Senior Engineer - Drug Product Process Engineering
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.
Senior Engineer - Commercial Drug Product - Drug Product Process EngineeringLive
What you will do
Lets do this. Lets change the world. In this vital role you will provide technical feedback and support to Amgens 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 Amgens success and will be a key contributor to drug product and process development, commercialization, and life cycle management of Amgens parenteral and oral solid dosage form product portfolio.
The Senior Engineer will operate in product and process development and/or manufacturing environments and will own the design and completion of characterization, evaluation of product impact from manufacturing process, production scale, equipment, and raw material changes, author high-quality process technology transfer and other technical documents, and participate in authoring relevant sections of regulatory submissions to enable successful introduction of new processes and/or production facilities across the parenteral and oral solid dosage form portfolio. You will work directly with clinical and commercial manufacturing in support of on-going production, new product introductions, new technology introduction, and process optimization. The Senior Engineer must apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering (equipment, automation, chemical, mechanical) principles to support non-conformance investigations and development of corrective/preventive actions. As a key contributor to Amgens commercialization development and process introduction into clinical and commercial facilities, the Senior Engineer must integrate and successfully utilize knowledge and information generated by multi-functional (engineering, analytical, quality, regulatory, clinical and commercial manufacturing) teams to utilize Amgen platforms and capabilities to ensure success through the commercialization lifecycle.
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 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 oral solid drug product manufacturing, for all unit operations including but not limited to encapsulation, blending, milling, granulation, drying, compaction and coating.
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
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:
Masters degree and 3 years of Operations or Process Development experience
Bachelors degree and 5 years of Operations or Process Development experience
Associates degree and 10 years of Operations or Process Development experience
High school diploma / GED and 12 years of Operations or Process Development experience
M.S. 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, oral solid dosage form 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
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 Applicants 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.