Specialist Manufacturing

Job Title:

Specialist Manufacturing New Product Introduction

Job Description

This Specialist Manufacturing New Product Introduction role focuses on leading new product introduction (NPI) activities within a regulated, cGMP manufacturing environment. You drive NPI project planning and execution, coordinate cross-functional teams, and ensure all activities comply with GMP and regulatory requirements. The role is fully onsite, aligned with standard business hours, and requires strong project management, communication, and problem-solving skills with a quality-first mindset.

Responsibilities

+ Develop, maintain, and implement comprehensive NPI project plans, taking accountability for project scope, schedule, and risk management.

+ Lead matrixed, cross-functional teams through influence to achieve NPI project milestones and deliverables.

+ Resolve project and operational issues in a timely manner, escalating cross-functional concerns to appropriate levels of leadership when needed.

+ Own and manage change controls in Trackwise, ensuring records are complete, accurate, and compliant with GMP regulatory procedures using a Right-First-Time approach.

+ Proactively lead cross-functional team meetings to ensure NPI projects and related business cases execute according to schedule.

+ Communicate succinctly and clearly, verbally, in writing, and through presentations to peers and leadership.

+ Engage closely with Quality and Regulatory teams to ensure alignment, compliance across the network, and support for regulatory agency submissions during NPI delivery.

+ Hold supporting functions accountable for completing NPI project tasks, documenting lessons learned, and presenting key findings to management when appropriate.

+ Review protocols for manufacturing activities and partner with Quality Assurance to ensure GMP standards are maintained in accordance with current SOPs, batch record documentation, and licenses.

+ Identify improvement opportunities within the organization and take proactive steps to build consensus and implement agreed changes.

+ Conduct purposeful presence Gemba walks in the manufacturing plant to identify process improvement opportunities related to NPIs and lifecycle management strategies.

+ Monitor and report on team and plant metrics to provide visibility into operations and key deliverables.

+ Represent the NPI team at plant-wide and network-wide forums as needed, acting as a key liaison for manufacturing initiatives.

Essential Skills

+ Strong project management capabilities, including planning, scheduling, and risk management for complex cross-functional initiatives.

+ Ability to build and maintain effective cross-functional relationships and lead matrixed teams through influence.

+ Excellent communication skills, able to articulate and communicate problem statements clearly to technical staff and management.

+ Quality-first mindset with a commitment to GMP compliance and Right-First-Time execution.

+ Independent problem-solving skills, with the ability to work autonomously and make sound decisions in a fast-paced environment.

+ Strong organizational skills and attention to detail in managing documentation, change controls, and project deliverables.

+ Technical writing skills, able to present complex issues and solutions concisely and clearly.

+ Experience working in regulated environments such as cGMP manufacturing.

+ Ability to manage change and demonstrate flexibility in response to evolving project and business needs.

+ Collaborative, team-oriented approach with the ability to hold stakeholders accountable while maintaining positive working relationships.

Additional

Skills & Qualifications

+ Prior project management experience in a manufacturing or regulated environment.

+ Direct and/or indirect…