28 days old

Process Development Senior Engineer

Amgen
Cambridge, MA 02138
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  • Job Code
    120722690
Amgen

Job ID: R-99169
Location: Cambridge, MA, US 02139

Are you seeking an opportunity to truly make a difference in the lives of others, and where you can work at the forefront of biotechnology with 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 yet compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Come join us!

The Process Development Senior Engineer will provide technical contributions and support to Amgen's drug product commercialization process, support technology transfer of products from development to commercial production, and advance aseptic manufacturing process development. This role is critical to Amgen's success and will contribute to process development, commercialization, and life cycle management within Amgen's parenteral 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 implementation of characterization studies for multiple parenteral modalities
  • assessment of product impact from manufacturing process, production scale, equipment, and raw material changes
  • author high-quality process technology transfer and other technical documents
  • participate in authoring relevant sections of regulatory submissions to enable successful introduction of new processes and/or production facilities across the parenteral portfolio.


This individual will work directly with clinical/commercial manufacturing in support of ongoing production, new product introductions, new technology introduction, and process optimization. Additionally, 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 catalyst and contributor to Amgen's commercialization development and aseptic process introduction into clinical and commercial facilities, this individual must integrate and successfully utilize knowledge and information generated by multi-functional teams (engineering, analytical, quality, regulatory, clinical and commercial manufacturing) to utilize Amgen platforms and capabilities to ensure success through the commercialization lifecycle.

Responsibilities include:

  • Working with a team of process scientists and/or engineers to design, execute, document, and generate primary data packages related to process development/technology transfer, while applying experience in aseptic processing, equipment, automation and unit operation characterization
  • Supporting continuous improvements in the drug product development process through technological innovation and application of first principles in process engineering
  • Supporting technology transfers of pipeline and commercial products as well as lifecycle management of products for a variety of parenteral modalities
  • Delivering progress reports and presentations to engage with and ensure that management is aware of the current status and progress
  • Participating with global teams, working effectively in a highly matrixed team setting, 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 field of study
  • 5+ years of drug product process development experience in the pharmaceuticals/biotechnology industry
  • 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
  • Strong ability to apply engineering principles to leverage bench and pilot scale models for process performance characterization
  • Solid problem solving and interpersonal skills
  • Experience in a matrix team setting, in particular, successfully interacting with Attribute Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and/or Quality
  • Knowledge of bringing new biotech products to market, across various dosage forms and delivery systems
  • Demonstrated knowledge of formulation, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling and the associated GMP/Device documentation and regulatory filings
  • Proficient with conducting statistical evaluations of data to assess statistical significance, assess potential correlations, evaluate process capability and/or perform Monte Carlo simulations.
  • Ability to learn and take action on dynamic information at a rapid pace
  • Flexibility to travel domestically and internationally up to 25% of the time


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.

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.



PI120722690
Posted: 2020-06-06 Expires: 2020-07-08

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Process Development Senior Engineer

Amgen
Cambridge, MA 02138

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