The Principal Scientist, Engineering will advance and commercialize biologics and vaccines pipeline programs, driving excellence in process characterization, scale up, transfer and process validation activities.
Requirements
- Execute and provide oversight to biologics product and process design, development, characterization, technology transfer, and robust commercial validation
- Lead and/or serve on cross-functional biologics drug product (DP) working groups and manage DP activities through filing and Process Performance Qualification (PPQ)
- Ensure commercialization programs meet requirements related to science, quality, reliability, schedule, and cost
- Drive strategic initiatives in the department and with partner groups to enable more efficient and rapid commercialization of innovative products
- Provide mentorship, technical oversight, and strategic guidance to employees
- Develop a process and product development plan and influence decisions related to primary packaging and combination product design
- Responsible for the design and execution of DP development and commercialization studies, new product introduction, and process validation at commercial sites
- Ensure fit-for-purpose scale-down models are developed and employed and establish and validate platform engineering and scientific models for sterile product and process commercialization
- Innovate and drive best practices for commercial site tech transfer, facility fit, and development of the DP control strategy
Benefits
- Medical, dental, vision healthcare, and other insurance benefits (for employee and family)
- Retirement benefits, including 401(k)
- Paid holidays, vacation, and compassionate and sick days
