Senior Scientist, Cell Therapy Process Development
The Senior Scientist, Cell Therapy Process Development position plays a key role in implementing and optimizing processes related to the development of cellular therapies involving primary cells and stem cells. This individual will work independently to optimize cell culture manufacturing approaches and protocols, develop assays, and integrate cell culture platforms and analytical technologies into a GMP compliant workflow for late-stage development. We are seeking an individual with the breadth of professional experience and drive to work effectively with both internal and external partners in a highly matrixed and cross-functional organization.
Essential Duties and Responsibilities:
- Develop and refine cell manufacturing processes for clinical and commercial manufacturing
- Supports technology transfers, regulatory filings, interactions with CMOs and CROs
- Develop and perform analytical assays to understand for process development needs
- Participates in internal and external collaborations to evaluate and implement new process technologies
- Maintains up to date knowledge of cell therapy manufacturing trends and provides recommendations regarding manufacturing process improvement initiatives
- Authoring of SOPs, protocols, and technical reports
- Complies with all applicable laws and Company policies regarding health, safety, and environment.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and Experience:
- PhD in Life Sciences, bio-engineering, or related discipline with minimum 3 years of relevant industry experience or Master’s degree with 5 years of industry experience
- Management experience
- Demonstrated cell production technology development experience in a bio-pharmaceutical setting
- Demonstrated experience working with interdisciplinary and cross-cultural teams
- Ability to communicate effectively with a diverse audience of scientists, engineers, regulatory specialists, and business professionals
- Ability to meet deadlines, adapt to rapid changes, and work in a fast-paced team environment
- Ability to work effectively both independently and with other team members.