Senior Scientist, Process Development & MSAT

Poseida Therapeutics

Cell and Gene Therapy Biotech

Position Summary

Poseida is seeking a highly motivated and talented individual to join the PD & Manufacturing Science and Technology (MSAT) team in the Process Development organization.  Ideal candidate will have a strong background in cell culture and biopharmaceutical process development from clinical to commercial stage.  As a Senior Scientist, you will provide leadership for projects and experimental activities aiming at improving and optimizing manufacturing processes for both autologous and allogeneic CAR-T product for cancer treatment. Additionally, you will evaluate new technologies and streamline manufacturing procedures in support of external and internal manufacturing facilities.The ideal candidate will have a demonstrated knowledge of phase appropriate process development as well as strong understanding of GMP environment for cell therapy/ biologics manufacturing.




These may include but are not limited to:

·       Provide leadership to design optimization studies to increase productivity, robustness, and/or yield of manufacturing operations while maintaining or improving product quality attributes

·       Author and review technical documentation to evaluate impact of process changes and support change controls initiative

·       Collaborate with R&D, manufacturing and quality teams to advance process improvements and support manufacturing process

·       Improve business process in support of tech transfer, process changes and decision making process

·       Lead projects, build timelines and provide readouts to senior management

·       Design and implement business process to decrease COGs and streamlining of manufacturing procedures

·       Author and review regulatory sections and dossiers as needed

·       Participate and influence a cross-functional development team to advance CMC activities

·       Present main findings to internal and external partners as well as major stakeholder within the company

·       Other duties as assigned



Requirements, Knowledge, Skills and Abilities

·       PhD in biotechnology/ chemical engineering with 5 plus years of process development experience (an equivalent combination of experience and education may be considered).

·       Technical understanding of cell processing technologies for cell and gene therapy

·       Proven track record with phase appropriate development process optimization

·       Experience with continuous manufacturing processes including operation in upstream genetic modification and bioreactor/WAVE expansion, as well as, formulation/fill finish and cryopreservation

·       Experience in media development, disposable processing technologies and automation of manufacturing processes

·       Experience in gene editing delivery technologies is preferred

·       Understanding of cGMP manufacturing and regulatory requirements for pharmaceuticals development is desired

·       Remains current with state of the art cell therapy techniques and trends in the industry

·       Understanding of statistical data analysis and process trending

·       Ability to work in a fast-paced, startup environment

·       Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously


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