Amgen Process Development Scientist - Commercial Drug Product in Cambridge, Massachusetts
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
PROCESS DEVELOPMENT SCIENTIST - COMMERCIAL DRUG PRODUCT
What you will do
Let’s do this. Let’s change the world. In this vital scientific role you will provide technical and project support while integrating information generated by cross functional teams to ensure success through the commercialization and life-cycle of the products.
Amgen is currently seeking a Process Development 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.)
Support Drug Product Commercialization Teams responsible for planning, designing, executing, and documenting 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 on global cross-functional teams working effectively in a highly matrixed team environment to influence and drive change, efficiency, and foster strong 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.
Actively utilize advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis.
Ability to travel domestically and internationally up to 10% of the time.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a collaborative team-player with these qualifications.
Masters degree & 4 years of scientific experience
Bachelors degree & 6 years of scientific experience
Advanced degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related discipline
2+ 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
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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.