Job at a glance
Job Title: Project Manager – Operational Readiness Job Description This role leads cross-functional operational readiness for a biologics manufacturing site, ensuring that all key workstreams are aligned, integrated, and prepared for successful execution. The Project Manager focuses on scope, schedule, risk, governance, coordination, and issue resolution across functions such as Manufacturing, Engineering, Process Development, Supply Chain, and Quality Control.
This position influences and drives delivery across teams without direct people or budget management responsibility, providing strategic guidance to de-risk and optimize overall project execution. Responsibilities Lead the definition of project scope for Operational Readiness workstreams, including Manufacturing, Engineering, Process Development, Supply Chain, Quality Control, and related functions.
Develop detailed execution strategies, integrated project schedules, and comprehensive risk registers for operational readiness activities. Integrate and actively facilitate the day-to-day execution of multiple workstreams, ensuring alignment on priorities, milestones, and interdependencies. Plan, lead, and facilitate team meetings, execution forums, and cross-functional sessions to track progress, resolve issues, and maintain momentum.
Represent operational readiness workstreams in appropriate governance forums, providing clear updates, risk assessments, and recommendations. Liaise closely with other project managers to ensure effective, integrated project delivery across construction, commissioning, qualification, and operations. Closely manage schedule performance, monitor critical path activities, and provide timely status updates and insights to management.
Ensure internal alignment of operational readiness schedules and external alignment with construction, commissioning, and qualification workstreams. Provide strategic guidance on overall project delivery to de-risk execution, optimize sequencing, and support on-time, compliant start-up of operations. Proactively identify, manage, and mitigate risks, maintaining the risk register and escalating issues when appropriate to keep objectives and deliverables on track.
Lead and facilitate cross-functional workshops to ensure project alignment, address project challenges, identify gaps, and advance site strategy. Support inspection readiness and audit preparation activities by coordinating with Quality, Manufacturing, and other operational functions. Collaborate with technology and operations teams to ensure manufacturing and operations systems are ready, integrated, and aligned with operational needs.
Operate as a project leader without direct people or budget management, influencing and coordinating across diverse stakeholder groups to achieve project goals. Essential Skills Strong experience in biologics drug substance manufacturing operations, ideally including upstream and/or downstream operations. Demonstrated knowledge and experience in biopharma operations, including GMP and inspection readiness.
Experience supporting audits and regulatory inspections in a biopharma or biologics manufacturing environment. Proven ability to support and coordinate across operational functions such as Quality Control, Process Development, Engineering, and Supply Chain. Knowledge and experience with Commissioning and Qualification (C&Q) activities for manufacturing facilities and systems. Proven track record leading complex, integrated project workstreams with responsibility for scope, schedule, risk, and governance.
Demonstrated ability to manage schedules, dependencies, and risks across multiple cross-functional teams. Experience facilitating execution forums, governance meetings, and cross-functional workshops. Ability to drive delivery and influence outcomes without direct authority over teams or budget. Working knowledge of manufacturing support systems such as MES, PI, and DeltaV. Working knowledge of operations support systems su