CMC Project Manager
CMC Project Manager
As a key member of Lentigen Technology, you will have the opportunity to manage multiple large projects simultaneously with our GMP manufacturing, Process Development and Research and Development Teams. The unique duties of this position will allow you to interact in a collaborative environment where your main focus will be driving the definition of our CMC strategy, provide support through all product development stages (Process and Analytical Development, Process Transfer, GMP Manufacturing and Testing, Process and Analytical Validation and Commercial Manufacturing) across CMC functions and departments, enabling the project delivery in line with time, financial and quality requirements. Furthermore, you will work alongside departmental heads in order to identify resources needed and assign individual responsibilities. Overall, your exceptional management skills will guarantee the successful completion of team tasks and goals in a timely manner, which ultimately will drive Lentigen Technology’s continued and growing success.
- You hold a M.S. or B.S. in a science related disciple; such as Biology, Chemistry, Biotechnology, Genetics, Genomics, Pharmaceuticals, Engineering, etc.
- You have at least 5 years’ related experience in the biotechnology or pharma industry with a primary focus on process development, GMP manufacturing operations and other related CMC activities
- Demonstrated experience managing CMC project deliverables, scope, and timeline to ensure the project remains on schedule and within scope
- You previously worked in a biotechnology research and cell therapy development environment or a GMP facility
- Your communication skills allow you to confidently give presentations, partner with stakeholders and department heads, and present clear performance expectations
- In any situation, you are able to maintain a mentality of flexibility
Lentigen Technology Inc., a Miltenyi Biotec company, is transforming and progressing. Our culture is one of bold scientific innovation. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.
At Lentigen, we support the development and commercialization of novel treatments for human disease through the utilization of Lentiviral Vectors. We hold this widely recognized and clinically relevant method for delivering genetic materials into cells in order to modulate their function as core strength of our company. We are scientists, engineers, physicians, support specialists, and more – all dedicated to improving scientific understanding and impacting human lives. At our Gaithersburg campus we strive to find solutions to both the technical and conceptual barriers to the implementation of gene therapy approaches for the treatment of human disease.
Lentigen Technology Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity