Process Development Scientist - Drug Product
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 to enhance the way data is analyzed and the use of statistical models to inform decisions throughout drug product development. The Scientist will provide technical and project leadership while integrating information generated by cross functional teams to ensure success through the commercialization process.
- 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 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.
- Ability to travel domestically and internationally up to 10% of the time.
- Doctorate degree or Doctorate degree completed by June 2019
- Master's degree & 4 years of scientific experience
- Bachelor's degree & 6 years of scientific experience
- Advanced degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics or related discipline or Statistics degree with experience in pharmaceutical development and manufacturing
- 2+ years of post-doctoral or industry experience in pharmaceuticals/biotechnology or related field
- Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up
- Strong problem solving and effective cross-functional communication skills
- 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
- Proven ability to learn and act on dynamic information at a rapid pace
We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages 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 all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.