- Entry level
- No Education
- Salary to negotiate
- Thousand Oaks
The Scientist will be joining Core Technologies group within Development Supply Chain, Process Development, at Amgen. This group’s mission is to provide technical leadership in implementing/advancing novel manufacturing technologies, and supporting continuous improvement in the clinical/commercial GMP drug product manufacturing facility in Thousand Oaks, CA. This role is crucial for Amgen’s success and it will be a key contributor to ensure we reliably supply medicines to our patients.
Specific responsibilities include, but are not limited to:
Lead the development and implementation of the next generation of manufacturing equipment, systems and technologies which will be applied to support advancements in drug product manufacturing.
Apply scientific principles (e.g. fluid dynamics, heat/mass transfer, data analytics, modeling etc.) to advance state-of-the art process, automation and analytical technologies.
Advance new technologies in aseptic filling, lyophilization and visual inspection operation
Technical problem solving and document authoring related to development and characterization of innovative instrumentation, robotic systems and methods in support of drug product manufacturing
Develop workflows and processes to enable seamless integration of novel technologies into existing platforms.
Lead initiatives to improve the value of technical data packages and to do so with enhanced speed and efficiency.
Operate well in a matrixed environment. Collaborate successfully cross-functionally to implement technologies and solve technical challenges in support of large and small molecule modalities across the Amgen network.
The candidate will be expected to stay current on the latest developments in the industry and scientific community to foster innovation and to meet future business needs.
Travel: up to 20%
Master’s degree and 4 years of scientific experience
Bachelor’s degree and 6 years of scientific experience
Advanced degree in Engineering, Pharmaceutical Sciences, or Biotechnology or related discipline
Experience in biologics fill finish manufacturing process, and some automation
Good knowledge of aseptic processing/manufacturing and experience supporting GMP manufacturing
Understanding of process related stresses that impact the quality and stability of biologics
The ability to use scientific/engineering principles to leverage bench and pilot scale models for process performance characterization
Use of gap analysis, root cause analysis, and risk assessment tools (e.g. Fish bone diagrams, FMEA, etc.)
Familiarity with Design of Experiments (DOE) and Quality by Design (QbD) principles
Familiarity with cGMPs, regulatory filings, and compliance issues for sterile injectable products manufactured by aseptic processing
Experience in a matrix team environment
Strong communication skills (written and verbal), relationship building, organizational, technical problem solving, and ability to regularly interact with staff from other functions
Ability to learn and act on dynamic information at a rapid pace
Amgen is committed to unlocking the potential 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.
About the company
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.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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