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.
Be part of Amgen’s newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen’s plan to be a carbon-neutral company by 2027.
**Director, Manufacturing Support**
**What you will do**
Let’s do this. Let’s change the world. In this vital role you will be accountable for lifecycle management, electronic batch records, cleaning & sterilization validation, single use system implementation and support, process ownership, deviation investigations and corrective actions, and technical training for manufacturing.
+ Agile and reliable product lifecycle management
+ New technology implementation and digital advancements
+ Electronic batch record configuration and maintenance
+ Strategy and maintenance of cleaning and sterilization validation programs
+ Single use system design, deployment, and defect support
+ Process ownership inclusive of deviation investigation, CAPA, change control, and project management
+ Finite scheduling of plant operations
+ Technical training for manufacturing staff
The leader will direct staff to ensure plant goals are met and represent the manufacturing organization on projects, site and network teams. The leader is expected to:
+ Anticipate and adapt to environmental factors
+ Champion innovation and continuous improvement
+ Create compelling strategies the help deliver the company’s aspiration
+ Recruit, retain and develop high-performing and diverse teams
+ Set challenging performance expectations and provides timely feedback
+ Build empowered teams that put patients and Amgen first
+ Establish sound plans the enable Amgen’s operational and strategic imperatives
+ Execute with a sense of purpose and drives course correction where appropriate
+ Deliver strong results consistent with compliance requirements and Amgen values.
Specifically, the responsibilities for this position are:
+ Collaborate with cross-functional teams to complete production enabling activities
+ Drive continuous improvement initiatives, programs and projects
+ Deploy new manufacturing technologies to advance manufacturing strategy
+ Ensure that the requirements of the Quality Management System are fulfilled
+ Alert senior management of significant quality, compliance, supply and safety risks
+ Provide input for management reviews
+ Forecast and adhere to a budget for assigned areas
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek is a leader with these qualifications.
**Basic Qualifications:**
+ Bachelor’s degree and 10 years of manufacturing experience OR
+ Master’s degree and 8 years of manufacturing experience OR
+ Doctorate degree and 4 years of manufacturing experience
And
In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
**Preferred Qualifications:**
+ Currently in a leadership position in a GMP manufacturing plant
+ Experience in drug substance manufacturing operations for commercially licensed products
+ Experience with the process validation lifecycle inclusive of process design, process performance qualification, and continued process verification
+ 6 years managing a team, leading and managing operations
+ 2 years experience in applying operational excellence and lean manufacturing principles to drug substance manufacturing
+ Excellent communication and negotiation skills including executive level communication
+ Experience in a matrixed, cross-site or global network environments
**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.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
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.
