Amgen Sr Manager Manufacturing in Columbus, Ohio
HOW MIGHT YOU DEFY IMAGINATION?
Does the thought of building an entirely new site, from the ground up excite you? Do you love building and developing high performing teams? If you have a passion for talent development and want to be a part of Amgen’s mission to serve patients – every patient every time – then check out this exciting new opportunity.
Be part of the Amgen Advanced Assembly and Final Product Operation, a new facility focused on medical device assembly and packaging of injectable medicines. When completed, the Advanced Assembly and Final Product Operation facility will not only feature the best in-class assembly and packaging 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.
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
Sr Manager Manufacturing Support- Assembly and Packaging
What you will do
Let’s do this. Let’s 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 ANA’s success, it is a key contributor in ANA’s daily operation and is considered part of the Leadership Team.
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 teamsExplain 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 EVsand 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 & hands–on support in complex troubleshooting exercises
Lead in the development of the Process Owner’s 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 team’s 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
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
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
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
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
Doctorate degree and 2 years of manufacturing support experience
Master’s degree and 6 years of manufacturing support experience
Bachelor’s degree and 8 years of manufacturing support experience
Associate’s degree and 10 years of manufacturing support experience
High school diploma / GED and 12 years of manufacturing support experience
2 years of experience managing people and/or leadership experience leading teams, projects, and programs or directing the allocation of resources
Beyond that, additional preferred qualifications are:
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
What you can expect of us
As we work to develop treatments that take care of others, so we 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
On site cafeteria and gym
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.
Amgen requires all staff in the United States and Puerto Rico 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.
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.