OverviewAbout the Role: Are you a seasoned pharmaceutical technical leader looking to make a significant impact at a growing manufacturing site? We are seeking an
Associate Director / 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.
ResponsibilitiesTechnical 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.
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.
