Senior Scientist

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is currently seeking a Process Development Senior Scientist for our Commercial Drug Product Technologies Group located Cambridge, MA. This group is responsible for process development and lifecycle management of commercial drug product formulation and fill/finish processes across various modalities (synthetics, large molecule, siRNA, virus, etc.).

The Scientist will provide technical and project leadership while integrating information generated by multi-functional teams to ensure success through the commercialization and life-cycle of the products.

Responsibilities include:

• Serve as a leader on Drug Product Commercialization Teams responsible for planning, designing, executing, and detailing laboratory studies related to drug product design, formulation, and process development in support of commercialization and lifecycle management of both parenteral and oral solid dosage presentations management of parenteral products.
• 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.
• Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering.
• Participate and lead global multi-functional teams working effectively in a highly matrixed team environment to influence and inspire change, efficiency, and foster positive relationships.
• Author and review guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions.
• Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs.
• Mentor and train junior staff with a particular focus on building technical expertise while enabling further career development
• Actively utilize sophisticated IS systems to improve drug product design through faster data availability, using historical information, analyzing large data sets, and statistical analysis.
• Ability to travel domestically and internationally up to 10% of the time.

Basic Qualifications

• Doctorate degree or Doctorate degree completed by March 2020
• Masters degree & 4 years of scientific experience or Bachelors degree & 8 years of scientific experience

Preferred Qualifications

• Advanced degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related subject area
• 5+ years of post-doctoral or industry experience in pharmaceuticals/biotechnology or related field
• Knowledge of/hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations
• Knowledge and awareness of the regulations governing combination product development
• Experience with unit operation for parenteral manufacturing (i.e. filling, filtration, mixing, etc.), specific scale-down model development, characterization, and scale-up
• Understanding of physical/chemical stability of proteins and how process related stress impacts product quality, specifically, the impact of freezing and drying to short- and long-term stability
• Aseptic processing experience and familiarity with cGMPs, ICH guidelines, and pre-approval inspection/audits
• Experience that includes elements of new product development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
• Strong problem solving and effective cross-functional communication skills
• Proven ability to learn and act on dynamic information at a rapid pace

We understand that to successfully sustain and grow as a global enterprise and deliver for patients we must ensure a diverse and inclusive work environment.

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 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.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.