Scientist, In Process Testing
Job duties include for the Scientist in the In-Process Testing (IPT) Group, include, but are not limited to in-process testing for Process Development runs, testing of upstream and downstream samples, evaluating novel equipment, and performing a range of additional varied work activities including:
- Tissue culture and maintenance of mammalian cell lines
- Leading in writing and reviewing R&D and PD protocols, PDPRs, PDTRs, methods, SOPs, analyzing results, and drafting reports in support of R&D and PD processes and analytics.
- Leading teams tasked with in-process testing
- Performing in-process testing
- Training of new employees
- Communication with clients
- Serving as the lead for testing for various programs and projects
- Assist and lead Lab Technicians in organizing daily activities
- General molecular biology methods associated with cloning, PCR, gel electrophoresis, viral assays, protein analytical assays, and virus/vector propagation
- Performing and leading analysis of media, culture, and products
- Hands-on lab work associated with adherent or suspension cell culture, medium/buffer preparation, and cleaning/decontaminating of biosafety cabinets and incubators
- Play a significant role in research, product, and process development for both current and novel products
- Perform work in a BSL-1, -2, or -3 environment
- Organize and manage laboratory inventory including procurement of supplies and materials needed for protocol execution
- Initiation of investigations and implementation of resulting corrective actions into existing procedures
- Lead and organize training of Quality Control personnel prior to and during assay transfer
- Maintain PD inventory supply and ordering
- Work as a team with assay development, process development, QC, manufacturing, QA, and other departments as needed
- Contribute to the maintenance of laboratory equipment and laboratory support operations
- Analyze assay results and monitor trending data to inform PD runs
- All other tasks as needed or assigned by supervisor
Requirements
- PhD degree in molecular biology, biochemistry, chemistry, or related field
- BA or BS degree in molecular biology, biochemistry, chemistry, or related field plus 5 years of experience
- MS degree in molecular biology, biochemistry, chemistry, or related field plus 3 years of experience
- 2 years of cell culture experience, using aseptic techniques
Experience performing and developing analytical assays, including
- ddPCR and/or qPCR
- ELISA techniques
- TCID50, IU Titer, Plaque assays
- Residual host cell DNA and residual host cell protein
- Western blots, SDS-PAGE, Alkaline gel electrophoresis
- HPLC
- Experience with data analysis and data management
- Strong leadership, technical, communication, and organization skills in a teamwork environment
- Strong verbal/written and interpersonal communication skills as a team player and willing to work in an environment where individual initiative, collaboration, and accountability are valued
- Ability to work weekends independently with minimal supervision in an organized manner