Senior Manager Engineering- Auto Injector Device Platform

　　Live

　　What you will do

　　Let’s do this. Let’s change the world. In this vital role you will manage a diverse team responsible for identification, development, commercialization, and continuous improvement of drug delivery technologies to optimize the patient experience for Amgen’s portfolio of therapeutic products.

　　We are currently seeking a Senior Manager of Engineering for the ANNIE Platform. As part of the Combination Product Development (CPD) group, this senior manager role will support technical teams in the successful design, testing and commercial development of the ANNIE autoinjector drug delivery devices. The Senior Manager of Engineering will interact with global team members from systems engineering, process engineering, device development, packaging, primary containers, device quality, and other groups.

　　Responsibilities of this position include leading an Engineering team in support of design, testing, transfer, and life cycle management of multiple auto injector device commercialization efforts. Testing activities will include engineering, characterization, and GMP verification as well as interacting with suppliers in the evaluation of new design changes. The position requires a strong proficiency in technical team management, drug combination product technologies and regulatory requirements. This role will also collaborate with vendors and Amgen suppliers to facilitate the accurate planning and carrying out of design activities including CAD design of test tools and fixtures, testing, and method development.

　　Responsibilities include:

　　Provide leadership, oversight, and overall representation to the ANNIE 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 and Supply Chain organizations)

　　Consider platform boundaries across operations, commercial, and labeling regulatory

　　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

　　Coordinates with design team to inform device platform characterization testing and documentation strategies

　　Identifies synergies across combo product SKU development programs and helps drive alignment/consistency among program leads

　　Integrates CPO, quality, and regulatory requirements to define and drive SKU/platform testing efficiency gains

　　Collaborates with functional management to determine appropriate scope and resource allocation for SKU team support

　　Reinforces best practices (design control elements, DAI process, robust investigations) during SKU development to ensure high-quality decision-making among program leads

　　Advises and supports various platform documentation initiatives in collaboration with Systems Engineering

　　Oversees platform readiness for commercial complaints in collaboration with program leads, complaints management, and risk management

　　Supports regulatory authoring, DV, review, and process improvements as needed

　　Estimated travel is 5-10%

　　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 of ANNIE and ensuring proper transfer to new facilities

　　Responsible for raising decisions and issues to the appropriate Governing body

　　Direct interaction with suppliers and cross-functional teams within Amgen to ensure continuous supply of products

　　Functional leadership accountability

　　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 Finance, Marketing, Manufacturing, and Product teams is critical.

　　Win

　　What we expect of you

　　Basic Qualifications:

　　Doctorate Degree and 2 years of Engineering or Medical Device experience

　　OR

　　Master's Degree and 6 years of Engineering or Medical Device experience

　　OR

　　Bachelor's Degree and 8 years of Engineering or Medical Device experience

　　OR

　　Associates degree and 10 years of Engineering or Medical Device experience

　　OR

　　High School Diploma / GED and 12 years of Engineering or Medical Device experience

　　And

　　2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

　　Preferred Qualifications:

　　M.S. in Engineering, Physical Sciences or related areas experience with 5+ 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

　　Thrive

　　What you can expect of us

　　As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

　　Amgen offers a Total Rewards Plan comprising 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:

　　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 and bi-annual company-wide shutdowns

　　Flexible work models, including remote work arrangements, where possible

　　Apply now

　　for a career that defies imagination

　　Objects in your future are closer than they appear. Join us.

　　careers.amgen.com

　　Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

　　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.