Scientist II / Senior Scientist, Process Development

Synthetic Genomics   •  

La Jolla, CA

5 - 7 years

Posted 240 days ago

This job is no longer available.

At Synthetic Genomics, Inc., we are dedicated to developing and commercializing genomic-driven solutions to address global challenges. We are currently seeking a Scientist II or Senior Scientist to join our fast-growing, dynamic and collaborative team in La Jolla, CA. 

   SGI is seeking a Scientist II or Senior Scientist to join the Viral Systems team which focuses on the development of novel RNA-based vaccines and therapeutics in the fields of infectious disease and cancer. The successful candidate will play a key role in Process Development activities associated with the RNA platform. This includes production optimization, purification and analytical analysis of in vitro transcribed RNA. The role will also involve preparation of standard operating procedures (SOP) and batch production records (BPR) to support the over-all quality of in vitro synthesized RNA.  This position requires demonstrated molecular biology research skills and a strong understanding of product Quality requirements as they relate to biologics product development.

Required skills:

  • Working knowledge of Quality Assurance and Quality Control in a biologics production setting is required
  • Foundation of knowledge in process development is highly preferred
  • Expertise in assay development and validation to support biologics product development is required
  • Experience in preparation of SOP and BPR documents highly desirable
  • Time management, prioritization, and planning skills with demonstrated ability to execute on multiple projects simultaneously
  • Technical leadership to research associates in cross-disciplinary team environments
  • Ability to lead small team in matrixed environment
  • Ability to represent SGI at scientific presentations and meetings

Required experience:

  • PhD in Microbiology, Virology or related field
  • Minimum of four to eight-years biotechnology, industrial or other process development experience
  • Experience working from and in preparation of SOP and BPR documents is highly preferred
  • Direct, hands-on experience generating analytical assay development, optimization and validation data packages in accordance with regulatory requirements
  • Track record of successful research and experience in process development required; demonstrated experience with DOE approach preferred
  • Execution and oversight of technical transfer of validated processes to GMP biologics manufacturing facilities
  • Excellent communication and interpersonal skills to facilitate internal and external scientific interactions
  • Organized, highly motivated, innovative professional with critical thinking and problem-solving skills to independently design, execute, troubleshoot and interpret experiments
  • Previous experience with RNA highly preferred