Senior/Principal Engineer, Cell Process Development

Job Title: Senior/Principal Engineer, Cell Process Development

Job Number: 32470

Location: , 

Job Description

Responsibilities

 Contribute to the setup and organization of cell therapy process development
capabilities
 Oversee day-to-day activities within the Cell Process Development labs including onboarding and training
of new staff
 Serve as a cell culture and process development subject matter expert in both internal
(interdepartmental) and external (CDMO, material & equipment suppliers, etc) settings
 Design and execute process development, characterization and phase-appropriate validation studies, as
well oversee the transfer of processes between R&D, Tech Ops, and external partners
 Support development of manufacturing equipment for cell therapy products including hardware, software,
and single-use disposable design elements and user-requirements
 Author and review technical documents, including but not limited to study protocols, process
development and validation reports and process/manufacturing sections of regulatory documents.
 Represent the organization externally at meetings (professional associations, with regulatory bodies, etc)

Required Skills

 A degree in Biological or Chemical Engineering, Molecular or Cellular Biology, Biotechnology or related
discipline and at least 6 years of relevant process development or MSAT experience in the CAR-T or
cell therapy space.
 Hands on experience with cell processing technologies, closed processing systems (e.g.,
Welders/Sealers, CliniMACS, LOVO, Sefia/Sepax, G-Rex), and single-use disposables
 Working knowledge of analytical tools commonly utilized in cell therapy manufacturing including
fundamental understanding of cell biology principles such as sub-population types, cell differentiation,
and phenotypic markers
 Experience interacting with external partners (e.g, material & equipment suppliers, CDMOs) and
performing technology transfers (preferred but not required)
 Experience drafting CMC CTD sections for INDs (preferred but not required)
 Strong organizational & problem-solving skills, with the proven ability to collaborate in a dynamic team
environment
 Strong scientific reasoning, problem-solving, engineering, and applied statistics skills, including the
ability to break down complex problems into manageable hypothesis
 Proficiency in using Microsoft Word, Excel, Power Point and data analysis/presentation software such
as JMP and/or GraphPad
 Excellent interpersonal, verbal and written communication skills
 Situational Awareness & Sense of Humor