Process Development Associate Scientist - Commercial Attribute Sciences
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 Associate Scientist - Commercial Attribute SciencesLive
What you will do
Lets do this. Lets change the world. In this vital role you will be part of a team responsible for supporting commercial analytical methods and deliverables to ensure patient supply. Activities are varied including review/authoring/data verification of regulatory filings, method transfer/validation protocols/reports, method technical reports, and analytical raw data. Flexibility in handing multiple requests and prioritizing critical assignments will be key in delivering to commercial programs. Knowledge of technologies should include chromatography, spectroscopy, and compendia-based methods. A scientific background in Quality and/or Analytical Sciences will be appropriate.Role Responsibilities:
Responsibility for the technical compilation and drafting of method validation/transfer protocols and reports for analytical methods
Perform sample analyses in support of process development studies for drug substance/drug product, for stability programs and investigations.
Participate in method development/remediation, method qualification, method validation/transfer to quality control laboratories as well as from internal Amgen sites
Testing responsibilities will include HPLC, ELISA, SDS- PAGE, capillary electrophoresis, and other general protein analytical methods
Additional duties will include preparation of technical documentation performing in support of process development studies and participating in effective cross-functional collaborations with peers in Quality, Manufacturing and other Process Development groups.
We are all different, yet we all use our unique contributions to serve patients. The scientist professional we seek is a self-starter with these qualifications.Basic Qualifications:
Masters degree and 2 years of directly related experience
Bachelors degree and 4 years of directly related experiencePreferred Qualifications:
Experience in use of multiple analytical techniques
Understanding of product quality attributes
Expertise in analytical troubleshooting and decision-making.
Experience in analytical method development, impurity identification and assessment of post-translational modifications.
Solid understanding of cGMP and regulatory requirements
Familiarity with Laboratory Information Management System (LIMS)
Experience with CMOs or internal quality organizations (GMP, Controlled Document Systems)
Strong technical writing skills
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.
#Operations21Equal 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.