing (component preparation, compounding & sterile Filling), Labeling/Packaging Operation, Supply Chain, Validation and Engineering/Maintenance staff including Safety, Quality, Delivery and Cost (SQDC).

●Manage client projects through Supply Chain & Manufacturing process. Lead optimization of processes, manage and monitor KPIs.

●Develop and execute clinical stage sterile drug product manufacturing processes from post formulation development leading cross function teams. Act as primary contact for clients’ projects in Manufacturing phase. Write, review and approve protocols, scientific reports, and other technical documents for process development and production of drug products for clinical studies.

●Functions as Safety head to drive safety performance of the site. Develop manufacturing strategies, safety programs and quality culture.

●Manufacturing and Facilities single point of contact for regulatory inspections. Interacted with regulators such as FDA to represent manufacturing and facilities.

Key Accomplishments:

●Developed risk assessment for using a single lumen needle (class II device) in a kit with sterile drug product for FDA submission.

●Developed and implemented comprehensive Client Project management process – reduced 20% execution time and 10% cost.

●Developed an inventory management system that resulted reduction in operating working capital by 17%.

●Expanded the manufacturing operation from single day shift operation to 24/7 coverage for Manufacturing and QA/QC which resulted increase in manufacturing capability by 60%.

●Developed and implemented site Training matrix to close compliance gap.

●Led facility commissioning following reconstruction and Process validation of two products for INDA in EU & US.

●Validated process equipment cleaning procedures and implemented to routine operation.

●Led OSHA safety audit with zero observations.

DSM Nutritional Products, Freeport, TX 05/2010 – 11/2014

Freeport DSM facility is the world largest β-Carotene Manufacturing site located in Free trade Zone. Capacity is > 500MT/year.

Sr. Quality and HSE Manager 04/2014 – 11/2014

Responsibilities:

●Provided leadership to QA, QC, HSE, Waste Water plant and plant security for a 24/7 shift operation.

●Headed plant QMS (Quality Management Systems) including raw material, in-process and final product testing, product release, supplier audit and qualifications, Change Control, Document Change Control, deviation, CAPAs, internal and external audit program as ASQ certified Quality Auditor.

●Released final product thru SAP system.

●Site owner of Trackwise system, Documentum & PermitCliq (Electronic Safe Work Permit System).

●Provided plant expert support for DSM regulatory department with Beta Carotene specification regulations.

●Site Lead for Hazard and Operability (HAZOP) projects to achieve zero incidents.

Key Accomplishments:

●Led DSM partnership with USP to develop a new β-Carotene monograph that was used as the standardized USP samples.

●Led DSM strategic projects to implement EDM Documentum (validated electronic controlled document management system) and PermitCliq (Electronic Work Permit System). This initiative improved compliance and reduce paper use by 90%. These two projects translated to $100K/year savings to the facility.

●Led OSHA & EPA (TCEQ) regulatory inspections with zero observations.

●Restructured HSE and Quality department with strategic roles to establish subject matter expert in each area.

Sr. Manager, Manufacturing/Assistant Plant Manager 05/2010 – 04/2014

Responsibilities

●Provided leadership to Manufacturing, Packaging, Shipping/Receiving and Warehousing for a 24/7 shift operation.

●Developed site annual manufacturing plan, Capital budget, Quality & HSE goals.

●Performed month end financial closing and reporting to division headquarters.

●Managed $7mil annual budget in 7 different cost centers including Plant Maintenance budget through SAP.

●Stepped up as the Plant Manger as well as member of local investment board approving capital projects.

●Responsible for plant Turnaround/shutdowns to ensure compliance to plan, budget and schedule.

Key Accomplishments:

●Led validation team for Process Validation Project and qualified facility as API manufacturing facility.

●Executed lean manufacturing projects using DMAIC methodology to improve process & reduce mfg. cost.

1. Led process-debottlenecking project and increased plant capacity by 25% vs target of 20% ($5.4mil/yr additional profit).

