INTL - Technical Project Manager - MSAT Launch & Grow

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.

Skills and Requirements

→ 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. → 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.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].