|Title:||Senior Scientist/ Principal Scientist, Cell Culture Development – AAV Gene Therapy|
We are seeking a collaborative and highly technically motivated Scientist with multi-disciplinary cell line and cell culture processing development expertise to join our process development group. This position is hands-on and a potential leadership opportunity. The individual will be responsible for mammalian cell culture activities associated with the conceptualization and development of upstream cell culture operations in manufacturing processes for sterile injectable AAV-based gene therapy drug products.
The scope includes all aspects of upstream process development efforts with focus on the manufacturing of AAV-based gene therapies including scientific principles and underlying concepts and methodology of mammalian cell culture (adherent and suspension), transient transduction, viral vector expression and isolation.
- Have solid working knowledge of basic cell culture laboratory techniques, aseptic expansion of mammalian cell culture and routine analytical procedures for characterization of cell culture parameters in general (cell growth rate, cell density, viability, population doubling and overall cellular metabolic activity)
- Design and conduct small-scale cell culture experiments including scale-down bioreactor to develop and validate scale-down process model supporting production-scale bioreactor optimization
- Develop and conduct experimental approaches including design of experiments (DOEs) to media optimization, pre-culture conditions, seed train strategy and critical process parameters (CPPs) and key performance indicators (KPIs) of the production bioreactor in the development and confirmation of upstream process operations for new products
- Collaborate with other functional groups including cell-line and analytical development teams for screening and characterization studies; familiarity with titer assay development including primer design, DNA isolation/purification and PCR quantification using data analysis packages highly desirable
- Support and assist in technology transfer activities and oversight at CDMOs/CROs
- Overall and importantly, as part of the Upstream Team you will: (i) contribute to Team efforts to apply engineering control concepts to efficient process attribute screening, optimization and scale-up of mammalian cell culture systems; (ii) establish robust, scalable, and productive upstream cell culture processes; and (iii) establishment of platform-based expression and isolation operations for AAV-based vector therapeutics.
- Author, review and provide technical support to the establishment and continuous improvement of manufacturing SOPs and batch production records
- Mentor associate scientists and research associates
- PhD in chemical or biochemical engineering or related life sciences and 5+ years of work experience in a research and/or development environment
- Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered (7-10 years)
- Knowledge in broader scientific principles and underlying concepts of cell culture including cell line development and upstream process development for gene therapy or viral vaccine drug candidates, both internally (pilot plant) and externally (CDMOs) highly desirable
- Demonstrated success and accomplishment in scientific creativity; sound judgment and problem-solving capabilities
- Ability to collaborate with others while maintaining a strong capability in independent, critical thought
- Must be able to clearly communicate scientific information in both written and oral settings
- Strong organizational skills are required and must be able to work as part of a team
- Experience working in an FDA regulated environment and knowledge of current GMPs as they apply to quality control laboratory practices are highly desired
- Ability to travel (10% travel time).