General Manager & Site Head, Alachua
The General Manager (will have single point accountability for the Alachua, Florida site and will lead a cross-functional Site Leadership Team (SLT). This position is accountable for the overall manufacturing and on-time delivery of clinical and commercial drug substance and drug product in compliance with cGMP's, global health authority standards, internal and client quality requirements. In addition to manuafacturing, the site will host significant Process and Analytical Development capabilities. The Head of Process and Analytical Development will be a member of the cross-functional site leadership team. The GM role is accountable for executing the site strategic plans, day-to -day oversight and driving overall operational, quality, compliance, staff engagement, EH&S, and financial performance at the site.
The Alachua site has an existing manufacturing building currently in operation. In addition, there is another under construction which will more than double the manufacturing capacity. A new Processes and Analytical Development Lab is also being constructed to support the operation. Hence, the GM in conjunction with the SLT will be responsible for the overall start-up and staffing of the new capabilities and integration into the existing site business processes, standard operating procedures, site policies and implementation of digital applications in collaboration with corporate Digital/IT. The position will partner closely with Global Engineering and Global Digital on the design, construction, commissioning/qualification/validation (CQV) of the plant and operationaly prepare the site to seamlessly transition from design/build/CQV/ to start-up and begin cGMP manufacturing. In addition, the position will partner closely with Global MSST and the Vaccine, Biologics and other Franchises on technology transfer, process development and business development activities leading to customer development and manufacturing projects.
|NUMBER OF OPENINGS||1|
|EOE STATEMENT||Ology Bioservices,is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, gender,sexual orientation, gender identity, age, physical or mental disability, genetic factors, or military/veteran status or any other characteristics protected by law.
|ABOUT THE ORGANIZATION||Thank you for your interest in joining the Ology Bioservices team! We believe we have the most talented and committed employees in the industry with decades of combined experience in manufacturing, developing and licensing vaccines and protein/antibody therapeutics.
Ology Bioservices is a full-service Contract Development Manufacturing Organization specializing in biologic drug substance manufacturing from early stage through commercial product. The company has 183,000 square feet of manufacturing, process development and QA/QC space in our state of the art Advanced Development and Manufacturing ADM) facility in Florida. Ology Bio has 20 years of experience developing and manufacturing drugs and biologics for the US Government, and over $500M in government contracts awarded over that time.
The company expanded to Commercial Manufacturing upon the move into the new facility in early 2017. Our infrastructure provides unique services to our clients, including full regulatory support from preclinical through licensure, clinical trial operational support and bioanalytical testing, as well as cGMP manufacturing up to Biosafety Level 3 (BSL3).
We offer outstanding career growth opportunities, excellent fringe benefits, and competitive pay.
We are an Equal opportunity Employer
|POSITION||General Manager & Site Head, Alachua|