NPI Manufacturing Specialist - Onsite 12-Month Contract

AGW; Thousand Oaks (CA); On-site; USD 32,000 - 52,000; Full time

Job summary

AGW is seeking a Specialist Manufacturing, New Product Introduction for an onsite role in Thousand Oaks, CA. You will lead the introduction of new products into the DP manufacturing plant, coordinating Manufacturing, Process Development, Quality, Regulatory and Supply Chain to meet milestones.

The role requires strong project management, GMP knowledge, and ability to influence teams; duties include Change Controls in Trackwise, Gemba walks, and reporting metrics.

Qualifications

• NPI experience in drug product manufacturing
• Strong project management and cross-functional leadership
• Familiarity with GMP and regulatory expectations

Responsibilities

• Develop, maintain, and implement the NPI project plan with defined scope and milestones
• Lead cross-functional teams to meet project milestones via influence
• Own Change Controls in Trackwise and ensure GMP compliance
• Lead cross-functional meetings to ensure execution per schedule
• Communicate effectively with peers and senior leadership
• Coordinate with Quality and Regulatory for alignment and submissions
• Review manufacturing protocols with QA to maintain GMP standards
• Identify improvement opportunities and drive consensus
• Perform Gemba walks to identify NPIs improvements
• Report team and plant metrics for visibility
• Represent the team at plant and network forums

Skills

Project management

GMP knowledge

Cross-functional collaboration

Problem solving

Documentation

Education

Doctorate degree

Master's degree + 2 years experience

Bachelor's degree + 4 years experience

Associate degree + 8 years experience

High school diploma / GED + 10 years experience

Tools

Trackwise

Job description

AGW is seeking a Specialist Manufacturing, New Product Introduction for an onsite role in Thousand Oaks, CA. You will lead the introduction of new products into the DP manufacturing plant, coordinating Manufacturing, Process Development, Quality, Regulatory and Supply Chain to meet milestones.

The role requires strong project management, GMP knowledge, and ability to influence teams; duties include Change Controls in Trackwise, Gemba walks, and reporting metrics.