Operational Readiness Manager – Mammalian Manufacturing
On-sitePortsmouth, New Hampshire, United States
Job Summary
Define and champion the comprehensive operational readiness strategy from initial demolition through final commercial validation. Actively evaluate facility layouts and automated systems to forecast alignment with GMP workflows post-handoff. Serve as the on-site center of gravity, facilitating workshops to synchronize Engineering, QA/QC, Construction, and Capital Teams. Manage and reconcile the $25M operational readiness budget while leading resource planning matrices. Proactively identify execution barriers and technical dependencies to ensure a seamless transition into routine commercial GMP operations. Bridge the gap between engineering design and long-term commercial sustainability for a facility expansion doubling local mammalian manufacturing capacity.
Required Qualifications
- 10+ years of direct, job-related experience in GMP manufacturing
- extensive early-stage/start-up asset execution for pharmaceutical or biotechnology facilities regulated by the FDA or EMA
- Proven background in organizational design—specifically demonstrating a structured methodology for how to build, scale, and upskill manufacturing teams from scratch
- Exceptional capability to unite varied operational perspectives, manage high-ambiguity project environments, and proactively drive consensus across highly specialized technical matrix teams
- Deep working knowledge of current mammalian cell culture bioprocessing
- technical transfer frameworks
- validation principles
- life science regulatory expectations
- Bachelor's Degree in a Life Science, Engineering, Business Management, or a related scientific/technical discipline
Desired Qualifications
- PMP (Project Management Professional) certification from the Project Management Institute (PMI)
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