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Amgen Process Development Senior Scientist – Pivotal Drug Product in Cambridge, Massachusetts

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen is seeking a Process Development Senior Scientist for our Pivotal Drug Product Technologies Group in Cambridge, MA. This group is responsible for late stage drug product formulation and fill/finish process development for Amgen’s late stage large molecule pipeline. The Senior Scientist will provide technical and project leadership while integrating information generated by multi-functional teams to ensure success through the commercialization process.

Responsibilities include:

  • Leading multi-functional Drug Product Commercialization Teams responsible for formulation development, fill/finish process development/characterization, technology transfer, and regulatory authoring for pipeline and lifecyle management projects.

  • Overseeing and participating in the planning, design, implementation and documentation of formulation and fill/finish process development studies.

  • Leading a team of engineers and scientists to advance program and functional objectives

  • Expanding the utilization of sophisticated IS systems to improve drug product design through faster data availability, using historical information, analyzing large data sets, and statistical analysis.

  • Authoring and reviewing guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.

  • Driving continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering.

  • Serving as a leading authority in drug product technologies and help drive standard methodologies and technical advancements

  • Delivering progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs.

  • Working effectively in a highly matrixed team environment to advance programs inspire change, improve efficiency, and foster positive relationships.

  • Ability to travel domestically and internationally up to 10% of the time.

Basic Qualifications

  • Doctorate degree & 2 years of scientific experience or

  • Master’s degree & 5 years of scientific experience or

  • Bachelor’s degree & 7 years of scientific experience

Preferred Qualifications

  • Advanced degree in Engineering, Pharmaceutics, Biotechnology, Material Science or related subject area

  • 8+ years of experience in pharmaceuticals/biotechnology.

  • 5+ years of experience that includes elements of formulation and fill/finish process development, process characterization, technical transfers to manufacturing sites, and statistical design and analysis of experiments, and regulatory authoring.

  • Leadership of highly technical specialists with demonstrated results driving forward pipeline and lifecycle management programs

  • Experience in drug product regulatory strategy, RTQs, and agency engagement.

  • Knowledge of, and hands-on experience with, bringing new biotech products to market, across various dosage forms and device delivery systems.

  • Experience participating and leading global multi-functional teams

  • Superior 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.

  • Strong problem solving and effective multi-functional communication skills.

  • Demonstrated ability to learn and act on dynamic information at a rapid pace.

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.

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 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.​