Director Manufacturing, Advanced Assembly & Final Product Operations

New Albany, OH
Oct 13, 2021
Required Education
Bachelors Degree
Position Type
Full time

Director Manufacturing, Advanced Assembly & Final Product Operations

New Albany, Ohio


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, Ohio


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 experience


Masters degree and 8 years of Manufacturing/Operations experience


Bachelors degree and 10 years of Manufacturing/Operations experience


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.)

  • Financial acumen

  • 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

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.

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.

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.