Sr. Scientist

About the role

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 process using Quality by Design principle and multivariate approaches. This position will develop and integrate cell culture platforms into a GMP compliant workflow for late-stage development.

Responsibilities

• Develop and optimize cellular therapy manufacturing process involving primary mammalian cells and stem cells
• Perform process development studies by implementing Design of Experiment approaches, and statistical analysis to make data-driven decisions around implementation of new materials or process
• Develop, optimize and refine cell manufacturing processes for clinical and commercial manufacturing
• Proactively pursues experience with later development stages of cell manufacturing processes for clinical and commercial manufacturing
• Supports technology transfers and quality documents, regulatory filings, interactions with CMOs and CROs
• 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, technical reports, regulatory documents
• Complies with all applicable laws and Company policies regarding health, safety, innovation and environment

Qualifications and Education

• PhD in Life Sciences, bio-engineering, or related discipline with 5+ years of relevant industry experience
• Experience with biological products is critical, experience specifically with cell therapy technologies is preferred
• Deep technical understanding of cell production technology and cell process development
• Strong experience in cell therapy process development using multivariate studies using Quality by Design principles
• Experience with JMP software or equivalent
• Demonstrated cell production technology development experience in a cell therapy setting
• Must have strong initiative and drive to complete challenging tasks and learn new technologies
• Able to meet deadlines, adapt to rapid changes, and work in a fast-paced team environment
• Ability to work effectively with both independently and with other interdisciplinary and cross-cultural team of scientists, engineers, quality and regulatory specialists, and business professionals
• Intermediate proficiency of MS Office products