Required Skills & Experience
→ Bachelor's degree in Engineering, Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline. → 8+ years of experience within biologics, biotechnology, pharmaceutical manufacturing, MSAT, process engineering, technical operations, or technology transfer environments. → Demonstrated experience leading complex technical projects within GMP-regulated manufacturing organizations. → Strong understanding of biologics manufacturing processes and commercialization activities. → Experience managing cross-functional initiatives involving Quality, Manufacturing, MSAT, Supply Chain, and Technical Operations. → Experience coordinating and driving change controls, deviations, CAPAs, and manufacturing readiness activities. → Ability to operate independently within global organizations and influence stakeholders across multiple sites.
Nice to Have Skills & Experience
→ Experience supporting monoclonal antibodies or other large molecule biologic products. → Technology transfer experience from development into commercial manufacturing. → Experience supporting PPQ, validation, launch readiness, and commercialization programs. → Familiarity with COMET or comparable quality management/change control systems. → Experience supporting global manufacturing networks and international stakeholders. → PMP certification or equivalent project management training.
Job Description
Position Summary We are seeking an experienced Technical Project Manager to support the Global MSAT Launch & Grow organization. This individual will partner with cross-functional teams to drive activities associated with late-stage development, technology transfer, process validation, launch readiness, and commercial manufacturing operations for complex biologic products. The ideal candidate brings a combination of technical manufacturing expertise and project leadership experience, allowing them to independently manage critical deliverables while coordinating across R&D, Manufacturing, Quality, Supply Chain, and Technical Operations teams. This role will play a key part in ensuring successful product commercialization and operational readiness across global manufacturing sites.
Key Responsibilities
→ Lead and coordinate technical projects supporting product launches, technology transfers, process validation activities, and commercial manufacturing readiness. → Drive project execution across cross-functional stakeholders, ensuring alignment on timelines, risks, action items, and key deliverables. → Manage and shepherd change controls within COMET from initiation through closure, coordinating content development, stakeholder reviews, approvals, and implementation activities. → Support PPQ, launch, and commercialization activities by ensuring technical deliverables are completed on schedule and risks are proactively addressed. → Facilitate communication between R&D, MSAT, Manufacturing, Quality, Regulatory, and Supply Chain teams to support seamless product transfers and launch execution. → Track project milestones, critical path activities, and escalation items while providing clear status updates to leadership. → Identify and mitigate risks associated with manufacturing readiness, technical transfers, process changes, and launch activities. → Support development and execution of site readiness plans, technical implementation strategies, and operational transition activities. → Serve as a technical liaison across global manufacturing locations, including support of initiatives within Cork, Ireland and Leiden, Netherlands.