Leading Supply Chain, Production, and Engineering for a dynamic nutritional company concentrating in complex solid oral dosage forms

• Led daily activities at contract development and manufacturing site, reporting in to president.• Managed site P&L and direct oversite of production, quality, engineering, human resources, supply chain,and development activities.• Directed initiatives to improve site performance in year-over-year revenue and EBITDA growth, improvedcustomer service, reduced cycle time, and maintained high level of regulatory compliance.• Supervised site with growing business comprised of solid oral dose, liquid dose, and topical sterileproducts.• Worked with leadership team to upgrade talent level at site, drive employee engagement, and improveoverall morale.• Collaborated with key clients and supported business development process.• Assisted in sale of Halo Pharmaceuticals to Cambrex Corporation. Aided with development of CIP andbusiness review presentations, provided confidential site tours, and fielded due diligence questions.

Supervised production and support activities at two U.S. sites producing 35,000,000 units of semisolid and liquid products.• Directed daily management of staff and budget for 200 employees operating on 24/5 schedule producing 170 SKUs.• Managed manufacturing, packaging, validation, training, warehousing, and dispensing with following short-term team accomplishments:- Reduced backorder decreased scrap rate significantly.- Developed and implemented FDA remediation plan to address equipment and process deficiencies,resulting in compliance rating change from OAI to VAl.- Expanded use of Lean-Sigma concepts on shop floor such as visual management tools and dataanalysis to drive continuous improvement.- Led drive strategic projects such as Behavior Based Safety Teams, Quality Behavior Initiative, and IQP (Lean-Sigma) certification sponsorship.

Responsible for leading validation, process improvement, and post approval changes at two US manufacturing sites. Department responsible for all process, packaging, cleaning, and IT system validation. Group also responsible for equipment calibration and qualification.

Led commercial supply chain activities associated with procurement of 140 products for Doak, Kenwood, and Aaron’s subsidiaries. Directed development and process improvement activities of commercial products at contract manufacturing and research organizations. Worked with regulatory and quality groups to properly handle product-related investigations and regulatory filings. Launched three products and oversaw three site transfers in 15 months prior to business being acquired by Nycomed (Fougera Pharma Inc.).

Managed commercial production of ethical bulk finished products on five-day by 24-hour operation. Supervised staff consisting of four exempt and 46 non-exempt employees running at 80% of capacity. Oversaw budgetary spending. Ensured compliance to all regulatory requirements and provided technical support for new and existing production and development of staff. Achieved production, compliance and safety objectives while implementing cost savings and process improvement initiatives.

Director of Controlled Substance Compliance Associate Director of Manufacturing Technology Associate Director of ProductionProduction ManagerManufacturing SupervisorPackaging SupervisorAssistant Receiving Supervisor