Senior Manager, Systems Engineering - Combination Product Development at Amgen

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Senior Manager, Systems Engineering - Combination Product Development

What you will do

Lets do this. Lets change the world. In this vital role you will be the Senior Manager, Systems Engineering (SMSE) in the Combination Product Operations organization. The Systems Engineering team guides in the identification, development, commercialization and improvement of drug delivery technologies to provide optimal patient experience in administration of Amgens therapeutic products. As a leader in the organization, the SMSE will ensure the success of multi-functional drug delivery and combination product development efforts through their lifecycle from feasibility through commercial manufacture. The SMSE will work in collaboration with commercial and research colleagues in identification of user needs from market insights. The SMSE will lead a team responsible for the creation and management of system requirements, development of system architecture, and integration of subsystems. This will require ensuring robust system architecture across the interactions, dependencies, and interfaces of subsystems.

The SMSE will lead a team responsible for the integration of the system through clinical and market entry. The successful candidate will have demonstrated strength and success in managing interactions with key collaborators and colleagues from across process development, operations, research and development, and global commercial organizations to ensure accurate capture of the voice of customer and business into user needs.

• Responsible for recruitment, mentoring, supervision, and directed professional development of a team of systems engineers.
• Lead development of robust drug delivery systems and integrated development efforts applying best Systems Engineering principles in combination product development cycles.
• Lead formal and ad-hoc technical and design reviews for the integrated system.
• Spearhead system definition in conformance to global regulatory guidance and best engineering methods including User Needs and System Design Inputs.
• Responsible for DHF development and clarity of structure across platform, combination product, and vendor structures to ensure quality and visibility.
• Owns integration of requirements, risks, and implemented mitigations through downstream design outputs.
• Drives system verification and validation strategies across platform and brand-specific presentations.
• Owns system performance & reliability targets and subsystem allocations.
• Provides authorship and expert technical leadership for regulatory filings.
• Responsible for recruitment, mentoring, supervision, and directed professional development of more junior engineers.

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 an experienced people manager with these qualifications.

• Doctorate degree and 2 years of Systems Engineering experience OR
• Masters degree and 6 years of Systems Engineering experience OR
• Bachelors degree and 8 years of Systems Engineering experience OR
• Associates degree and 10 years of Systems Engineering experience OR
• High school diploma / GED and 12 years of Systems Engineering experience

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

• Masters Degree or PhD in Engineering in mechanical, systems, materials, electrical, or biomedical engineering.
• 10+ years of demonstrated success in medical device, drug delivery, or combination product development for clinical and commercial entry.
• 5+ years of demonstrated success leading development of system architecture and design for medical device, drug delivery, or combination products from concept through market entry.
• Familiar with the following standards: US Good Manufacturing Practices (21 CFR Part 4, 21 CFR 210/211, 21 CFR 820); Needle-based Injection Systems (ISO 11608-1); Quality Management (ISO 13485); Risk Management (ISO 14971); EU Medical Device requirements (EU MDR 2021); Medical Electrical Equipment (EN 60601).
• Demonstrated product design and development success through product launch in major global regulatory regions.
• Successful experience managing multiple projects in a deadline driven environment.
• Demonstrated strength in controlled development of user needs, market and system requirements, system and process verification and validation strategies, DOE / SPC / Risk Management methods.
• Proficiency driving CTQ hierarchical decomposition (flow-down) to subsystems and components.
• Strong technical communications, both written and oral at different levels of the business.
• INCOSE certification or formal Systems Engineering training/certification.
• Strong understanding of injection molding, electronics fabrication, system assembly and manufacturing processes.
• Working knowledge of aseptic fill finish and controlled manufacturing environments.
• Demonstrated success in platform product development with global multi-generation technology plans.
• Robust knowledge of Quality Management Policies and Systems, practical experience in configuration management and change control process/requirements CCB (change control board), CIT (change implementation team) concepts.
• Proficient with Production Part Approval Process (PPAP) methodology, documenting requirements and providing traceability documentation for FDA Approval - DOORS, Requisite Pro, or other similar requirements management software.
• Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives.

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.

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.

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

for a career that defies imagination

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

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.