The Director leading Amgen's Prefilled Syringe (PFS) and Lyo Kit systems is responsible for representing the Amgen Final Product Platforms in the Final Product Platform Governance ecosystem. This newly established ecosystem is designed to ensure Amgen will have clear final product platforms, accountabilities, and communication across functions in Commercial, Operations, and Regulatory Labeling that are responsible for various aspects of the platform. The PFS Platform lead will be accountable for ensuring decision making and adherence to defined final product platforms, ensure product changes are applied consistently and optimally within the PFS platform and across platforms as appropriate.
- Provide leadership, oversight, and overall representation to Amgen's PFS and Lyo Kit Final Product platform
- Responsible for platform process being followed, milestones achieved, and risks mitigated
- Manage governance body involvement and endorsement
- Provide PFS & Lyo Kit Platform subject matter expertise in Fit to Platform Assessments, Product Technical Review, and Lifecycle management product strategies
- Identify product issues/opportunities for 'in scope' device platforms and drive business case for cross product implementation (within Operations, R&D, and global Commercial)
- Determine platform boundaries across operations, commercial, and labeling regulatory
- Provide engineering team-appropriate prioritizing of programs, including product lifecycle management and compliance related activities
- Direct management of engineering team responsible for technical execution and life cycle management activities
Estimated travel is 10-20%
This role requires the coordination and development of transparent, objective, and informed planning across the Global and US organizations to leverage the Final product platform ecosystem. Supervisor responsibility as functional org-leader managing professional engineering team. In order 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. At the core of any successful leader is a high-performing matrixed team built upon trust, mutual respect, diversity, and the unrelenting desire for continuous improvement. In this regard, the PFS platform Director will need to actively mentor, develop, and retain top talent across the entire ecosystem. The PFS Director is expected to successfully coach the team to employ best practices, challenge the status quo, and streamline processes where possible to drive efficiency. Additionally, the individual must be able to leverage market/supplier knowledge and business to interrogate assumptions and understand the real drivers behind deviation from a Platform. Finally, the ability to foster an environment of cooperation with Finance, Marketing, Manufacturing, and Product teams is critical. This position reports to the Executive Director of CORE Engineering.
This position will have the following authority:
- Decision rights on Final Product Platform content for components, platform boundaries, and brand-specific minimum requirements
- Accountable for managing boundary conditions for each platform components across Amgen (globally)
- Decision rights on escalating decision and issues to appropriate Governing body
- Functional budget responsibility, as applicable
- Functional Org-leadership accountability
Doctorate degree & 4 years of Engineering, Physical Sciences or related areas experience
OR Master's degree & 6 years of Engineering Physical Sciences or related areas experience,
OR Bachelor's degree & 8 years of Engineering, Physical Sciences or related areas experience
M.S. or Ph. D. in Engineering, Physical Sciences or related areas experience with 5+ years of experience in the Medical Device industry and Pharmaceutical Industry
- Leadership experience in building and developing high performing teams, delivering results and shaping the future
- Allocate resources, prioritize activities and manage multiple stakeholders 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 adherence
- 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 and In-direct staff management experience; including performance management, hiring and onboarding, and staff development
- Direct experience with Prefilled syringe systems in Biotechnology
- Extensive combination product experience (international)
- 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
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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, or disability status.