Thousand Oaks, CA, US
Nov 05, 2020
Required Education
Bachelors Degree
Position Type
Full time
Amgen is currently seeking a Process Development Scientist for our Pivotal Drug Product Technologies Group in Thousand Oaks, CA. This group is responsible for late stage drug product formulation and fill/finish process development for various biological modalities (large molecule, RNA, virus). Additionally, the position requires expertise in data analysis and the use of statistical models to inform decisions throughout drug product development. As a Scientist in this role you will provide technical and project leadership while integrating information generated by multi-functional teams to ensure success through the commercialization process. You will also need to stay ahead of the latest developments/trends in the industry and scientific community to foster innovation and to meet future business needs! This position requires (up to 10%) travel to domestic and international sites.

Key Responsibilities:
  • Work independently, taking ownership of projects and self-managing work packages with appropriate communication and escalation
  • 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 life-cycle management
  • Manage multiple activities in parallel to drive project plans to completion, meeting project timelines and milestones
  • Perform data analysis using advanced 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 guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
  • Deliver progress reports and presentations to ensure management awareness and engagement of the current status, advancement, and future program functional needs
  • Find efficient approaches to tackle relevant problems and will thereby deliver value-adding and agile solutions to Amgen Process Development
  • Work in a cross-functional team environment, adeptly collaborating liaising with colleagues within Drug Product Technologies, as well as partner organizations across Operations
  • Ability to travel domestically and internationally up to 10% of the time.

Basic Qualifications:
Doctorate Degree or Doctorate Degree completed by October 2020
Master's Degree and 4 years of scientific and/or operations experience
Bachelor's Degree and 6 years of scientific and/or operations experience

Preferred Qualifications:
  • Advanced degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics or related discipline with experience in pharmaceutical development and manufacturing.
  • 5+ years of related experience
  • Experience in designing drug product unit operations such as freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection
  • Knowledge of/hands-on experience with formulation and commercial process development for liquid and lyophilized drug products
  • Strong skills in applying fundamental engineering and scientific principles to process design
  • Understanding of physical/chemical stability of proteins and how process related stress impacts product quality
  • Project management skills, including the ability to balance multiple projects and evaluate project resource requirements.
  • Experience with coding/scripting for automated data analysis and modeling
  • 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
  • Ability to learn and act on dynamic information at a rapid pace

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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 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 accommodation.

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.