Director of Manufacturing

We are searching for a Director of Manufacturing to lead strategy and execution for manufacturing. The Director will lead all aspects of cGMP manufacturing including manufacturing, supply chain (materials handling, purchasing, shipping, receiving, warehousing), facility design/start-up and process transfer.

The incumbent will be responsible for the quality, safety and efficacy of all finished products and will ensure compliance with all applicable specifications, standard operations procedures (SOP’s) and FDA regulations. The incumbent will ensure all budgets, schedules and performance requirements are met, will improve product quality and cost through interaction with both internal personnel and external suppliers and will contribute to improving the manufacturing process. The incumbent will lead the manufacturing for both the veterinary and human markets. The incumbent will identify suppliers and negotiate pricing, will work with Quality and Regulatory to establish agreements and contracts and will assure compliance with raw material qualification through adherence to material specifications and will be a key contributor to developing manufacturing schedule that allows for the most efficient and effective use of resources.  The Director will participate in the physical movement of materials and document as appropriate. The Director will apply LEAN principles and will document all cGMP activities in accordance with company policies and regulatory standards.

Qualifications include a Bachelor’s degree in a technical field. Master’s degree or MBA preferred. 10+ years of aseptic manufacturing experience is required along with experienced with syringe filling lines. Extensive experienced with cGMP and/or ISO13485 is required. Six Sigma certification and strong interdisciplinary managerial skills are preferred. Must be able to manage a team of engineers and technicians.   Entrepreneurial mindset preferred.