Job Description

Senior Scientist, Analytical Development

Kodo Lifescience (KLS) is a supplier of high quality biological raw materials. We optimize methods for the cost-efficient manufacturing of these raw materials to enable the development of accessible cell and gene therapies worldwide. We are looking to add a highly motivated scientist at our Chennai R&D lab in a lab based role to help develop analytical methods for supporting our manufacturing process development efforts, developing in process tests to establish process control limits and impurity profiles as well as establish release tests for the final products that we manufacture. The candidate will work on the development, qualification, and transfer of the methods developed into our GMP manufacturing facility. Please reach out to srinivas.rengarajan@kodolifescience.com with your resume and cover letter

Job Responsibilities
1)   Develop viral vector quantitation and characterization assays to support the development of viral vector manufacturing upstream and downstream processes with accurate mass balance calculations
2)   Develop in-process methods to characterize the virus production processes, determine control limits for process control
3)   Develop and qualify release tests for viral vector products that Kodo plans to produce
4)   Manage outsourcing of certain tests by identifying suitable vendors, be the primary technical liaison with vendor to complete the required testing
5)   Transfer the methods developed to the QC lab in the Kodo GMP manufacturing facility as needed (travel to GMP facility as needed)
6)   Develop/improve assays to characterize manufacturing processes and final products such as plasmid DNA and associated molecules
7)   Perform release assays for GMP-lite plasmids made in the Chennai facility in collaboration with QC/QA
8)   Author method development summaries, maintain excellent lab records, mentor and train other analytical development staff

Prior experience and skills preferred
1)   BSL2+ cell culture and aseptic technique. Developed and performed cell-based assays in this environment
2)   Lentiviral characterization assay development experience – titration by p24 ELISA, flow cytometry (immunostaining or fluorescent protein), viral copy number, analytical HPLC
3)   Molecular biology methods for characterizing plasmid DNA/mRNA including but not limited to AGE, restriction digestion, analytical HPLC, impurities quantification (endotoxin, antibiotics, HCP, HCDNA) by plate-based methods
4)   Knowledge of regulatory requirements and product specifications of viral vectors and plasmid DNA is a big plus
5)   Good to have experience developing, qualifying, tech transferring assays from a R&D environment to a QC environment
6)   Data analysis and presentation skills, strong communication, excellent recordkeeping and attention to detail
7)   MSc (related field) and 6+ years of experience or PhD and 4+ years of experience is preferred