Process Development Associate Scientist
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 SCIENTISTLive
What you will do
Lets do this. Lets change the world. In this vital Associate Scientist role you will Based in Thousand Oaks, CA, the role of Process Development Sr. Associate in Pivotal Drug Product Technologies will provide support for Amgens large molecule (biologics) drug product formulation and fill/finish process development. The Sr. Associate will be responsible for performing formulation studies, evaluating the impact of process stresses on Drug Product attributes/stability, and process parameter definition for various fill finish unit operations. In addition, this role will focus on data analytics, statistical modeling, and data visualization.Responsibilities include:
- 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 various modality biologics (antibody, BiTE, other proteins, viruses, RNA).
- Perform analytical characterization supporting formulation attribute and stability assessments using chromatography and biophysical characterization tools (SE-HPLC, CE-SDS, DSC, NMR, HIAC).
- Author and review technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
- Actively utilize advanced IS systems to improve drug product design through faster data availability, leveraging 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 techniques to improve the teams 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
- Deliver progress reports and presentations to ensure management awareness and engagement of the current status, progress, and future program and functional needs.
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 driven and collaborative team-player with these qualifications.Basic Qualifications
- Masters degree and 3 years of scientific experience
- Bachelors degree and 5 years of scientific experience
- Associate degree and 9 years of scientific experience
- High school diploma / GED and 12 years of scientific experience
- Masters degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related subject area
- 5 or more 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 characterization of drug product formation and fill/finish unit operations (i.e. freeze/thaw, formulation, mixing, filtration, filling, and inspection)
- Understanding of physical/chemical stability of proteins and how process related stress impacts molecule attributes and product quality
- In addition to proteins, experience with alternate modalities (RNA or virus modalities) is a plus
- Proficiency in at least one statistical software package (such as SIMCA or JMP)
- Experience with data visualization tools or packages, such as Tableau or Spotfire
- Experience with coding/scripting for automated data analysis and modeling to enable better access and standardization across the function
- Aseptic processing experience and familiarity with cGMPs
- Regulatory filings and compliance issues for sterile injectable products
- Strong problem solving and effective cross-functional communication skills.
- 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 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.