Director Manufacturing, Advanced Assembly & Final Product Operations
Director Manufacturing, Advanced Assembly & Final Product Operations
New Albany, Ohio
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you are 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. Join us.
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 Amgens 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 Amgens plan to be a carbon-neutral company by 2027.
Director of Manufacturing: Amgen Advanced Assembly and Final product Operations
New Albany, OhioLive
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 directly to the Executive Director Plant Manager and have responsibility for leading the manufacturing function of assembly and packaging:
Ensure safety, quality, and compliance in our cGMP operations
Establish and execute sound plans that enable Amgens operational and strategic imperatives
Lead and coordinate resources to ensure product quality standards and supply plans are met within planned budget
Contribute to the business results through quality of decisions, results and advice
Set exciting performance expectations and provides timely feedback
Develop and implement metrics to track and lead successful, timely accomplishment of assigned goals, objectives and projects
Deliver strong results consistent with compliance requirements and Amgen values
Support the startup and validation of new systems and/or equipment automation systems to ensure requirements/specifications per Amgen standards.
Assist the manufacturing plant during FDA and other regulatory agency inspections. providing technical support and or assessments in response to the FDA and other regulatory agencies
Responsible for conducting all production related investigations, ensuring consistency and compliance with external regulatory requirements
Prepare and maintain department budget and workforce model
Champion innovation and continuous improvement
Lead the Manufacturing Operational excellence program and its execution
Execute with a desire and purpose and drives course correction where appropriate
Anticipate and adapt to environmental factors and analyses and forecasts business trends
Build compelling strategies that help deliver the companys aspiration
Plan and execute the implementation of major change efforts
Recruit, retain and develop high-performing and diverse teams
Build empowered teams that put patients and Amgen first
Serve as a role model and coaches and develops direct reports towards their fullest potential.
Provide organizational leadership of the manufacturing operations team. Lead all aspects of talent management, including performance, career development, and succession planning
Develop short/long term strategies, goals, objectives, and associated budgets required to ensure appropriate manufacturing operations and site deliverables
Foster and maintain relationships with key site and network stakeholders
What we expect of you
Doctorate degree and 4 years of Manufacturing/Operations experienceOr
Masters degree and 8 years of Manufacturing/Operations experienceOr
Bachelors degree and 10 years of Manufacturing/Operations experienceAnd
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, and programs or directing the allocation of resources.
We are all different, yet we all use our unique contributions to serve patients. The Manufacturing professional we seek is a strong leader with these qualifications:
Experience in a technical manufacturing operations leadership field, preferably in the Pharmaceutical and/or Biotech industry
Diverse, hands-on operations experience in the manufacture of biologics with aseptic processing, drug substance and drug products focus
Proven managerial experience and track record of compliance in a highly regulated GMP environment
Strong leadership experience and aptitude with proven ability to effectively lead and partner in a complex, matrix environment
Cross-functional work experience in either Process Development, Quality or Engineering
Excellent communication skills, drive, purpose, energy level and problem-solving
Demonstrated ability to develop and maintain positive relationships with other functional areas
Ability to effectively develop and mentor staff and positively advance the culture of an organization
Operational Excellence mentality with diverse, and profound Continuous Improvement methodology experience (e.g., Lean, Six Sigma, Total Quality Management (TQM), etc.)
Communications skills, both oral and written, including executive presentation skills
Interpersonal and facilitation skills necessary to forge consensus among challenging client interests while ensuring objectives are met
Ability to tactfully negotiate and positively influence peers and executive leadership
Knowledge of industry trends (e.g., regulatory and compliance, technology, human performance programs, sustainability, etc.)
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
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Join UsIf 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.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.