Job Location : Gaithersburg,MD, USA
About the Company
A respected biopharmaceutical company
Industry Pharmaceuticals
Type Public Company
Founded 1999
Employees 10,001+
Categories
Specialties
Business Classifications
About the Role
We are looking for a passionate and driven Director of Process Engineering to spearhead the design, scale-up, and optimization of our innovative cell therapy manufacturing processes. This essential role involves leading late-stage process development for cell therapies and creating global technical standards to ensure cost-effective production from early development stages to commercialization.
The successful candidate will be responsible for building and overseeing a multi-site organization dedicated to innovation and compliance, ensuring adherence to all relevant regulations. You will work closely with cross-functional teams, including R&D, Quality, Manufacturing, and Regulatory Affairs, to develop effective process engineering solutions.
Ideal candidates should hold a Ph.D. or Master's degree in a relevant field, with a strong foundation in process engineering within the biotechnology or pharmaceutical sectors. A focus on cell therapy or biologics, coupled with a minimum of 10 years of leadership experience managing high-performing teams, is essential. Experience in cell therapy manufacturing, process design, scale-up, and optimization is crucial.
Key requirements include expertise in GxP compliance, data integrity, and a diversified experience in CMC development for cell therapeutics. We seek a leader with an unwavering commitment to patient impact, creativity in problem-solving, and the ability to inspire and guide talented teams.
Hiring Manager Title Vice President of Analytical and Process Development
Travel Percent Less than 10%
Functions