Responsible for all aspects of manufacturing and packaging of quality engineered lubricants for distribution worldwide. Petron Corporation designs and manufactures a complete line of high performance and specialty lubricants utilized in all types of industries worldwide. In addition, Petron Corporation is a leading designer and manufacturer of OEM approved open gear lubricants.

Responsible for all aspects of manufacturing and packaging of quality engineered lubricants for distribution worldwide. Petron Corporation designs and manufactures a complete line of high performance and specialty lubricants utilized in all types of industries worldwide. In addition, Petron Corporation is a leading designer and manufacturer of OEM approved open gear lubricants.

Responsible for all aspects of manufacturing of $15 million medical device product lines using ELISA (enzyme linked immunosorbent assay), Luminex bead based assays, and fluorescence end-point based assays. Managed the operations of departments responsible for processing platelets and cell culture materials, protein purification, manufacture of product components and packaging of finished products. Coordinated the transfer of products from R&D to Operations and ensured adherence to ISO, GMP, and FDA quality system regulations.• Worked closely with efficiency consultants to identify key performance indicators (KPI) of productivity, efficiency, and utilization in order to develop quantifiable metrics. Implementation led to > 97% product availability to customer request date.• Directed multidisciplinary team to develop BOM (bill of materials) and routings for products to facilitate SAP implementation.• Developed individualized documents for saleable items in order to facilitate SAP implementation.• Identified a path forward for new raw material conversion/validation when a critical raw material was no longer available. • Researched in-line labelers and identified suitable equipment resulting in 50% decrease in manual labeling.

Responsible for manufacturing of product components for $13 million product lines using ELISA (enzyme linked immunosorbent assay), Luminex bead based assays, and fluorescence end-point based assays. Coordinated the transfer of products from R&D to Operations and ensured adherence to ISO, GMP, and FDA quality system regulations.• Successfully facilitated the transfer of 6 products from R&D to Operations which involved the creation/revision of all manufacturing documents relevant to the products.• Developed documents and validation plans to implement new equipment purchased to automate ELISA plate manufacturing thus doubling manufacturing capacity.• Implemented the addition of a cap feeder system to the automated filling machine which resulted in a decrease of 400 labor hours annually. • Purchased and implemented a steam sterilizer to eliminate outsourcing which resulted in annual cost savings of $70,000 and decreased variability.• Developed validation plans and revised documents to support the design change to use EDTA in place of sodium hydroxide (NaOH) stopping solution. This change eliminated end user and staff exposure to hazardous materials and additional shipping expenses.

Responsible for manufacturing of product components for $10 million product lines using ELISA (enzyme linked immunosorbent assay) and Luminex bead based assays. Coordinated the transfer of products from R&D to Operations and ensured adherence to ISO, GMP, and FDA quality system regulations. • Researched and purchased the Oyster Bay Pump Works (OBPW) equipment valued at $300,000 to automate ELISA plate manufacturing in order to double manufacturing capacity.• Coordinated facility move from Brookfield to Waukesha, WI requiring re-validation of all manufacturing equipment at the new location to ensure proper performance. Precise planning and execution resulted in all equipment being approved for use within 2 weeks thus minimizing downtime and eliminating backorders due to the move. • Facilitated the transfer for Luminex bead based products from R&D to Operations marking the launch of the transplant diagnostics product line.• Purchased and implemented a floor scale for large scale reagent manufacture which reduced time by 50%. • Researched the reagent grade deionized water system to ensure compliance to industry standards. Involved consulting the service provider to better understand the system and regulatory standards. Implemented additional preventative maintenance measures and in-line filters to minimize contamination.

Responsible for the proper progression and schedule attainment of the department manufacturing components for ELISA based products and packaging of components into finished products. Followed procedures to ensure adherence to quality standards and regulatory compliance.• Instrumental in acquiring ISO certification which was required for international business continuity.• Assumed responsibility for the production schedule to ensure product availability, minimize backorders, and meet agreed upon shipment dates for custom orders.• Developed a process for establishing receiving specifications for incoming raw materials.

Responsible for manufacturing various ELISA product components, and packaging components into finished product. Followed procedures to ensure adherence to quality standards and regulatory compliance.

• Performed basic blood chemistry tests (calcium, glucose, etc.) and prepared specimens for in-depth analysis by technologist.• Conducted studies for validation of procedural/instrumentation change.• Maintained and calibrated instruments and prepared specimens for transport to other laboratories.