Project Manager – NPI
On-site · Philadelphia, Pennsylvania, United States
Job Summary
Project Manager – NPI role focused on end-to-end management of assigned new product introduction programs from award through commercialization. Key duties include maintaining project plans and RAID logs, coordinating cross-functional teams (Engineering, QA, Operations, Supply Chain), leading weekly meetings, ensuring compliance with cGMP and FDA requirements, delivering client status updates and steering committee materials, guiding technology transfer and validation activities (OQ/PQ/PPQ/PLT), and managing timelines, budget, and scope. The position involves frequent collaboration with clients and internal teams, travel as needed, and adherence to the NPI Playbook and regulatory standards. The ideal candidate has a technical degree, 4+ years in pharmaceutical project management, strong communication, and experience with Smartsheet/M365, with PMP/PRINCE2 and tech transfer/validation exposure preferred.
Required Qualifications
- Bachelor’s degree in a technical, engineering, or science discipline
- 4+ years of experience in pharmaceutical project management, preferably within a CDMO or contract manufacturing environment
- Sound working knowledge of cGMP and FDA regulatory requirements
- Experience managing technical projects including integrated timeline management, risk identification, escalation, and resolution
- Proficiency with Smartsheet or equivalent project management platforms, and Microsoft 365 suite
- Strong communication skills with the ability to interact effectively with internal cross-functional teams and external clients
- Ability to manage multiple concurrent projects with competing priorities and deadlines
- Strong problem-solving skills with an analytical, detail-oriented approach
- Ability to influence and drive accountability across cross-functional teams without direct authority
- Dependability, reliability, integrity, and attention to detail
- Customer-centric mindset with a commitment to quality, ethics, and professionalism
- PMP, PRINCE2, or equivalent project management certification (preferred)
- Experience with tech transfer, process validation (PLT/PQ/PPQ), or commercial manufacturing readiness activities (preferred)
- Understanding of drug product manufacturing processes, equipment, and packaging operations (preferred)
- Experience working directly with pharmaceutical clients as the primary operational point of contact (preferred)
- Familiarity with stage-gate or phase-gated project management methodologies in a GMP manufacturing environment (preferred)
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