Senior Scientist, Process Development with experience in Lentivirus, Extracellular Vesicle (EV), Exosomes or EV/Exosome-based therapeutics

***"Bridging innovation to cure"*** *Developing and Manufacturing your cell therapies from benchtop to bedside* # Job Summary Cellipont Bioservices is growing, and we are looking for a **Senior** **Scientist, Process Development** with experience in **Lentivirus,** E**xtracellular vesicle (EV), Exosomes or EV/Exosome-based therapeutics** who believes in the potential bridging clients discoveries to patient cures and who want to challenge the status quo and take Cellipont and it's clients to the next level. The **Senior Scientist, Process Development** will be part of the Process Development team and will participate in process development initiatives for our current and future therapy programs. This position plays a key role demonstrating the values, culture, and deliverables for the site. **The Role** - Design, optimize and perform experiments to optimize the processes for various therapy programs. - Design, optimize and perform mammalian cell culture processes using bench-scale to high-scale bioreactors. - Design, optimize and perform harvest and clarification strategies using depth filtration, tangential flow filtration (TFF), or centrifugation. - Design, optimize and perform purification workflows using chromatography (e.g., size-exclusion, ion-exchange, affinity) for isolation while removing host cell proteins (HCP) and DNA. - Design, optimize and perform ultrafiltration/diafiltration (UF/DF) parameters for final concentration and buffer exchange into stable formulations. - Perform cell isolation, modification, expansion, feeding and cryopreservation utilizing functionally closed systems. - Assist in process gap analysis and provide process development recommendations/plan to close the gaps. - Identify and implement appropriate equipment to develop highly robust and reproducible processes based on the cell type and unit operation. - Develop scale-up and scale-out of processes based on the cell type and application. - Coordinate with analytical development to test and characterize the product that is in development. - Lead and support discussions with clients for process development projects. - Prioritize the work to meet the timelines and deliverables. - Provide support to the Business Development team by attending the technical calls with prospective clients. - Assist in interaction with clients, key suppliers, and other external vendors. - Successfully execute and document laboratory procedures and experiments with great attention to detail. - Maintain detailed records in compliance with applicable cGMP, safety, and environmental requirements. - Develop internal documentation, protocols, and reports to support transfer of processes to Manufacturing group. - Perform data analysis and basic statistical analyses. - Monitor and perform lab preventive maintenance activities as needed. - Contribute at an individual level as well as part of an organized team in a fast-paced environment. - Performs other duties as assigned. **The Candidate** - Bachelors or Masters degree with 4-6 years minimum of industry experience - ***OR*** PhD with 1-2 years minimum of industry experience within pharmaceutical or biotech environment - Prior experience in Process Development for Cell and Gene Therapy is required. - Prior experience with Lentiviral or EV upstream processing, including hands-on experience with mammalian tissue culture including both adherent and suspension cells, and bioreactors (e.g., stirred-tank and rocking-motion). - Prior experience with Lentiviral or EV downstream processing, including purification unit operations such as preparative chromatography (affinity, ion-exchange), tangential flow filtration (TFF), and filtration. - Experience with Formulation & Concentration, including ultrafiltration/diafiltration (UF/DF) parameters for final EV concentration and buffer exchange into stable formulations. - Experience with common equipment used in lentivirus or EV therapy manufacturing such as Bioreactors, filtration, Tangenti…