Amgen Sr Manager, Final Product Platform Technical Lead in Thousand Oaks, California
An exciting organizational and technical leadership opportunity to be a major contributor in a high functioning worldwide Final Product Technologies (FPT) organization. As the Amgen commercial landscape continues to exponentially grow, the CORE group, as part of FPT, expands to continuously develop, enable, and manage the current and future opportunities in field of platform delivery systems and technologies.
The Sr. Engineering Manager, Platform Technical Lead (PTL) will be part of the platform leadership team. This team is accountable for lifecycle management of Prefilled Syringe and Lyo Kit systems as crucial part of the Amgen combination product portfolio. The team also provides technical representation across multiple globally commercialized drug product teams.
The Sr. Engineering Manager will manage team of device engineers that are responsible to assess, develop, and implement combination product related changes and manage technical documentation to ensure compliance through lifecycle of commercialized products. This also includes development and implementation of innovative solutions to enhance user experiences, as well as enabling new product global launches and variation management.
The position is located in Thousand Oaks, CA or Cambridge, MA
· Develop device engineering prioritized project plans and manage global implementation strategies by working with product teams, program budgets, manufacturing network interactions, business and safety risks, and timelines for each project.
· Develop business strategies related to supply continuity, variation management, product defense, and growth.
· Manage deliverables from multiple cross functional project teams of internal and external personnel to ensure resources are available to analyze/resolve product issues and drive system level integration readiness.
· Engage in internal and external global network organizations and associated initiatives. Provide organizational and team guidance for strategic business and compliance initiatives.
· Develop a high performing team and individual staff by developing, mentoring, and coaching.
· Maintain compliance of technical design records within design history file and defending them during audits and inspections.
· Conduct work utilizing Engineering judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devise new approaches to problems encountered.
· Work in close coordination with teams to define the approach, identifying and planning with the design team for implementation of engineering updates, based on complaints, CAPA's or improvement in usability, scale-ups, and strategic imperatives.
· Utilizes the following standards and regulations:
o Quality System Regulation – 21CFR820
o Risk Management – ISO 14971
o EU Medical Device requirements – Council Directive 93/42/EEC
· 10% Domestic and International travel.
Doctorate degree and 2 years of Engineering or lifecycle management in delivery systems
Master’s degree and 6 years of Engineering or lifecycle management in delivery systems
Bachelor’s degree and 8 years of Engineering or lifecycle management in delivery systems
Associate’s degree and 10 years of Engineering or lifecycle management in delivery systems
High school diploma / GED and 12 years of Engineering of lifecycle management in delivery systems
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Mechanical, Materials Science, Chemical, or equivalent engineering degree
10+ years of Biotech and medical device industry experience and regulated work environment experience
A background in developing and commercialization of medical devices and knowledge of manufacturing processes.
Strong understanding and experience in design controls, failure investigation, initiating and bringing complex projects to conclusion and the ability to work independently and dynamic cross functional teams
Excellent written and verbal communication skills
Strong team-oriented skills, self-driven with ability to drive projects requiring cross-functional collaboration
Analytical skills to interpret data and use independent judgment and discretion in developing solutions to a variety of work problems of moderate scope and complexity
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 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.
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.