We are seeking a highly capable and motivated candidate to provide cell process development-related scientific and engineering support for CAR T product candidates from early development through commercial using an established manufacturing platform. This individual will be responsible for developing and successfully implementing innovative new technologies into the T cell therapy manufacturing process for expansion platforms. He/she will be also be accountable for solving any platform-related challenges and establishing alignment of key expansion platform strategies. Strong application of previous experience and engineering fundamentals to process design is a must. This position is a hands-on, laboratory-based role that will interact extensively with the other individual project teams and technology centers of excellence in order to build a cohesive expansion platform process.
Responsibilities will include, but are not limited to, the following:
- Independently design and execute complex experiments to assess impact and feasibility of new processing technologies transferred from various technology groups.
- Organize, record and maintain large experimental data sets across multiple studies. Critically analyze and interpret data using statistical methods.
- Support any deviations or CAPAs related to the expansion platforms. Author and revise technical documents including master batch records, process development processing templates and bill of materials.
- Interface with operational teams to facilitate change requests and implementation. Maintain and spread knowledge of current scientific literature and apply key concepts to project activities and plans.
- Collaborate cross functionally with other teams to advance joint programs. Provide guidance and mentorship to less experienced engineers on the team.
- Ensure proper operation and perform routine maintenance of all laboratory equipment. Define/maintain a safe work environment in accordance with policies/procedures/regulations.
- B.S. in Biochemical, Chemical or Biomedical Engineering or Biology related discipline with 6-8 years of relevant experience or M.S. with 4-6 years of relevant experience
- Must have excellent organization skills and ability to handle multiple tasks
- Highly motivated, willingness to acquire new skills and ability to work with minimal supervision
- Must have strong engineering or scientific knowledge appropriate for cellular process development
- Mastery of mammalian cell culture and aseptic technique with strong laboratory skills
- Experience working in a regulated environment and preparing regulatory documents
- Excellent verbal and written communication skills
- Interpersonal and leadership skills to work with teams in different functions and organizations