Amgen Process Development Sr Associate - Pivotal Drug Product in Cambridge, Massachusetts
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.
PROCESS DEVELOPMENT SR ASSOCIATE
What you will do
Let’s do this. Let’s change the world. In this vital role you will work within the Pivotal Drug Product Technologies Group in Cambridge, MA. This group 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.
Participate in the planning, design, execution, and documentation of studies related to drug product design, formulation development, and process development in support of commercialization and life cycle management of biologics.
Author and review technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
Actively utilize sophisticated IS systems to improve drug product design through faster data availability, using historical information, analyzing large data sets, and statistical analysis.
Create visualizations to enable business application of data analysis.
Explore and evaluate new digital tools and approaches to improve the team’s developmental and operational capabilities.
As needed, provide support 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.
Support standardization and optimization of departmental practices by contributing to guideline documents.
Participate in global cross-functional teams working optimally in a highly matrixed team environment to progress product development.
Deliver progress reports and presentations to ensure management awareness and engagement of the current status, progress, and future program and functional needs.
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 individual with these qualifications.
Bachelor’s degree and 2 years of scientific experience
Master’s degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related field.
2+ years of experience in pharmaceuticals/biotechnology that includes elements of new product development, process characterization, formulation development, equipment design and implementation, technology transfers, statistical process control (SPC), and statistical design and analysis of experiments.
Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down models, characterization, and scale up.
Understanding of physical/chemical stability of proteins and how process related stress impacts molecule attributes and product quality.
Proficiency in at least one statistical software package (such as SIMCA or JMP).
Experience with coding/scripting for automated data analysis and modeling to enable better access and standardization across the function.
Strong problem solving and effective cross-functional communication skills.
Demonstrated 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, so we 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.
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.