New Product Introduction Lead

Senior Associate Manufacturing - Building 20 Drug Product Manufacturing New Product Introduction (NPI) What You Will Do In this critical role at the Thousand Oaks Drug Product (DP) facility – also known as ATO B20 – you will be responsible for introducing new products into the manufacturing plant. You will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital team at ATO B20, reporting to the Manager Manufacturing Programs. The NPI Lead has ownership over the Technology Transfer Project Planning, serving as the site interface between Amgen’s network and the B20 site functions: Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering. This role demands high interaction and collaboration across teams, requiring a solid understanding of their business and manufacturing processes to drive decision‑making and impose timelines. 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. 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). What You Can Expect Of Us We support 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. 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, 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 including: 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. Amgen is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #J-18808-Ljbffr Amgen