Senior Manager, Manufacturing

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.

Sr Manager Manufacturing Support- Assembly and Packaging

Live

What you will do

Lets do this. Lets change the world. At Amgen, we are committed to being science-based and follow a continuous learning approach to advancing science, driving discovery and igniting innovation that works to help reduce disease. It is in this context that we endorse an inclusive and diverse workforce that helps fuel scientific innovation and problem solving, leading to better scientific solutions that benefit both patients and society.

In this vital role you will be responsible for leading and managing the process owners at the ANA Assemble and Packaging Plant. The process owners are responsible for documentation (SOP, PTC, FORM, Manufacturing Procedure), QMS records (Deviation, CAPA, Change Control, CAPA EV), Electronic Batch Records and Risk Assessments. Reporting to the Executive Director Plant Manager, this role will support the other functional areas Assembly and Packaging (Vials, Syringes, Devices), Engineering, Process Development, Quality, Validations, IS, Regulatory and other functions as required. This role is crucial for ANAs success, it is a key contributor in ANAs daily operation and is considered part of the Leadership Team.

Technical

• Manage the manufacturing Process Owner team that provides technical, project, emergency response, and troubleshooting support to the manufacturing areas.
• Lead the relevant process owner team to achieve plant goals and objectives
• Ensure consistent global operational practices are implemented through alignment with standards and continued evaluation of practices by engaging in relevant global networks and teams. Explain Assembly and Packaging process to other plant support teams (Manufacturing, QA, F&E, PD, Logistics, HR, etc.)
• Ensure process owner has the ability to own Deviations, Change Controls, CAPAs, CAPA EVs and CDOCS documents (Quality System records & documents)
• Oversee the development, revision, review, and approval of all documents (SOPs, FORMS, Deviations, CAPAs, CC, etc.) that are owned by the process owners
• Support the plant in the project approval, prioritization and implementation process
• Develop functional area metrics to support the benchmarking of site, global, and industry. Develop improvement strategies based off the benchmarking data.
• Provide technical direction to the team
• Provide on-the-floor & handson support in complex troubleshooting exercises

Planning

• Lead in the development of the Process Owners long and short-term strategies, goals and objectives that ensure the department and plant achieves the company goals
• Ensure the coordination and goal alignment of functional area and plant production operations
• Participate in Plant Level Work Center Team (WCT) Meeting and Lead Process Owners daily WCT
• Develop plans and ensure adequate staffing and knowledge to ensure Target Dates for the teams work (NPI, CAPA, Change Control, SOP and EBR revision, risk assessments, etc.) are met
• Develop, control, maintain, track, justify and stay within the functional area budget

Support Functions

• Collaborate with and serve as department liaison to support other organizations (Manufacturing, QA, F&E, PD, IS, etc.)
• Resolve issues between manufacturing, quality and maintenance organizations

Compliance

• Ensure Assembly and Packaging practices (processes & methods) and policies align with external regulatory requirements and internal corporate and site guidelines and procedures
• Connect with Regulatory Compliance and Quality Assurance to ensure the functional area stays in compliance
• Develop, approve, establish and ensure practices and policies are consistent
• Main Manufacturing point of contact in regulatory audits
• Assure the appropriate level of training is available and assigned for staff at all levels of the relevant functional area

Staff

• Coach, mentor and ensure the development of supervisors and staff
• Partner with HR to recruit, retain and empower staff
• Ensure an ongoing organizational structure capable of adapting to changing business needs
• Ensure safety goals are communicated and supported in alignment with ongoing plant safety programs
• Ensure functional area staff exemplifies the Amgen Values & Behaviors
• Ensure an executable Succession Plan is in place for the relevant functional area

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Sr Manager Manufacturing Support professional we seek is a leader with these qualifications

Basic Qualifications:

Doctorate degree and 2 years of manufacturing support experience

or

Masters degree and 6 years of manufacturing support experience

or

Bachelors degree and 8 years of manufacturing support experience

or

Associates degree and 10 years of manufacturing support experience

or

High school diploma / GED and 12 years of manufacturing support experience

and

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

Preferred Qualifications:

• Educational background in Life Sciences or Engineering
• Availability to support the manufacturing operation on Non Standard Shifts, Nights or Weekends (On call and/or on site) as needed
• Experience with Drug Product manufacturing technologies / equipment, specifically Assembly and Packaging manual and automated equipment
• Regulatory knowledge and interactions
• Knowledge of conflict resolution and negotiating skills
• Ability to partner with other departments / functions / areas
• Analytical problem solving
• Considerable organizational skills
• Technical writing and presentation skills.
• Basic project management skills.
• Knowledge of control charting and statistics
• Experience in coaching, mentoring and counseling
• Ability to deal with and manage fast and constant change
• Ability to set goals
• Ability / experience in working in fast paced manufacturing environment where issues must be assessed, understood and resolved immediately
• Customer satisfaction mentality
• Ample knowledge of cGMP Regulations around Sterile Product Manufacturing, Combination Products and other relevant area regulatory requirements
• Ability to maintain an environment and culture of operational excellence and continuous improvement
• Proven experience implementing a continuous improvement program based on performance monitoring through KPIs
• Desire to create an environment with Diversity, Inclusion and Belonging

Thrive

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.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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Join Us

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.

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.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.