Amgen

Career Category

Operations

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. 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.

Sr Manager Engineering - Pre-Filled Syringe Platform

What you will do

Let’s do this! Let’s change the world!

We are currently seeking a Senior Manager of Engineering – Platform Technical Lead for our Pre-Filled Syringe (PFS) Platform. As part of the Combination Product Development (CPD) group, this role will support technical teams in the successful design, testing, manufacturing and commercial sustainment of pre-filled syringe drug delivery devices for Amgen combination products. The Senior Manager of Engineering will collaborate with global team members across systems engineering, process engineering, device development, packaging, primary containers, device quality, product delivery teams, and other groups.

In this role, the Senior Manager will lead the testing, design transfer, post-market surveillance, and life cycle management of multiple pre-filled device commercialization efforts. This includes overseeing engineering, characterization, and GMP verification testing, while ensuring alignment with project goals and timelines. The position requires close collaboration with suppliers to enable capacity expansions and evaluate new design changes and improvements, and it demands strong technical background in mechanical engineering and functional leadership of technical teams focused on device design, testing, manufacturing, and regulatory compliance.

The role also requires ensuring compliance with regulatory requirements and quality standards for combination product technologies, while driving the continuous improvement of processes, methods, and tools used in the development and life cycle management of pre-filled syringe devices. The Senior Manager will oversee the creation of technical documentation, including test plans, protocols, reports, and regulatory submissions, and ensure alignment of project timelines, resource allocation, and risk management for successful device commercialization. They will also monitor and assess the lifecycle of pre-filled syringe devices to ensure post-market performance and regulatory compliance.

Furthermore, the Senior Manager will play a key role in supplier management, ensuring that quality and technical specifications are met at all stages of product development and supply. They will provide support to the manufacturing network by ensuring efficient production processes and resolving any technical issues that arise during manufacturing. In addition, they will support agency inspections and respond to Regulatory Technical Queries (RTQs), collaborating with regulatory and product teams to ensure timely and accurate responses to inspection findings or queries.

This role requires strong proficiency in technical team management, mechanical design, drug combination product technologies, and regulatory requirements. The successful candidate will be expected to collaborate with vendors and Amgen suppliers to facilitate the accurate planning and execution of design activities.

To be successful in this role the individual must be able to not only manage the operations process, but must also be skilled at influencing, networking, and navigating a complex internal set of teams and functional groups external to operations. The Senior Manager will need to actively develop and retain top talent across the entire ecosystem. The Senior Manager is also expected to successfully coach the team to employ standard processes, challenge the status quo, and streamline processes where possible to drive efficiency. Additionally, the individual must be able to use market/supplier knowledge and business to interrogate assumptions and understand the real drivers behind deviation from a Platform.

Finally, the ability to cultivate an environment of collaboration with (External) Supply Chain, Marketing, Manufacturing, and Product teams is critical.

Responsibilities include:

• Provide leadership, oversight, and overall representation to Amgen’s Pre-Filled Syringe Combination Product platform
• Proficiency in Fit to Platform Assessments, Product Technical Review, and Lifecycle management product strategies
• Identify product issues/opportunities for ‘in scope’ device platforms and drive solutions for cross product implementation (within CPO, Product delivery and Supply Chain organizations)
• Consider platform boundaries across operations, commercial, and regulatory labeling
• Support appropriate prioritizing of programs, including product lifecycle management and compliance related activities
• Direct management of professional engineering team responsible for technical assignments and life cycle management activities
• Estimated travel is 10-20%

This position will have the following authority:

• Decision rights on combination product lifecycle management for components, platform boundaries, and brand-specific minimum requirements
• Accountable for managing design engineers maintaining the existing platforms pre-filled syringes and ensuring proper transfers to new plants
• Responsible for raising decisions and issues to appropriate governing bodies
• Direct interaction with suppliers and multi-functional teams within Amgen to ensure continuous supply of products

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

• High school diploma / GED and 12 years of Operations experience OR
• Associate’s degree and 10 years of Operations experience OR
• Bachelor’s degree and 8 years of Operations experience OR
• Master’s degree and 6 years of Operations experience OR
• Doctorate degree and 2 years of Operations experience
• In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications:

• M.S. in Mechanical Engineering, Material Sciences or related areas experience with 4+ years of experience in the Medical Device industry and Pharmaceutical Industry
• Combination product experience (Drug Product and/or Medical Devices)
• Leadership experience in building and developing successful teams, delivering results, and shaping the future
• Strong problem-solving skills with the ability to be a clear thinker, work through complex problems, and determine an end solution
• Allocate resources, prioritize activities, and manage multiple partners to support leaders across the business including working with leaders across functions
• Business acumen that lends itself to understanding the context and dynamics of pharmaceutical challenges that impact Platform alignment
• Partners with business leaders to deliver high-quality outcomes using strategic decision making (DAI)
• Thinks strategically about issues impacting an entire portfolio of therapeutics versus Platform adherence
• Direct or In-direct staff management experience; including performance management, hiring and onboarding, and staff development
• Excellent written and verbal communication skills together with demonstrated ability to work in a team environment
• Experience with the fill finish manufacturing process (glass/elastomers/polymers), device assembly and packaging for medical (aseptic) applications
• A passion to deliver excellent work product, develop others with an infective positive attitude
• Ability to travel +/- 20% of time
• 2+ years of managerial experience directly leading people or experience leading teams, projects, programs and directing allocation of resources.

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, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

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Salary Range

154,852.00 USD - 186,251.00 USD

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