HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Engineer - Commercial Drug Product - Process Engineering and ValidationLive
What you will do
Lets do this. Lets change the world. In this vital role you will join Drug Product Process Engineering team that is part of Commercial Drug Product Technologies at Amgen and will be a key contributor to drug product process development, commercialization, and life cycle management of Amgens parenteral product portfolio. You will integrate the knowledge and information generated by multi-functional teams with Amgens platforms and clinical and/or commercial manufacturing capabilities to ensure success through the commercialization lifecycle. Operate in product/process development and aseptic manufacturing environments in a highly matrixed multi-functional manner.
Work with a team of process scientists and/or engineers to design, execute, document, and generate primary data packages related to process development and technology transfer, while developing and applying their experience in aseptic processing, equipment, automation and unit operation characterization
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
Support make-a-batch exercises to determine facility fit and identify gaps
Design and execute offline and on-site drug product characterization studies
Evaluate product impact due to manufacturing process, production scale, equipment, and raw material changes
Author and/or own high-quality process technology transfer and other technical documents
Dynamic, matrixed organization and collaboration work with a broad array of partners on a routine basis, providing visibility to those other areas of the business and how these functions work together to meet organizational goals.
Operational efficiency and business skills application this role provides an opportunity to apply core technical skills to Amgens process development operations.
Process development Provide technical feedback and support to the drug product tech transfer process by executing development studies including filling recipe development, lyophilization process scale-up etc.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The engineer professional we seek is a self-starter with these qualifications:
Bachelors degree and 2 years of Operations or Process Development experience
Associate's degree and 6 years of Operations or Process Development experience
High School Diploma / GED and 9 years of Operations or Process Development experience
Preferred Qualifications :
M.S. in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related field
Experience in a role that working with multi-functional groups to achieve results.
Highly proficient in presentation skills and the ability to draft technical documents.
Familiarity with aseptic processing, drug product manufacturing, cGMPs, statistical design, analysis of experiments, and process characterization
Fill/finish 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
Knowledge of formulation, filling, lyophilization, visual inspection, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling and the associated GMP/Device documentation and regulatory filings
Some of the vast rewards of working here
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.
Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
External Candidates Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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Please note that you should be in your current position for at least 16 months before applying to internal positions. Staff must notify their current manager if invited for an interview. In addition, Staff are ineligible to apply for open positions if (a) their performance is currently being managed on a performance improvement plan (PIP) or other locally utilized formal coaching document or (b) their most recent performance rating was not a Partially Meets Expectations or higher. Please visit our Internal Transfer Guidelines for more detailed information
#Operations21Equal Opportunity Statement
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 a 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 an accommodation.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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, or disability status.