Amgen Process Development Scientist - Pivotal Drug Product in Cambridge, Massachusetts
HOW MIGHT YOU DEFY IMAGINATION?
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Process Development Scientist - Pivotal Drug Product
What you will do
Let’s do this. Let’s change the world. In this vital role, you will be part of our Pivotal Drug Product Technology Group in Cambridge, MA which is responsible for late-stage drug product formulation and fill/finish process development for large molecule modalities (e.g. monoclonal antibodies, bispecific T-cell engagers (BiTEs), and fusion proteins). 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.
Lead the design and planning of laboratory studies related to formulation and fill/finish process development by applying basic science/engineering skills, first principle modeling, and prior knowledge
Execute and document laboratory studies with a high degree of technical rigor
Develop technical project plans to generate comprehensive data packages in support of commercial formulation/process development and process characterization
Author and review guideline documents, technical protocols, reports, and regulatory sections in support of IND and marketing application submissions
Lead multiple activities in parallel to drive project plans to completion, meeting project timelines, and achievements
Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline and lifecycle management programs
Perform data analysis using advanced statistical/analytical techniques with proficiency in statistical analysis software
Deliver progress reports and presentations to management on technical challenges, proposed solutions, and results
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 outstanding contributions to serve patients. The hard-working professional we seek is collaborative with these qualifications.
Master’s degree and 3 years of process development or scientific experience Or
Bachelor’s degree and 5 years of process development or scientific experience
Advanced degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics, or related field
2+ years of post-doctoral or industry experience in pharmaceuticals/ biotechnology or related field
Knowledge of/hands-on experience with formulation and commercial process development for liquid and lyophilized drug products
Experience with the unit operation (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 on short- and long-term stability
Strong problem-solving and effective multi-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 dynamic information at a rapid pace
Some of the vast rewards of working here
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
A 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—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. 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.
We will ensure that individuals with disabilities are provided 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 accommodation.
Amgen requires all staff in the United States, Puerto Rico and Canada 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.