Manager, Process Engineering

About the role

The Manager, Process Engineering is responsible for leading the Upstream and Downstream Drug Substance Manufacturing (DSM) Process Engineering team and activities from inoculation through bulk fill. This role utilizes technical expertise with process equipment and processes to provide support and direction on technical topics. The Manager applies their leadership experience to oversee and manage a team of experienced and developing engineers supporting operations, technology transfers (TT), and projects on time and within budget. Additionally, the Manager drives site engineering goals and deliverables ensuring the successful manufacturing operations.

Responsibilities

• Fosters and sustains a people-first culture where the team feels valued, respected, and supported through servant leadership
• Implements the strategy for Process Engineering in close collaboration with stakeholders and Large-Scale Business Unit counterparts
• Buils and leads a high-performing Process Engineering team while encouraging a culture that prioritizes continuous learning and development through coaching and mentoring
• Owes departmental operations – budget, systems, workflows, and resource planning to deliver on time and within budget
• Manages a team to lead, develop, and implement technically sound and fit-for-purpose policies and procedures based on current regulations, industry standards, and practices for DSM, process, and TT, and equipment validation
• Promotes and supports the definition of equipment requirements for executing clients’ manufacturing processes
• Seeks to continuously optimize manufacturing processes and equipment to ensure effective use of capacity and minimize costs
• Partners with clients, MSAT, Quality, and Manufacturing on new technology introduction, scale-up, and manufacturability as part of TT, as needed
• Participates in TT stage gate reviews on incoming processes/changes ensuring the change is ready for introduction to manufacturing and manufacturability of the process
• Establishes systems and procedures to enable proactive equipment monitoring, analysis, and reporting
• Functions as the senior leader for client projects, translating complex process data into clear and concise technical explanations and status updates, and supports equipment evaluations and risk assessments
• Provides team support for critical manufacturing investigations and technical oversight of deviations, change controls, corrective and preventive actions (CAPAs)
• Affairs with assessing, communicating, and mitigating key manufacturing equipment risks
• Oversees process engineering, process equipment, instrument care, maintenance, troubleshooting, and data interpretation
• Evaluates team performance, implements measures to improve productivity and engagement, and partners with People & Culture to recruit and retain talent

Requirements

• Bachelor’s degree in engineering or related discipline with 6+ years in an engineering role (4+ in the life science industry); or Master’s degree in engineering or related discipline with 4+ years in an engineering role in the life science industry
• 4+ years of experience managing people
• Prior experience in Greenfield site startup
• Prior experience in cell culture, centrifugation, chromatography, TFF, and depth filtration
• Experience working in a changing, project-driven organization

Preferred Requirements

• Large capital expenditure experience
• Prior experience working in a Greenfield site
• Experience collaborating with global colleagues