New Product Introduction (NPI) Specialist – Manufacturing

Role Summary

The New Product Introduction (NPI) Specialist will join the RTP Bio Manufacturing team to ensure new products are successfully introduced to the manufacturing facility. This highly visible role drives timelines, coordinates cross-functional stakeholders, and enables operational readiness to support on-time startup for new products.

Responsibilities

• Support cross-functional project teams responsible for introducing new products into manufacturing operations.
• Manage and execute detailed project plans, timelines, and deliverables for NPI initiatives, ensuring milestones are met on time and within budget.
• Track and drive completion of key deliverables required to ensure overall site readiness.
• Present project progress, operational status, and timeline-related risks at appropriate governance forums.
• Identify, assess, and mitigate risks related to operational readiness and new product launches.
• Drive continuous improvement initiatives to enhance NPI processes and reduce time-to-market.

Qualifications

• Required: At minimum 5 years of experience in pharmaceutical manufacturing, process development, or related discipline
• Required: Experience with technology transfer, process validation, and equipment qualification
• Required: Proven ability to work effectively in a deadline-driven, dynamic environment in support of a successful execution of site readiness plan
• Required: Strong knowledge of cGMP, regulatory requirements, and pharmaceutical manufacturing processes
• Required: Demonstrated project management experience, including leading cross-functional teams
• Required: Excellent communication, organizational, and analytical problem-solving skills
• Preferred: Master’s degree in engineering or related STEM field from an accredited college or university
• Preferred: Project Management certification (PMP or equivalent)
• Preferred: Familiarity with Lean Manufacturing and/or Six Sigma methodologies
• Preferred: Proficiency with documentation systems and electronic batch record (EBR) platforms

Education

• Bachelor’s degree in engineering or related STEM field from an accredited college or university (Required)
• Master’s degree in engineering or related STEM field from an accredited college or university (Preferred)