New Product Introduction Lead - Thousand Oaks CA

Job Description

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Senior Associate Manufacturing - Building 20 Drug Product Manufacturing New Product Introduction (NPI)

What you will do

Let's do this. Let's change the world. In this critical role for the Thousand Oaks Drug Product (DP) facility - also known as ATO B20 - you will be responsible for the introduction of new products into the manufacturing plant. ATO B20 serves as a key launch point for Amgen's new programs progressing through clinical development, and the Sr Associate Manufacturing role directly enables the production of these programs in the ATO facility. This Senior Associate Manufacturing role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital team at ATO B20, reporting into the Manager Manufacturing Programs.

The NPI Lead is expected to have ownership over the Technology Transfer Project Planning, an activity that is vital to the impact that ATO B20 has with a clinical and commercial product mix to the Amgen network. This role will function as the site interface between the Amgen network, e.g. Operations Strategy & Business Resilience, Product Delivery Teams, and the B20 site consisting of 5 key functions: Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering. A high degree of interactions and collaboration is required across these groups, and the NPI Lead needs to be able to 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 manufacturing 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.

Senior Associate Manufacturing for the New Product Introduction team will be primarily responsible for:

Working with NPI support groups (e.g. PD, Manufacturing, F&E, QA) 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 (i.e. drive Root Cause Analyses) 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.

Owning NPI record documents in CDOCS (Veeva system)

Proactively leading cross-functional team meetings, to ensure NPI project(s) execute per schedule

Additional Responsibilities include:

Holding supporting functions accountable for delivery of NPI project tasks through documentation of Lessons Learned and presentation to management when appropriate.

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.

Additional Qualifications/Responsibilities

Basic Qualifications:

Master's degree in Engineering, Biology, Chemistry or Life Science Field OR

Bachelor's degree in Engineering, Biology, Chemistry or Life Science Field and 6 months of biotechnology operations experience OR

Associate's degree and 2 years of biotechnology operations experience OR

High school diploma / GED and 4 years of biotechnology operations experience

Preferred Qualifications:

Strong organization and technical writing skills; able to articulate complex problems concisely with technical and management staff of varying organizational levels in both presentation and technical writing forms

Project Management Experience

Understanding of/Experience in Drug Product Formulation and Vial/Syringe Filling operations in a GMP environment

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.)

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.


Salary Range
86,048.05USD -116,417.95 USD