Senior Associate Pivotal Drug Product
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
PROCESS DEVELOPMENT SR. ASSOCIATELive
What you will do
Lets do this. Lets change the world. In this vital role you will work closely with a team of engineers and scientists responsible for the technical aspects of Amgens drug product commercialization and lifecycle management. Based in Cambridge, Massachusetts, Amgen is seeking a Process Development Senior Associate for Pivotal Drug Product Technologies Group to support 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).Responsibilities include:
- Participate in planning, designing, implementing, and documenting studies related to drug product formulation and process development of various biologics (antibody, BiTE, other proteins)by applying basic science/engineering skills and prior knowledge
- Evaluate product quality and process performance through analytical testing (e.g. protein conc, pH, U/HPLC, rCE, particle analysis, moisture content)
- Apply advanced digital tools to automate data structuring, analyze large and diverse datasets and build intuitive visualizations.
- Operate and maintain automated lab equipment in support of formulation and process scale up study and material generation
- Author/review technical protocols and reports and perform data verification
- Participate in team meetings by sharing study designs, results and technical challenges
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The biotech/pharma professional we seek is a collaborative team-player with these qualifications.Basic Qualifications:
Bachelor's Degree and 2 year of Scientific, Engineering or Operations experiencePreferred Qualifications:
- Degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related subject area
- 2+ years of experience in pharmaceuticals/biotechnology that includes formulation development, scale up process development, and technology transfer
- Knowledge of Drug Product unit operations (i.e. ultrafiltration/diafiltration, filling, filtration, mixing, etc.) and experience with relevant analytical techniques (i.e. SEC, CEX, HIAC, MFI)
- Ability to learn new techniques and instrumentation, perform multiple tasks simultaneously, keep accurate records, adhere to instructions, and follow company policies.
- Experience with programming (e.g. Python, R, MATLAB) and database languages (e.g. SQL), as well as data visualization tools (e.g. Tableau, Spotfire) is a plus
- Ability to learn and rapidly adapt to new requirements in a fast paced environment
- Critical thinking, problem solving and independent research skills
- Good organizational skills with strong attention to detail
- Excellent communication (oral and written)
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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith 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.
careers.amgen.comEqual 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.
Join UsIf 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.