Senior Scientist Of Biochemistry And Molecular Biology-Analytical Development
Raleigh , NC 27601
Posted 1 week ago
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The Senior Scientistof Biochemistry and Molecular Biologyis a critical member of the CMC Analytical team and is responsible for designing, executing and overseeing day-to-day scientific activities relating to the molecular and biochemical assay development for new gene therapy candidates to enable their cGMP production and release. The incumbent will be a key contributor in the efforts of the analytical development function to develop/optimize/qualify/transfer immuno-, enzymatic, and cell-based analytical methods suitable for release and characterization of gene therapies and ensure scientific rigor in the release and stability testing of clinical trial materials, while meeting timelines. This individual will work in partnership with Non-Clinical Development, Upstream/Downstream Process/Formulation Development functions to deliver products for clinical testing and serve as a key technical expert on analytical assays in communications with internal stake holders and external partners.
- Develop, optimize, qualify and transfer phase-appropriate analytical assays to support non-clinical, CMC, and clinical development of gene therapy drug candidates
- Design and execute experiments for qualitative and quantitative characterization of recombinant AAV-based gene therapy drug substance and drug product
- Supports process optimization during CMC development by providing key analytical information in regard to the quality attributes of the in-process materials
- Troubleshoot process development issues, out-of-specification, and other deviations through detailed analysis using biochemical/biophysical, molecular and other analytical techniques.
- Design and execute forced degradation and stability program
- Lead routine sample testing activities and ensure timely turnaround
- Author and review study protocols, characterization reports, development reports, qualification protocol/reports and SOPs
- Present results to colleagues, management, and external partners when necessary
- Ensure all experimental procedures and documentation are compliant with highest quality and regulatory standards
- Develop work plans and prioritize work according to program needs to make sure timelines are met
- Identify and incorporate new state-of-the-art analytical techniques
- May supervise junior scientist(s)
- PhD or Masters degree with 3+ years post-graduate experience in virology, molecular biology, biochemistry, or analytical chemistry. Strong laboratory skill is a must. 2+ years of experience working in biopharmaceutical or CDMO is preferred
- The ideal candidate will have relevant knowledge and industrial experience in the field of analytical development for characterization and QC release of AAV gene therapy vectors or other relevant biologics. Thorough understanding of ICH and FDA guidelines is expected. Experience in qualifying and validating test methods in support of clinical or commercial manufacture is preferred
- The incumbent is expected to be proficient in sample preparation, data analysis, and operating/troubleshooting bioassay and cell-based assays using most of the following techniques: ELISA, qPCR, digital droplet PCR, Western blotting, mammalian cell culture/transfection, small animals/tissue sample handling, and FACS. Experience with lab automation will be a strong plus
- The incumbent should be a detail-oriented self-starter and be able to work independently under minimum supervision and effectively communicate results/conclusions to peers and management.
- The qualified candidate must be able to effectively partner with diverse team members from various functions
- Level will be commensurate with experience