Sr Manager Engineering- Process Development

hem, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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What you will do

Let's do this. Let's change the world. In this role the Senior Manager Engineering will support the development and implementation of technical solutions for a variety of engineering initiatives supporting the FDP product portfolio at the Amgen Ohio manufacturing site. The position is a key role in the Process Development group and the candidate must manage and/or apply extensive technical expertise in the coordination of multiple, sophisticated, non-routine projects involving the planning, design, reconfiguration, construction, maintenance, validation and alteration of systems, facilities and/or processes. This position will also be required to apply advance and diverse engineering principles to more than one area of engineering (process, unit operations, equipment, devices and materials) in complex process characterization, validation, optimization, scale up or manufacturing support projects.

Project Management

Key responsibilities will include leading the New Product Introduction (NPI) process, Equipment Characterization and Validation for all GMP equipment and processes at the AOH site. Additional responsibilities will include the provision of technical operations support for the continuous improvement of packaging lines capacity and performance, and advisory of technical improvement projects. The role must ensure effective communication throughout the Amgen commercial site network with all partners and deliver on technical improvements.

Technical Lead

Act as the site technical expert lead for FDP combination and non-combination products. Be the technical expert for new process equipment and technology. The candidate is expected to use technical process knowledge and identify the required expertise to resolve process challenges as needed.

Leading the Commissioning, Qualification and Validation of all process and GMP equipment located at AOH. They will own the site master validation plan for GMP equipment and will be responsible to the maintenance and execution of this.

Operational Excellence

Responsible for supporting the delivery of productivity, throughput and general capacity improvements across the AOH site by analyzing, designing, and implementing manufacturing and business process improvements.
Relationships

Build a network of FDP expertise across the Amgen commercial and clinical operations for product assembly, label and packaging. The position is expected to leverage this network in support of GMP technical expertise, performance trending, equipment standardization and trouble shooting/process improvements at AOH.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.

Basic Qualifications:

Doctorate degree & 2 years of Engineering experience

OR

Master's degree & 6 years of Engineering experience

OR

Bachelor's degree or & 8 years of Engineering experience

OR

Associate's degree & 10 years of Engineering experience

OR

High school diploma / GED & 12 years of Engineering experience.

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• Excellent written and verbal communication skills together with ability to work in a team environment.
• Consistent track record of leading and driving multi-functional projects.
• Strong team work, excellent interpersonal and communication skills.
• Direct experience with the manufacturing process for devices, combination products and label & packaging operations.
• Experience of working with Final Drug Product equipment suppliers.
• Ability to work in a highly regulated and ever changing industry.
• Ability to learn and rapidly adapt to new requirements in a fast moving environment.
• An Operational Excellence approach to work product - driving rapid results.
• A passion to deliver an excellent work product and develop others with an infective positive attitude!

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

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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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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.

Salary Range
150,855.00 USD - 185,602.00 USD