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Amgen Senior Engineer - Drug Product Process Engineering in Cambridge, Massachusetts

Job Description

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.

Senior Engineer - Drug Product Process Engineering

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide technical feedback and support to Amgen’s drug product commercialization process for multiple product modalities, by supporting technology transfer of products from development to clinical/commercial production. This role is critical for Amgen’s success and will be a key contributor to drug product and process development, commercialization, and life cycle management of Amgen’s parenteral and oral solid dosage form product portfolio.

Responsibilities:

  • Work with a team of process scientists and/or engineers to design, implement, document, and generate primary data packages related to process development and technology transfer, while applying their experience in aseptic processing, equipment, automation, and unit operation characterization

  • Act as a drug product technical specialist, to provide leadership and solutions for parenteral product manufacturing, for all unit operations including but not limited to formulation, filtration, filling, capping, lyophilization and visual inspection.

  • Support continuous improvements in the drug product development process through technological innovation and application of first principles in process engineering

  • Support technology transfers of pipeline and commercial products as well as lifecycle management of products for a variety of parenteral modalities

  • Deliver progress reports and presentations to engage with and ensure that management is aware of the current status and progress

  • Participate in global multi-functional teams, working effectively in a highly matrixed team environment to advance programs through clinical manufacturing and the commercialization process

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The senior engineer professional we seek is a self-starter with these qualifications:

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 2 years of Operations or Process Development experience

Or

Bachelor’s degree and 4 years of Operations or Process Development experience

Or

Associate’s degree and 8 years of Operations or Process Development experience

Or

High school diploma / GED and 10 years of Operations or Process Development experience

Preferred Qualifications:

  • M.S. or PhD in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related field

  • 5+ years of drug product process development experience in the pharmaceuticals/biotechnology industry

  • Familiarity with aseptic processing, drug product manufacturing, drug product manufacturing, cGMPs, statistical design, analysis of experiments, and process characterization

  • Process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools

  • The ability to use engineering principles to demonstrate bench and pilot scale models for process performance characterization

  • Experience in a matrix team environment, in particular interacting with Attribute Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and/or Quality

  • Knowledge of bringing new products to market, across various dosage forms and delivery systems

  • Knowledge of associated GMP/Device documentation and regulatory filings

  • Experience with conducting statistical evaluations of data to evaluate statistical significance, assess potential correlations, evaluate process capability and/or perform Monte Carlo simulations.

  • Ability to learn and act on dynamic information at a rapid pace

  • Ability to travel domestically and internationally up to 25% of the time

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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