Process Development Associate Scientist - 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 Scientist - Pivotal Drug ProductLive
What you will do
Lets do this. Lets change the world. In this vital role you will be responsible for late stage drug product formulation and fill/finish process development for various biological modalities (e.g. monoclonal antibodies, bispecific T-cell engagers (BiTEs) and fusion proteins). The Associate Scientist will work closely with a team of engineers and scientists responsible for the technical aspects of Amgens drug product commercialization and lifecycle management. Additionally, the position will have focus in the application of data science and statistics to inform decisions throughout drug product development.Responsibilities include:
Plan, design, execute, and document laboratory studies related to formulation and fill/finish process development in support of product commercialization and life cycle management
Apply basic science/engineering skills and first principle modeling to solve technical problems
Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products, as well as, supporting commercial products in lifecycle management.
Perform data analysis using sophisticated statistical/analytical techniques with a proficiency in statistical analysis software.
Provide support, as needed, 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.
Author and review technical protocols, reports, and regulatory sections in support of INDa and marketing application submissions.
Contribute to progress reports and presentations to management on technical challenges, proposed solutions and results
What we expect of you
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 2years of scientific experience
Bachelors degree and 4 years of scientific experiencePreferred Qualifications:
Masters degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics or related subject area.
2+ years industry experience in pharmaceuticals/biotechnology
Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up
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.
Understanding of physical/chemical stability of proteins and how process related stress impacts product quality, specifically, the impact of freezing and drying to short- and long-term stability
Ability to learn and act on dynamic information at a rapid pace.
Strong organizational skills with 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.