Manufacturing SME with over 20 years of industry experience in GMP environments including hands-on technical operations, biologics production management, technical services management and inventory management. Direct involvement in successful European and US FDA inspections for multiple products.  A team-oriented leader with an optimistic perspective and out-going personality, creating the ability to motivate and align teams toward common, communicated and understood goals and objectives, while enhancing overall morale and individual satisfaction in and with our work environment. Served as team leader through rigorous campaigns to meet and exceed demanding expectations, with teams receiving zero inspection observations and successfully completing >98% of attempted manufacturing runs.  Utilizing a positive approach to promote team-oriented realization of goals, examples of team accomplishments are:

​

• Successfully executed, without failure, the registration lots for initial product.

​

• Received zero observations in shipping/ receiving and warehousing at a fill-finish facility.

​

• Achieved unprecedented success rates in demanding manufacturing environments, including 226 fermentations successful in 229 attempts in one manufacturing campaign (product Rituxan, company Idec), and 26 consecutive successful fermentations to start a new facility (company AME/Lilly).

​

• Received FDA approval for 8 recombinant products.​

​

Specializing in:

​

• Biopharmaceutical manufacturing and quality systems and operations

• Project management, facility start-up, strategy implementation

• Budget preparation/management, production/inventory planning, capacity planning 

• Personnel management/development, team building/orientation, schedule generation/coordination, training development/ implementation, goal orientation, customer orientation

• Knowledgeable of Federal and other regulations