NPI Manufacturing Specialist — Onsite, GMP-Driven

Actalent; Thousand Oaks (CA); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability coverage

Health Spending Account (HSA)

Paid time off

Job summary

Actalent in Thousand Oaks, CA is seeking a Specialist Manufacturing New Product Introduction to lead NPI in a cGMP facility. You will plan and execute NPI projects, coordinate cross-functional teams, and ensure GMP/regulatory compliance while maintaining quality standards.

The role is on-site with standard business hours and requires strong PM, communication, and problem‑solving skills. Responsibilities include maintaining project plans, driving milestones, managing change controls in Trackwise,

Qualifications

• Experience leading NPI projects in a regulated environment (cGMP).
• Strong cross-functional collaboration and matrixed team leadership.
• Excellent written and verbal communication with attention to detail.
• Quality-first mindset with GMP compliance and change control familiarity.

Responsibilities

• Develop, maintain, and implement comprehensive NPI project plans with scope, schedule, and risk management.
• Lead cross-functional teams to achieve NPI milestones and deliverables.
• Resolve issues promptly and escalate cross-functional concerns when needed.
• Own and manage change controls in Trackwise with Right-First-Time execution.
• Lead cross-functional meetings to ensure NPI projects align with schedule.
• Communicate clearly with peers and leadership through writing and presentations.
• Engage QA and Regulatory to support regulatory submissions during NPI delivery.
• Review manufacturing protocols with Quality Assurance to maintain GMP standards.
• Identify opportunities for improvement and drive consensus for changes.
• Conduct Gemba walks to identify process improvements in NPIs and lifecycle management.
• Monitor and report team and plant metrics to provide visibility into operations.
• Represent the NPI team at plant and network forums as needed.

Skills

Project management

Cross-functional leadership

Communication

Problem solving

Tools

Trackwise

Job description

Actalent in Thousand Oaks, CA is seeking a Specialist Manufacturing New Product Introduction to lead NPI in a cGMP facility. You will plan and execute NPI projects, coordinate cross-functional teams, and ensure GMP/regulatory compliance while maintaining quality standards.

The role is on-site with standard business hours and requires strong PM, communication, and problem‑solving skills. Responsibilities include maintaining project plans, driving milestones, managing change controls in Trackwise,