About this role

Job Details

Posted 15 October, 2026

Job Id: 631702

Specialist Manufacturing, New Product Introduction

Location

Thousand Oaks, CA

Category: Manufacturing

Salary

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Country: United States

Employment: Contract

Worksite: On-Site

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Job Description

Target PR Range: 25-35/hr DOE

Role: Specialist Manufacturing, New Product Introduction

Candidates will need to demonstrate knowledge of DP technical process, 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 effective communication, both within and outside of the immediate team.

The NPI Lead will be primarily responsible for:

Working with NPI support groups to develop, maintain, and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to meet NPI project milestones.
Resolving issues in a timely manner and elevating cross-functional customer concern to various levels of management as appropriate.
Owning Change Controls in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur through a Right-First-Time approach.
Proactively leading cross-functional team meetings, to ensure NPI project(s) and other relevant business cases execute per schedule.
Succinctly communicating verbally, in writing, and through presentations to peers and senior leadership team.

Additional Responsibilities include:

Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network and with various agency submissions while delivering NPI project(s).
Holding supporting functions accountable for delivery of NPI project tasks through documentation of Lessons Learned and presentation to management when appropriate.
Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch record documentation, and licenses.
Identifying improvement opportunities within the organization and taking proactive steps to build consensus to implement those opportunities.
Performing purposeful presence Gemba walks in the manufacturing plant to identify process improvement opportunities as pertaining to NPIs and relevant lifecycle management strategies.
Reporting on team and plant metrics to ensure visibility to team operations and deliverables.
Representing the team at plant-wide and network-wide forums, as needed.

Preferred Qualifications:

Project Management experience
Direct and/or indirect people management / leadership experience
Understanding of Drug Product Formulation and Vial/Syringe Filling operations
Experience with various quality systems including change control, deviations, corrective and preventative actions, and/or validation practices
Strong organization and technical writing skills; able to articulate complex problems concisely with technical and management staff
Independent, self-motivated, able to multi-task in a fast-paced environment
Team-player
Demonstrated flexibility and ability to manage change
Direct experience with regulated environments (e.g., cGMP etc.)

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us(opens in new tab) directly so that we can explore the appropriate arrangements.

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