Process Development Scientist - Pre-Pivotal Drug Substance
Amgen is seeking a highly motivated Scientist to join the Genetic Characterization/ Cell Line Development group in Pre-Pivotal Drug Substance organization at Amgen headquarters in Thousand Oaks, CA.
The Scientist will utilize their deep expertise in molecular biology for the design and creation of genetic constructs for recombinant protein production, including vector design and cloning of complex multi-domain proteins. He/She will also be responsible for performing detailed genetic characterization of engineered cell lines and documenting results for IND and Marketing Applications. The candidate will plan, perform, and analyze experiments, and drive innovation and implement new technologies to improve the development and characterization of Amgen's production cell lines.
- Independently design, engineer, and assemble protein and antibody expression constructs and expression vectors for diverse protein classes and expression hosts.
- Perform, and analyze experiments utilizing molecular biology techniques such as DNA and RNA isolation and purification, restriction analysis, PCR, RT-PCR, sequencing and genotyping of manufacturing cell lines.
- Develop and implement innovative molecular technologies to improve efficiency and speed of processes
- Generate scientific results that support the generation of regulatory submissions, publications, patents, and participate in internal and external scientific meetings
Master's degree and 4 years of scientific experience
Bachelor's degree and 6 years of scientific experience
- Proficiency in molecular biology techniques
- Doctorate degree and 2 years industry experience in molecular and cellular biology or related field
- Expertise in advance molecular biology and genetic characterization techniques including DNA sequencing and analysis (Sanger and NGS), mRNA isolation and analysis, RNA-Seq, and quantitative PCR technologies. Experience in designing and executing cloning strategies using Golden Gate or seamless cloning techniques is highly desirable.
- Fundamental understanding and experience in mammalian protein expression and expression vector design
- Experience with cell culture, cell line development and protein expression
- Experience with bioinformatics and handling of large datasets is highly preferred
- Knowledge of established genome editing technologies is desirable.
- Experience with automation and high throughput sample processing
- Strong communication and interpersonal skills, and the ability to work flexibly in a cross-functional team environment
- Demonstrated track record of independent critical thinking and scientific achievement in research, exemplified by a strong publication and/or patent record
- Excellent organization skills. The candidate is expected to document all aspects of experiments performed in support of regulatory filings and Health Agency interactions