New Product Introduction Lead

Amgen; Thousand Oaks (CA); On-site; USD 86,000 - 116,000; Full time

Job summary

Amgen is seeking a Senior Associate Manufacturing for the Thousand Oaks DP facility (B20) to lead New Product Introduction efforts. You will coordinate between Manufacturing, Process Development, Supply Chain, QA and Facilities, owning project plans, timelines and documentation to ensure successful launches of clinical and commercial programs.

The role requires strong GMP knowledge, technical writing, and the ability to drive cross-functional teams toward Right-First-Time execution while

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 2 years of biotechnology operations experience OR Associate’s degree and 4 years of biotechnology operations experience OR High school diploma / GED and 6 years of biotechnology operations experience

Responsibilities

• Maintain an organized way of working with NPI support groups to develop, maintain, and implement the NPI project plan(s).
• Resolving issues in a timely manner and elevating cross-functional concerns to management.
• Own Change Controls in TrackWise ensuring records are compliant per GMP procedures.
• Own NPI record documents in CDOCS and lead cross-functional team meetings to execute NPI projects.

Skills

Project Management

Technical Writing

GMP

Problem Solving

Team Player

Education

Master's or higher in Engineering/Biology/Chemistry/Life Sciences

Bachelor's in Engineering/Biology/Chemistry/Life Sciences + biotech ops experience

Tools

Veeva CDOCS

TrackWise

Job description

Career Category Manufacturing Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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.

• Maintain an organized way of 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.
• Able to clearly articulate problem statements verbally and in writing to management, with a quality-first mindset for recommendations for path forward.
• 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is an individual with these qualifications.

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 2 years of biotechnology operations experience OR Associate’s degree and 4 years of biotechnology operations experience OR High school diploma / GED and 6 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

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.

Sponsorship

Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. 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.

Salary Range

86,048.05USD -116,417.95 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen