Associate Director Cell Therapy Process Development - Research & Development - East Coast
The Genomic Medicine Unit (GMU) CMC group at the company is dedicated to the establishment of best-in-class manufacturing platforms to support development of life-changing advanced cell and gene therapy products, including recombinant AAV vectors, lentiviral vectors and cell therapy products.
Our client is looking for an experienced cell culture development professional with experience in cell therapy process development to join the GMU Cell Therapy Process Development (CTPD) with the mission to develop robust, scalable, and innovative cell culture processes for the company's genomic medicine pipeline.
Job Duties & Responsibilities:
- Lead a team responsible for the development of cell therapy related cell culture processes, and technology transfer to manufacturing sites.
- Makes strong technical, strategic contributions to cross functional development project teams.
- Oversee the process development and scale-up operations, defining scale down models and authoring associated regulatory filing activities.
- Drive innovation to enhance process productivity and quality.
- Present findings and/or results to senior management, external stakeholders, and industry leaders at national/international conferences.
- PhD degree in Biotechnology, Biology/Cell Biology, Biochemistry, Immunology, Chemical Engineering, or related discipline with a minimum of 8 years of relevant experience or a Master's or Bachelor's degree with a minimum of 12 years of relevant experience.
- Experience in the biotech/pharmaceutical industry within a cell culture role.
- Strong background in cell culture and bioprocess engineering (bioreactor operations and scale up technologies).
- Minimum of 5 years of experience managing direct reports or project teams.