Our client, a leading pharmaceutical manufacturing company, is hiring a NPI Manager with a focus on Shift work. The candidate must be willing to provide 24/7 support for 1-2 weeks at a time. This is a 12 month contract.
This role provides process development support for new product introductions (NPI) and lifecycle management (LCM) changes within biologics drug product manufacturing. The candidate will serve in a Shift Lead capacity, providing process development oversight while supporting engineering runs, process performance qualifications (PPQs), and commercial manufacturing in vial and syringe suites. The position also involves troubleshooting, technical support, and continuous improvement initiatives as part of a global process development organization. Moderate international travel may be required.
Key Responsibilities
Lead process development support for NPI projects and serve as the subject matter expert on the manufacturing floor.
Support product transfer projects, including line characterization, engineering studies, PPQs, and regulatory approval activities.
Provide technical solutions for drug substance handling, formulation, filling, lyophilization, inspection, and transportation of parenteral products.
Participate in process validation, quality system documentation, and cross-functional teams to ensure compliance with cGMP and regulatory requirements.
Lead continuous improvement initiatives to optimize NPI processes and support commercial drug product manufacturing.
Key Requirements:
Bachelor’s or Master’s degree in science, engineering, or related discipline.
Significant experience with technology transfer activities.
Knowledge of cGMPs, global regulatory requirements, and quality systems for drug product manufacturing and validation.
Strong problem-solving, project management, and communication skills, including leading cross-functional teams.
Demonstrated application of engineering and scientific principles to process development, troubleshooting, and validation (sterile processing, freeze-thaw, filtration, mixing, filling, lyophilization).
Ability to participate in 24/7 operational support for short periods and manage multiple initiatives simultaneously.