Amgen Process Development Associate Scientist 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 Associate Scientist
What you will do
Let’s do this. Let’s change the world. In this role the incumbent will be developing, qualifying and transferring innovative and fit-for-purpose quantitative assays for the measurement of DNA, proteins and other biological analyzes for manufacturing process development.
Developing and implementing pioneering and fit-for-purpose analytical methods for: impurity release testing.
Preparing technical reports for investigations, product and impurity characterization, and regulatory submissions
Generating, analyzing, and interpreting analytical data to support: product development investigations, and regulatory submissions
May participate or contribute to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation
Keeps current in analytical development field including literature and technology development for groundbreaking and regulatory activities
Supporting analytical projects involving method development, qualification, and transfer
Provides critical evaluation of analytical data and results to support: product development (for Process Development, Quality, etc.), investigations and regulatory submissions
Participates in and contributes to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates and documentation.
Providing critical evaluation of analytical data and results to support: product development (for Process Development, Quality, etc.), investigations and regulatory submissions
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek will possess these qualifications.
Master’s degree & 2 years of Scientific experience
Bachelor’s degree & 4 years of Scientific experience
Experience and expertise with molecular biology, particularly qPCR and DNA isolation.
Experience and expertise with protein assays, particularly ELISA as well as most common formats for measuring protein-protein interactions.
Experience and expertise with Microsoft Office software, particularly Word, PowerPoint and Excel.
Experience with regulatory filings (IND, BLA, and NDA) and ICH Guidelines
Innovation – positive approach to challenges; champions new insights and initiatives; brings out and applies others’ creativity to improve unit performance
Client orientation– establishes effective and adaptable relationships with all clients; translates client requirements into work design; ensure value is delivered
Communication – establishes and maintains effective communication mechanisms to keep staff appropriately advised; bridges communication between individuals, units and other organizations as necessary
Social skills – communicates optimally, using appropriate tact and sensitivity; makes others feel respected, valued and understood
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.
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.