14 days old

Senior Engineer - Drug Product Process Engineering

Amgen
Cambridge, MA 02138
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  • Job Code
    126027573
Amgen

Job ID: R-108099
Location: Cambridge, MA, US

The Process Development Senior Engineer, Drug Product Process Engineering, will provide technical input 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 important 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 & oral solid dosage form product portfolio. This position is based in Cambridge, MA at the Amgen Massachusetts site (AMA).

The Senior Engineer will operate in product and process development and/or manufacturing environments and will be responsible for the design and execution 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. The Senior Engineer 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 Amgen's commercialization development and process introduction into clinical and commercial facilities, the Senior Engineer must integrate and successfully utilize knowledge and information generated by cross functional (engineering, analytical, quality, regulatory, clinical and commercial manufacturing) teams to utilize Amgen platforms and capabilities to ensure success through the commercialization lifecycle.

Responsibilities include :
  • 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 expert, to provide leadership and solutions when troubleshooting 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 cross-functional teams, working effectively in a highly matrixed team environment to advance programs through clinical manufacturing and the commercialization process

Basic Qualifications:

Doctorate degree

OR

Master's degree & 3 years of Operations or Process Development experience

OR

Bachelor's degree & 5 years of Operations or Process Development experience

OR

Associate's degree & 10 years of Operations or Process Development experience

OR

High school diploma / GED & 12 years of Operations or Process Development experience

Preferred Qualifications:
  • M.S. in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related discipline
  • 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 leverage bench and pilot scale models for process performance characterization
  • Problem solving and communication skills
  • 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


Join Us

If 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.



PI126027573
Posted: 2020-11-14 Expires: 2020-12-16

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Senior Engineer - Drug Product Process Engineering

Amgen
Cambridge, MA 02138

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