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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you are 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.

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.

Director Engineering, Process Development: located at the Amgen Advanced Assembly and Final product Operations New Albany, Ohio

Live

What you will do

Let’s do this. Let’s change the world! In this vital role you will provide managerial and technical leadership to the Process Development (PD) functional unit within Amgen Ohio supporting equipment design, qualification and leading new products technology transfer activities to the site, in partnership with other functions.  Specific responsibilities include but are not limited to:

• Ensure safety, quality, and compliance in our cGMP operations

• Establish and execute sound plans that enable Amgen’s 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 provide 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.

• Lead Product Transfer and Process Validations

• Assist the manufacturing plant during FDA and other y inspections/audits, providing technical support and / or assessments in response to the FDA and other regulatory agencies

• Lead Technical investigations, ensuring consistency and compliance with external regulatory requirements

• Prepare and maintain department budget and workforce model

• Champion innovation and continuous improvement

• Support the Manufacturing Operational excellence program and its execution

• Anticipate and adapt to environmental factors and analyses and forecasts business trends

• Build compelling strategies that help deliver the company’s 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 Process Development team 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

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Director Process Development professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 4 years of combined Process Development, Quality and/or direct Manufacturing experience within the pharmaceutical, combination product, medical device and/or biotechnology industry.
Or

Master’s degree and 8 years of combined Process Development, Quality and/or direct Manufacturing experience within the pharmaceutical, combination product, medical device and/or biotechnology industry.
Or
Bachelor’s degree and 10 years of combined Process Development, Quality and/or direct Manufacturing experience within the pharmaceutical, combination product, medical device and/or biotechnology industry.

AND

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

Beyond that, additional preferred qualifications are:

• Life Science and/or Engineering educational background.

• Experience managing a technical group in regulated environments (i.e. cGMP, OSHA, EPA).

• Excellent verbal and written communication skills.

• Good organizational and communications skills.

• Knowledge of staff relations with the ability to coach, mentor and counsel staff

• Knowledge of basic compensation system practices and methodologies.

• Negotiating, Budgeting, Goal setting and Capacity Planning/Inventory skills.

• Leadership and teambuilding skills with the ability to deal with and manage changes

• Computer Knowledge (MS Word, Excel, PowerPoint, Maximo)

• Knowledge in lean six sigma with a continuous improvement mindset. Ability to resolve conflicts, make disciplined decisions and handle multiple projects at one time.

• Ability to prioritize efforts and delegate resources with a Multi-task project expertise

Thrive

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.

careers.amgen.com