Director, Manufacturing Support

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgens 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 Amgens plan to be a carbon-neutral company by 2027.

Director Manufacturing Support

What you will do

Lets do this. Lets change the 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 companys 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 Amgens 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:

• Bachelors degree and 10 years of manufacturing experience OR
• Masters 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 well 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.

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.

Salary Range