New Product Introduction (NPI) Lead

Overview

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.

Responsibilities

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).

Qualifications

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 manufacturing requirements (oral solid dosage and/or sterile injectables).
• Working knowledge of global regulatory requirements (FDA, EMA, etc.), cGMPs, ICH guidelines, and best practices including SUPAC.
• Strong leadership skills, including coaching, motivating teams, and leading without direct authority in a matrixed environment.
• Exceptional communication and stakeholder management skills.
• Enjoys a fast-paced, dynamic work environment and is comfortable navigating the ambiguity of a growing site.
• Excellent organizational and project management skills (PMP certification is a plus).
• Fluent in English.

 

 

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.