Product Introduction; NPI) Lead

Using your strong drug product (DP) technical skills, you will ensure the successful introduction and technology transfer of late-phase and commercial drug products to Middletown, Delaware site. This includes ensuring the on-time-in-full (OTIF) execution and supply of technical, registration, clinical, stability, PPQ, and commercial launch batches.

You will be a key contributor of the NPI team, guiding project managers, technical leads, and cross-functional teams to seamlessly transition products from development or external sites into clinical and commercial manufacturing at the Middletown facility.

Provide NPI and technical leadership for late-phase and commercial-scale production of drug products

Technical support and leadership are realized in the form of (but not limited to):

• Leading the end-to-end technology transfer process (oral solid dosage experience is a must; injectable experience is a plus) from internal development sites, client sites, or third-party facilities into the Middletown site.
• Selection, evaluation, and scaling of process technology, tooling, and methods.
• Development, determination, and optimization of critical process parameters (CPPs) and critical quality attributes (CQAs).
• Enabling, execution, and troubleshooting of production batches.
• Providing technical working instructions and guidance for various manufacturing technologies to ensure production operations comply with cGMP policies and satisfy the highest safety standards.
• Supporting complex deviations by leveraging technical expertise, manufacturing experience, and formal investigation skills.
• Providing technical training and seminars to personnel in other departments to promote the successful adoption of new products and technologies.

Responsible for the successful completion of all DP transfer projects

• Working with the NPI team members and cross-functionally across the site (TO, Production, QC, QA, Supply Chain, Engineering, etc.) to ensure the on-time completion of all DP transfer and NPI projects.
• Responsible for the on-time start of bulk manufacturing and packaging batches.
• Responsible for the on-time delivery of technical, registration, clinical, stability, and commercial batches.

Accountable for the good relationship with clients

• Prior to and during the awarding of a project, act as the main site contact for the client for NPI. You will reflect the WuXi values, providing prompt and frequent interaction, as well as a positive can-do attitude.
• During the project, find solutions that work for the client by knowing what is important to them and understanding the site’s capabilities, capacities, and strengths.
• Proactively identifying and communicating technical, quality, and business risks appropriately, while offering robust mitigation strategies.

Team mentor and technical leadership

• Support, mentor, and develop the NPI team to achieve an environment of personal accountability and trust.
• Do the right thing (be effective): align with site leadership and participate in setting the strategy and priorities for the NPI team, ensuring alignment with the site's growth phase.
• Doing it right (be efficient): manage NPI initiatives and projects by setting and tracking goals and tasks. Continuously improve NPI business processes, tools, and templates.
• Support the team delivery of proactive priority and daily activity of the team (planning communication, team organization, control, checking of defined targets).
• Ensure standard processes are sufficiently defined and documented. KPIs are implemented and monitored; actions are prioritized to ensure KPIs are on target.
• Ensuring roles and responsibilities are clear across matrixed project teams.

Validation & Commercial Readiness

• Support process validation (PPQ) strategy and execution in collaboration with TO and Production teams.
• Support Continued Process Verification (CPV) and commercial launch readiness activities.
• Ensure regulatory inspection readiness, acting as a Subject Matter Expert (SME) during Pre-Approval Inspections (PAI).

Experience / Education

• Bachelor’s degree or above in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related scientific/engineering discipline.
• 10-15+ years of experience in the pharmaceutical industry in a technical operation, R&D, MS&T, or NPI management position.
• 3+ years of experience focusing on Drug Product processes, technology transfer, and scale-up.

Knowledge / Skills / Abilities:

• Familiar with late-phase and commercial drug product…