AddressHOW 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.
careers.amgen.com
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.
