Senior Process Engineer, Technology Development


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