|Title:||Scientist/ Sr Scientist/ Process Engineer- AAV Purification|
We are seeking a collaborative and highly technically motivated Scientist with protein purification and/or AAV vector purification experience. This position is hands-on and a potential leadership opportunity. The individual will be responsible for chromatography and filtration based bioseparations activities associated with the conceptualization and development of downstream AAV purification operations in manufacturing processes for sterile injectable AAV-based gene therapy drug products.
The scope includes all aspects of downstream process development efforts with focus on the manufacturing of AAV-based gene therapies including scientific principles and underlying concepts and methodology of biomolecules, proteins separations using affinity chromatography, ion-exchange chromatography, tangential flow filtration (TFF) and viral vector separation, purification and enrichment of full capsids.
- Solid working knowledge of basic chromatographic separation techniques and routine analytical procedures for characterization of process intermediates
- Design and conduct small-scale cell experiments with AKTA systems including scale-down model supporting production-scale purification optimization
- Develop and conduct experimental approaches including design of experiments (DOEs) to chromatography conditions
- Support and assist in technology transfer activities and oversight at CDMOs/CROs;
- 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
- 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).