Responsible for guiding the entire product lifecycle, from design to launch and then active sales and support. Understand customer needs, define product requirements, and drive the execution of the product roadmap in alignment with the company's strategic goals. Essential Functions -Market and User Research: Conduct thorough market research to identify customer needs, pain points, and market trends. -Product Strategy: Collaborate with engineering, production, marketing, and sales, to define and prioritize product features and enhancements. Develop and communicate a clear product roadmap that aligns with business objectives and market opportunities. -Cross-functional Collaboration: Work closely with engineering teams throughout the development process, providing guidance and clarifications as needed. Work with marketing and sales teams to develop effective go-to-market strategies, product messaging, and sales materials. -Product Launch and Adoption: Plan and execute successful product launches, including coordinating marketing campaigns, training sales teams, and monitoring product adoption. Continuously gather feedback to improve the product line based on real-world usage. -Product Performance and Analytics: Define and monitor key performance indicators (KPIs) to assess product performance and measure success. Use data to identify opportunities for product optimization, feature enhancements, and new product development.

-Launched a new sterile aqueous flush & lock solution product line. -Developed and implemented all aspects of production operation, including suite design and construction.-Hired and trained staff utilizing aseptic processing sterile fill finish steps to fill prefilled syringes and serum vials with proprietary vial access.

Collaborated with cross functional teams to integrate GTIN across three manufacturing sites located in New York, Pennsylvania and Colorado.

Oversaw startup manufacturing operations and site where biosynthesized SYNTHECEL™ Dura Repair was manufactured and packaged.Managed team of development engineers and production team spanning 1st and 2nd shift. Designed and established on-site warehouse.Resolved major disruptions to manufacturing, building power supply failures.Introduced and fostered continuous improvement concepts through Kaizen events, 5S, and lean manufacturing concepts. SYNTHECEL™ Dura Repair is composed of biosynthesized cellulose and water and has a construction of non-woven, interconnected cellulose fibers. SYNTHECEL™ Dura Repair functions as a mechanical layer which covers and repairs the dural defect while preventing further cerebrospinal fluid (CSF) leakage.

STERIS Barrier Products (formerly General Econopak, Inc.) provides solutions in the areas of aseptic technique, sterilization, cleanliness, and protection of personnel & equipment for the pharmaceutical, biotechnology, veterinary, and allied markets. Managed $3.1 territory that included west half of contiguous United States, plus Pennsylvania and New Jersey. Promoted sterile barrier products at pharmaceutical and medical device manufacturing trade shows and educational events.Manufacturing Operations Assisted:-Sterile Fill Finish-Lyophilization-Biotech (Bulk Antibody Production/Purification)-API Manufacturing-Compounding-Oral Dosage (Liquid, Gel Cap and Tablet)-Contract Manufacturing Organizations (CMOs)

Oversaw upstream and downstream manufacture of large molecule antibody biomarkers for use in cancer detection assays.-Responsible for overseeing upstream antibody production and downstream purification, concentration, and filtration processes-Revised batch records, logbooks, and SOPs-Executed non-conformance investigations utilizing TrackWise quality system-Designed and implemented CAPA plans then assessed results for effectiveness monitoring

Oversaw the cleaning out of place (COP), assembly, and autoclave sterilization of equipment in support of upstream and downstream commercial manufacturing operations for the production, antibody purification and bulk fill of Remicade® (infliximab). -Coordinated daily, weekly and monthly production and maintenance activities-Ensured daily, weekly, monthly, and semi-annual cleaning and sanitization was performed per procedures and proper documentation completed and reviewed in logbooks.-Reduced equipment breakdown frequency through the use of Operator Asset Care (OAC) program-Decreased rate of errors by implementing visual aids and SOPs to improve clarity of SOPs.

Cultured Chinese hamster ovary (CHO) cells to produce monoclonal anti-body using large scale perfusion fed bioreactors. Harvested monoclonal antibody (mAb) to be purified downstream using chromatography in support of bulk production and fill of Remicade (infliximab).-Performed clean in place (CIP) and steam in place (SIP) procedures on perfusion fed bioreactors and harvest hold vessels using human machine interface (HMI) communication system and DeltaV system to ensure cleanliness and sterility for production-Inoculated 100L and 1000L bioreactors-Monitored cell growth and adjusted media and harvest rates-Prepared samples of supernatant daily tracking of cell activity, pH and bioburden.

Prepared equipment for use commercial manufacture of bulk antibody. Daily activities include disassembling, cleaning, assembling, and steam sterilizing of process equipment used in upstream manufacturing activities. Performed room cleaning and sanitization activities ranging from daily to semi-annual. ·Authored and revised standard operating procedures (SOPs) of high detail to reduce erroneous assemblies. ·Designed shift schedule and maintained overtime for personnel to ensure overtime was allotted equally. ·Constructed scale diagrams of production parts and assemblies using Microsoft Visio Tech to serve as job aids.