Engineer

JOB ID: R-187172 LOCATION: US - Massachusetts - Cambridge WORK LOCATION TYPE: On Site DATE POSTED: Apr. 25, 2024 CATEGORY: Process Development SALARY RANGE: 87,178.00 USD - 107,393.00 USD

HOW MIGHT YOU DEFY IMAGINATION?

You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Engineer

Live

What you will do

Let's do this! Let's change the world! In this vital role you will be responsible for the technology transfer and commercial support of biologics drug substance processes across the network, including both the Amgen manufacturing network and/or Contract Manufacturing Organizations. You will work as a member of a team of engineers and scientists, as you use engineering principles to implement manufacturing process in a cGMP environment.

• Provide solutions to a variety of technical problems of moderate scope and complexity to enable Technology Transfer of various clinical and commercial molecules.

• Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.

• Perform assignments that have clear and specific objectives and require investigation of limited number of variables.

• Initiate and complete routine technical tasks associated with Technology Transfer.

• Routinely monitor manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting mentorship.

• Apply engineering principles and statistical analysis, including design of experiments, in-order to address processing issues and evaluate opportunities for process improvements

• Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for processes and/or system modifications.

• Communicate and collaborate with technical and management staff within Manufacturing, Process Development, and Quality departments.

• Support non-standard shift organization and extended hours, as per business needs.

• Up to 15% travel is possible - primarily domestic (but could be international)

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an engineer with these qualifications.

Basic Qualifications:

• High school diploma / GED and 8 years of Engineering or Operations experience OR
• Associate's degree and 6 years of Engineering or Operations experience OR
• Bachelor's degree and 2 years of Engineering or Operations experience OR
• Master's degree

Preferred Qualifications:

• Education background in Chemical Engineering, Bioengineering or Biotechnology

• 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing processes.

• Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale

• Experience working with commercial manufacturer of biologics using single use technology

• Basic understanding cGMP requirements; Experience related to upstream and/or downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP). This includes technical support for nonconformance investigations and other commercial support activities

• Experience in working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration among others for a variety of biological molecules. Experience working with data and digital tools preferred.

• Proficient re: the analysis of data generated from an array of analytical techniques

• Regulatory knowledge and interactions and project management skills

• Strong oral and verbal communication and presentation skills

• Fluency in foreign languages preferred

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

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.

Amgen offers a Total Rewards Plan comprising 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 including:

• 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 and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.

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