2. Reduced solvent consumption and plant Haz. Waste by 19% - savings $1.16mil/year.

●Developed and formalize OEE measuring tool for the site as DSM Global OEE implementation project team member. Improved gross OEE from 75% to 89% as the asset Utilization/OEE Champion for the site.

●Developed and implemented new HACCP plan aligning with ISO22000, received ISO22000 certified status to the site.

●Reduced batch release time from 6 weeks to 3 weeks which translated to $210k reduction of operating working capital.

●Executed Plant Improvement Projects upto $800k to install chemical storage vessels, chemical line electrical heat tracing to enable uninterrupted operation in winter.

●Implemented SafeStart program as the Project Lead, achieved 3 years without a recordable incident.

Kaneka Nutrients L.P., Pasadena, TX 01/2005 – 05/2010

Nutraceutical/API facility produced Co Enzyme Q10 (CoQ10) using Fermentation process. Plant capacity >100MT/year

Production Manager 03/2007 – 05/2010

Responsibilities

●Provided leadership to main process (fermentation & Purification), Aseptic Packaging, Supply Chain Management and Plant utilities for a 24/7 shift operation.

●Managed $16M budget in Production, Utility and Supply Chain Departments.

●Oversaw all manufacturing document (SOP/Batch Records/Other quality documents) management.

●Provided back up support for DCS system engineer – Delta V process control system.

●Developed and managed KPIs in Manufacturing and Supply Chain departments.

Key Accomplishments:

●Streamlined manufacturing process and achieved key department objectives of through-put and cost three months in advance of the goal using DMAIC lean tools.

1.Increased production output by 33% thru optimizing process cycle time.

2.Reduced Solvent cost and hazardous waste cost by 20%

●Optimized labor utilization by restructuring department. This is a $130K savings per year of labor cost.

●Reduced process deviations by 50% Implementing a RCA system.

●Successfully led a project for next generation CoQ10 (reduced molecular form) technology transfer from pilot scale (from Japan) to manufacturing scale and implementation (in US). This was a patented product which helped improve cash flow by 2 folds.

Manufacturing Superintendent 01/2005 – 03/2007

Responsibilities

●Provided leadership to main process (fermentation & Purification) operation.

●Drove to closure all Manufacturing documentations, Investigations, CAPAs.

●Hired, performance evaluated and mentored 12 manufacturing technicians.

●Reviewed customer complaints, internal/external audits, prepared responses and implemented CAPA.

●Implemented process changes, process improvements collaboration with Technical Department.

●Commissioned new manufacturing facility as Key member of Plant Commissioning Team.

Key Accomplishments:

●Wrote Operation SOPs during 4-month training assignment in Japan reducing the need of expatriates to visit Texas facility, saving of $50k.

●Factory Acceptance Test for DCS systems (Delta V and Emerson’s Manufacturing Execution System (MES)) and various new equipment in overseas facilities. Optimized equipment functions prior to ship for installation, potential saving of $650k preventing downtime.

●Led Process Hazard Analysis sessions for new facility as the subject matter expert for Fermentations and Purification processes, developed process/facility to prevent safety incident.

●Led Facility validation project for OQ, PQ and PV validations, written validation protocols and led the validation team for OQ, PQ and PV to commission the manufacturing process at this facility.

Merck & Co. Inc., Elkton, VA,

Manufacturing/Compliance Supervisor 10/2002 to 12/2004

Baxter Healthcare Corporation, Los Angeles, CA

Manufacturing Supervisor 08/ 2000 to 09/2002

Baxter Healthcare Corporation, Los Angeles, CA

Technical Service Associate 02/ 2000 to 08/2000

Medtronic PS Medical, Santa Barbara, CA

Work Center Leader – Implantable Catheters 01/ 1998 to 08/1999

EDUCATION

Master of Business Administration in Technology Management, May – 2008 - University of Phoenix

Bachelor of Science in Pharmacology, Dec. 1999 - University of California, Santa Barbara, CA

Certificate of Chemical Engineering for Non-Engineers – 2010 - ASME & AIChE

Certified Quality Auditor – American Society for Quality - 2012

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