Responsibilities
o Creatively apply engineering design principles to hardware, software, and materials to deliver the next generation platform for sustainable cell therapy processes
o Work with stakeholders to define user requirements for technology and materials
o Survey landscape of existing solutions with probability of meeting user requirements
o Employ vendors to create custom solutions in areas of unmet need
o Contribute to project plans, design drawings, and equipment risk assessments
o Author study protocols, reports, procedures, and batch records
o Design and execute studies to test equipment and material prototypes and address risks
o Present experimental results to colleagues and cross-functional leadership
o Drive design iteration through testing and analysis feedback loop
o Participate in factory acceptance testing and review / approve turnover package
o Perform process characterization to generate data for use in regulatory filings
o Write SOPs and support technology transfer to clinical and commercial manufacturing
o Manage a small team of engineers to drive projects and provide career development
o Provide technical leadership for troubleshooting in a laboratory setting
o Interpret department strategy into an actionable plan for team members
o Contribute to IP portfolio in finding solutions for sustainable manufacturing platforms
ยท Skills / Knowledge
o BS, MS, or PhD in bioengineering, chemical engineering, biotechnology, immunology, or relevant technical degree
o 5+ years of experience in a relevant field
o 3+ years of experience managing a technical team
o Familiarity with biopharmaceutical regulations for various regulatory bodies such as the FDA and EMA
o Experienced with design of experiments, study prioritization, and risk management
o Familiarity with general mammalian cell culturing and aseptic techniques
o Familiarity with GLP and GMP regulations
o Highly experienced with statistical methods for engineering and basic sciences
o Ability to adapt and function in a dynamic and cross-functional environment
o Self-motivated, technically driven, and willing to take on duties outside of general role
o Contribute to maintenance of a safe and collaborative work environment in accordance with policies / procedures / regulations
o Excellent verbal, written, and presentation skills
o Ability to interpret and communicate relevant developments in academic literature
o Creative thinking skills to challenge current understanding and help define process improvement and optimization opportunities