NPI Manufacturing Specialist

Position:
Specialist Manufacturing, New Product Introduction
Duration: 6 + Months

Location:

Thousand Oaks, CA (ATO B20) - onsite Job Description

We are seeking a Specialist Manufacturing to serve as a New Product Introduction (NPI) Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital team at a Drug Product (DP) manufacturing facility.

The NPI Lead will own Technology Transfer Project Planning, an activity vital to the site's ability to support a clinical and commercial product mix across the broader manufacturing network. This role functions as the site interface between the network (e.g., Operations Strategy & Business Resilience, Product Delivery Teams) and site functions including Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering.

A high degree of interaction and collaboration is required across these groups, and the NPI Lead must understand their business and manufacturing processes with enough confidence to drive decision-making and impose timelines. Candidates will need to demonstrate knowledge of DP technical processes, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative/analytical troubleshooting skills. The NPI Lead will be responsible for leading cross-functional projects to deliver NPIs on time through effective indirect people management and communication, both within and outside of the immediate team.

• Work with NPI support groups to develop, maintain, and implement the NPI project plan(s), owning scope, schedule, and risk management, and leading matrixed teams through influence to meet project milestones.
• Lead cross-functional business cases to ensure the plant operates according to its long-term strategy through a sustainable pace of new commercial product introductions.
• Resolve issues in a timely manner and elevate cross-functional concerns to various levels of management as appropriate.
• Own Change Controls within the site's electronic quality management system, ensuring records are comprehensive and compliant per GMP regulatory procedures, using a Right-First-Time approach.
• Proactively lead cross-functional team meetings to ensure NPI project(s) and other relevant business cases execute per schedule.
• Succinctly communicate verbally, in writing, and through presentations to peers and senior leadership.
• Engage with Quality and Regulatory teams to ensure alignment and compliance across the network and with agency submissions while delivering NPI project(s).
• Hold supporting functions accountable for delivery of NPI project tasks through documentation of lessons learned and presentation to management when appropriate.
• Review protocols for manufacturing activities and partner with Quality Assurance to ensure GMP standards are maintained in line with current SOPs, batch record documentation, and licenses.
• Identify improvement opportunities within the organization and take proactive steps to build consensus to implement them.
• Perform purposeful presence (Gemba) walks in the manufacturing plant to identify process improvement opportunities related to NPIs and lifecycle management strategies.
• Report on team and plant metrics to ensure visibility into team operations and deliverables.
• Represent the team at plant-wide and network-wide forums, as needed.

• Doctorate degree; OR
• Master's degree in Engineering, Biology, Chemistry, or a Life Science field with 2+ years of directly related GMP manufacturing experience; OR
• Bachelor's degree in Engineering, Biology, Chemistry, or a Life Science field with 4+ years of directly related GMP manufacturing experience; OR
• Associate's degree with 8+ years of directly related GMP manufacturing experience; OR
• High school diploma/GED with 10+ years of directly related GMP manufacturing experience.

• Project management experience.
• Direct and/or indirect people management/leadership experience.
• Understanding of Drug Product formulation and vial/syringe filling operations.
• Experience with quality systems including change control, deviations, corrective and preventive actions, and/or validation practices.
• Strong organizational and technical writing skills; able to articulate complex problems concisely to technical and management staff.
• Independent, self-motivated, and able to multi-task in a fast-paced environment.
• Team player with demonstrated flexibility and ability to manage change.
• Direct experience in regulated environments (e.g., cGMP).

Additional Information

All your information will be kept confidential according to EEO guidelines.