New Product Introduction (NPI) Director

WuXi AppTec Group; Town of Middletown (NY); On-site; USD 180,000 - 240,000; Full time

Job summary

WuXi AppTec Group in Middletown, DE, is seeking a Director of New Product Introduction to lead the tech transfer of late-stage and commercial drug products into our facility. You will guide cross-functional teams, ensure OTIF execution, and mentor the NPI group to deliver robust, compliant processes.

The role requires 10–15+ years in pharma manufacturing, strong leadership, deep DP knowledge, regulatory savvy, and excellent communication.

Qualifications

• Education: Bachelor’s degree or above in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related scientific/engineering discipline.
• Experience: 10–15+ years in Technical Operations, R&D, MS&T, or NPI management.
• Leadership: 3+ years leading Drug Product processes, tech transfer, and scale-up.
• Technical Knowledge: Deep understanding of late-phase and commercial drug product manufacturing requirements.
• Regulatory Knowledge: Knowledge of FDA/EMA, cGMP, ICH, and SUPAC.
• Skills: Strong communication, stakeholder management, matrix leadership; PMP a plus; fluent English.
• Work Style: Thrives in fast-paced, dynamic environment and can navigate ambiguity.

Responsibilities

• Lead end-to-end technology transfer from internal development sites or client/third-party facilities into the Middletown site.
• Coordinate and optimize OS D/ injectables related tech transfer and scale-up efforts.
• Develop CPPs and CQAs; troubleshoot deviations and ensure cGMP compliance and safety.
• Ensure on-time delivery of technical, registration, clinical, stability, PPQ, and commercial launch batches.
• Manage client relationships and align site capabilities with client needs for robust solutions.

Skills

Communication

Stakeholder management

Matrix leadership

Project management

PMP certification

English fluency

Education

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

Job description

Overview

About the Role: Are you a seasoned pharmaceutical technical leader looking to make a significant impact at a growing manufacturing site? We are seeking a Director of New Product Introduction (NPI)to join our team in Middletown, Delaware.

In this critical leadership role, you will leverage your deep Drug Product (DP) technical expertise to ensure the successful technology transfer and introduction of late-phase and commercial drug products to our facility. You will lead and mentor a dedicated NPI team, guiding cross-functional groups to seamlessly transition products from development or external sites into clinical and commercial manufacturing, ensuring on-time-in-full (OTIF) execution.

Responsibilities

Technical Leadership & Tech Transfer

• Lead the end-to-end technology transfer process from internal development sites, client sites, or third-party facilities into the Middletown site.
• Experience with Oral Solid Dosage (OSD) is a must; experience with injectables is a plus.
• Select, evaluate, and scale process technology, tooling, and methods.
• Develop and optimize critical process parameters (CPPs) and critical quality attributes (CQAs).
• Troubleshoot production batches, support complex deviations, and provide technical guidance to ensure cGMP compliance and high safety standards.

Project & Client Management

• Ensure the on-time delivery of technical, registration, clinical, stability, PPQ, and commercial launch batches.
• Act as the primary site contact for clients regarding NPI, fostering strong relationships through proactive communication, risk mitigation, and a “can-do” attitude.
• Understand client needs and align them with the site’s capabilities and strengths to deliver robust solutions.

Team Leadership & Strategy

• Guide, mentor, and develop the NPI team, fostering an environment of trust and personal accountability.
• Align with site leadership to set strategic priorities, drive continuous improvement in NPI business processes, and establish/monitor team KPIs.
• Ensure roles and responsibilities are clear across matrixed project teams.

Validation & Commercial Readiness

• Collaborate with Technical Operations and Production teams to support process validation (PPQ) strategy and execution.
• Support Continued Process Verification (CPV) and commercial launch readiness.
• Act as a Subject Matter Expert (SME) during Pre-Approval Inspections (PAI) to ensure regulatory readiness.

Qualifications

• Education:Bachelor’s degree or above in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related scientific/engineering discipline.
• Experience:10-15+ years of pharmaceutical industry experience in Technical Operations, R&D, MS&T, or NPI management.
• Leadership:3+ years of leadership experience with a strong focus on Drug Product processes, technology transfer, and scale-up.
• Technical Knowledge:Deep understanding of late-phase and commercial drug product manufacturing requirements.
• Regulatory Knowledge:Working knowledge of global regulatory requirements (FDA, EMA, etc.), cGMPs, ICH guidelines, and best practices (including SUPAC).
• Skills:Exceptional communication, stakeholder management, and matrix leadership skills. Excellent organizational and project management skills (PMP certification is a plus). Fluent in English.
• Work Style:Thrives in a fast-paced, dynamic environment and is comfortable navigating the ambiguity of a growing site.

Why Join Us?This is a unique opportunity to shape the NPI strategy and drive commercial success at a rapidly growing facility. If you are passionate about bringing life-changing products to market and leading high-performing technical teams, we want to hear from you!

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.