Process Development Scientist
Thousand Oaks, California
Expiry Date :
Fri, 06 Nov 2020 23:59:59 GMT
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Location Thousand Oaks, CA, US
Posted Oct 05, 2020
Discipline Engineering, Manufacturing & Production, Process
Hotbed Biotech Beach, Ideal Employer
Required Education Bachelors Degree
Position Type Full time
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A biotechnology pioneer since 1980, Amgen has grown to be the world’s largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
The Process Development Scientist will be responsible for supporting method trouble shoooting issues across various analytical platforms, which may include Microbiology, PCR, Viral, and general compendial methods related to microbial control.
In addition to hands-on involvement with method trouble shooting, the incumbent will be involved with the evaluation of new technologies related to rapid microbiological methods and providing technical expertise to the manufacturing sites in relation to the microbiological methods. Extensive experiences in compendial and alternative endotoxin test methods are preferred.
This individual would be a part of a team that would support methods in various stages of the product life cycle. This team would support programs/methods at locations throughout the company. The Scientist collaborates with representatives from key functions within Process Development, Manufacturing and Quality.
Master’s degree and 4 years of Scientific experience
Bachelor’s degree and 6 years of Scientific experience
Excellent written and oral communication skills for the timely documentation, presentation and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment.
Advanced ability to critically analyze and interrogate various analytical data sets to drive and influence the investigational process
Advanced root cause analysis capabilities including leading advanced and complex events
Advanced ability to propose and lead new scientific imperatives/initiatives
Highly proficient in an investigational laboratory setting within a pharmaceutical or biotechnology company
Expert understanding and experience on analytical testing and sample handling
Advanced understanding and hands-on experience in various analytical platform such as compendial microbial methods, rapid methods for microbial detection/identification and advanced technologies for detection of bacteria and viruses.
Advanced experience in working closely with scientific and manufacturing subject areas across process development, clinical, and commercial operations
Familiarity with cGMP regulations, FDA and EU regulations and guidelines
Experience designing and running process development microbiology laboratory
Global regulatory and pharmacopeia compliance experience related to microbiological methods
Prior experience in Microbiological Quality at both the technical and management levels providing support for microbiological methods
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.
We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.
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. Come 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.
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