Chief NPI Architect – Drug Product & Tech Transfer

WuXi Chemistry; Town of Middletown (NY); Presencial; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

WuXi Chemistry in Middletown, DE, seeks a Director of New Product Introduction to lead tech transfer for late-stage and commercial drug products. You will mentor an NPI team, coordinate cross-functional groups, and ensure on-time, in-full product introductions to the manufacturing site.

Responsibilities include end-to-end technology transfer, client liaison for NPI, and oversight of PPQ and CPV activities, with a focus on regulatory readiness and cGMP compliance.

Formación

• Bachelor's degree or above in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or related discipline.
• 10-15+ years of pharmaceutical industry experience in Technical Operations, R&D, MS&T, or NPI management.
• 3+ years of leadership experience focusing on Drug Product processes, technology transfer, and scale-up.
• Deep understanding of late-phase and commercial drug product manufacturing requirements.
• Working knowledge of FDA, EMA, cGMP, ICH guidelines, and SUPAC.
• Excellent communication, stakeholder management, and matrix leadership skills; PMP certification a plus; fluent in English.
• Thrives in a fast-paced, dynamic environment and navigating ambiguity of a growing site.

Responsabilidades

• Lead end-to-end technology transfer from internal development sites, client sites, or third-party facilities into the Middletown site.
• Ensure OTIF delivery of technical, registration, clinical, stability, PPQ, and commercial launch batches.
• Serve as primary site contact for clients regarding NPI, building relationships through proactive communication and risk mitigation.
• Mentor and develop the NPI team; align with site leadership on strategic priorities and KPIs.
• Collaborate with Technical Operations and Production on PPQ strategy and CPV; support regulatory readiness (PAI).

Conocimientos

Communication

Stakeholder management

Matrix leadership

Project management

Regulatory knowledge

Drug product tech transfer

Fluent English

Educación

Bachelor's degree or higher in Pharmaceutical Sciences / Chemical Engineering / Chemistry

Descripción del empleo

WuXi Chemistry in Middletown, DE, seeks a Director of New Product Introduction to lead tech transfer for late-stage and commercial drug products. You will mentor an NPI team, coordinate cross-functional groups, and ensure on-time, in-full product introductions to the manufacturing site.

Responsibilities include end-to-end technology transfer, client liaison for NPI, and oversight of PPQ and CPV activities, with a focus on regulatory readiness and cGMP compliance.