Supporting start-up medical device companies with operations expertise.

Responsible for improving efficiency within operations of science-based biomedical organization specializing in developing solutions for nutrition, health, and sustainable living. To that end, I oversee operations of two manufacturing facilities with responsibility of increasing efficiency. In addition, I drive processes behind customer deliveries, supply chain, supplier management, distribution, quality control, manufacturing engineering and safety, health, and environment (SHE) efforts, while also managing operations and COGs budgets and serving as site director.

Recruited to champion the development of operations and structure for injectable drug delivery manufacturer from the organization’s headquarters in York, Pennsylvania. In this role, I was tasked to align operations and structure, overseeing functions of 165,000-square-foot good manufacturing practice (GMP) clinical trials/pharmaceutical facility. Areas of responsibility included managing $6M operating budget, quality control and continuous process improvement, supply chain, and deliveries. Spearheaded recruitment, hiring, and training of staff for shift the organization’s positioning from developer to a manufacturer. • Grew support personnel from two experienced manufacturing professionals to 25 as a result of a successful change management shift across the entire organization, taking the company from developer to manufacturer. Director Labor increased from 10 to 80 employees.• Increased capacity from 1,000 to 10,000 products delivered per week during first 18-months. • Successfully launched 10+ products variations through clinical equivalent • Conceived, developed, and implemented new sales and operations planning process to ensure current and future success for the organization

Served in multiple, progressive capacities over two decades, working domestically and internationally. Roles held included Senior Manager, Strategic Manufacturing; Senior Engineering Manager; Operation Manager; R&D Manager; Engineering Leader. Notable accomplishments and contributions throughout duration at the organization included: • Serving as trusted team member of confidential eight-person, cross-functional team tasked with identifying cost- and performance-improvement opportunities across the entire manufacturing organization worldwide, 10+ sites.• Reduction of backorders by $500,00 through a six-month plant improvement project, focusing on process improvement and human resources-related changes, including the introduction of improved work schedule for third-shift workers, cutting absenteeism by 50%. Addition of safety awareness and training contributed to reduction in safety lost-time accidents by 50%.• Implementation of lean manufacturing processes for one transfer reduced lead time from six weeks to six days, eliminating 90% of work-in-progress (WIP) goods.• Launch of three new products incubated in the company’s Pilot Manufacturing operation, transferring the products from design and development to standard manufacturing plant with an estimated annual sales potential of $3M.• Implementation of lean manufacturing concepts into Pilot Manufacturing facilities, resulting in a $1M cost savings over a two-year timeframe and making facilities 45% more efficient within three-month period.• Advocated internally for capital equipment investment of more than $2M, including design and development of two automated assembly machines, resulting in streamlined operations and overall •cost reduction. Completion of three product transfers within a two-year timeframe, resulting in addition of 180 direct operators and more than 50 pieces of equipment.