Sr Process Engineer II

Kite Pharma•Frederick, MD

11d•$153,935 - $199,210

About The Position

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Requirements

Technical depth & process expertise in late-stage clinical and commercial T cell and viral vector manufacturing
Leadership without authority across a matrixed, global organization
Ability to establish business processes, drive standardization and governance in complex environments
Excellent interpersonal, verbal and written communication skills, presentation skills, as well as digital literacy
Ability to establish business processes, drive standardization and governance in complex environments
Bachelor's Degree in Engineering, Biotechnology or Life Sciences with at least 8 years of relevant experience in pharmaceutical/biotech manufacturing, process development or process engineering
OR Masters in Engineering, Biotechnology or Life Sciences with at least 6 years of relevant experience in pharmaceutical/biotech manufacturing, process development or process engineering

Nice To Haves

Expertise in process equipment and engineering, technology transfer or pharmaceutical manufacturing experience
Expertise in viral vector manufacturing is a plus
Cell culture, cell therapy or aseptic processing experience
Equipment and/or new technology design, qualification and testing experience in a cGMP environment (IQ, OQ, PQ) including process validation
Experience in Project Management and Project Management Methodology
Strong understanding of GMP environment and change control processes
Experience with investigations and structured problem solving methodologies (e.g., deviations, DMAIC, root cause analysis)
Proactive and willing to accept temporary responsibilities outside of initial job description
Experience in engineering in highly regulated manufacturing environments

Responsibilities

Own and maintain global process documentation, including Process Descriptions, Process Control Strategy, & process FMEAs for multi-site commercial processes
Conduct global change control impact assessments to ensure process consistency across the network
Support the development of a standardized documentation and governance framework to enable lifecycle management and harmonization
Lead high-priority, complex global MSAT projects spanning multiple sites, functions, and jurisdictions
Contribute to Global MSAT project portfolio strategy, prioritization, and execution
Drive cross-functional alignment and ensure reliable execution of network-level initiatives
Lead global investigations across sites to identify root causes and implement sustainable solutions
Develop and implement standard investigation frameworks and playbooks
Ensure adherence to global governance and change management processes to support process harmonization
Act as a site-agnostic process expert, supporting alignment of site activities with network strategy
Partner with Manufacturing, Process Development, and Quality to bridge development and commercial operations
Support process harmonization and implementation of best practices across sites