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Senior Associate Scientist - Pivotal Drug Product Technologies

Company: Amgen
Location: Thousand Oaks
Posted on: March 18, 2020

Job Description:

Amgen is currently seeking a Process Development Senior Associate Scientist for our Pivotal Drug Product Technologies Group in Thousand Oaks, CA. This group is responsible for late stage drug product formulation and fill/finish process development for various biological modalities (e.g. monoclonal antibodies, fusion proteins, RNA, virus). Working closely with a team of scientists and engineers, the successful candidate will apply scientific and engineering principles to advance the technical aspects of Amgen's drug product and process development. Additionally, the position will have focus in the application of data science and statistics to inform decisions throughout drug product development.Responsibilities include:

  • Plan, design, execute, and document laboratory studies related to formulation and fill/finish process development in support of product commercialization and life cycle management
  • Apply basic science/engineering skills and first principle modeling to solve technical problems
  • Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products, as well as, supporting commercial products in lifecycle management.
  • Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software.
  • Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements.
  • Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
  • Deliver progress reports and presentations to ensure management awareness and engagement of the current status, advancement, and future program functional needs.
  • Ability to travel domestically and internationally up to 10% of the time.Basic QualificationsMaster's degree & 3 years of scientific experienceORBachelor's degree & 5 years of scientific experiencePreferred Qualifications
    • Master's degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics or related discipline or Statistics degree with experience in pharmaceutical development and manufacturing.
    • 4+ years of industry experience in pharmaceuticals/biotechnology or related field.
    • Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up.
    • Strong problem solving and effective cross-functional interpersonal skills.
    • Experience with coding/scripting for automated data analysis and modeling.
    • Experience with data visualization tools or packages, such as Tableau or Spotfire.
    • Experience that includes elements of new product development, formulation development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments.
    • Proven ability to learn and act on multifaceted information at a rapid pace.Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.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.

Keywords: Amgen, Thousand Oaks , Senior Associate Scientist - Pivotal Drug Product Technologies, IT / Software / Systems , Thousand Oaks, California

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