New Product Introduction Lead

Amgen • Thousand Oaks, CA

1d • Onsite

About The Position

Join Amgen’s Mission of Serving Patients. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. 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.

Requirements

• 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

Nice To Haves

• 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.)

Responsibilities

• 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
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level