Data Process Engineer, Process Development & MSAT

Poseida Therapeutics

Cell and Gene Therapy Biotech

Position Summary

Poseida is seeking a highly motivated and talented Process Engineer with focus on data analysis and trending applied to manufacturing to join the Manufacturing Science and Technology (MSAT) team in the Process Development department.  Ideal candidate will have a strong background in manufacturing and data analytics applied to cell culture and biopharmaceutical process.  As a Data Process Engineer, you will provide leadership for projects and activities aimed at increasing understanding of manufacturing processes through data trending, investigation, and sound data analysis for both autologous and allogeneic CAR-T products for cancer treatment. Additionally, you will evaluate new software and streamline procedures for data analysis and trending in support of external and internal manufacturing facilities. The ideal candidate will have a demonstrated knowledge of data analytics applied to GMP procedures for cell therapy/ biologics.




These may include but are not limited to:

·       Provide leadership to MFG data analysis team

·       Own systems and templates for data analysis and trending with the scope of increasing understanding of manufacturing process and manufacturing operations

·       Review and evaluate software for data monitoring, trending and tracking

·       Author and review technical documentation in support of MFG (BR, CAPAs, CCR, Risk Assessments, Gap Assessments, Reports, Protocols, etc.)

·       Drive Investigations and Root Cause Analyses

·       Analyze manufacturing data and support troubleshooting and conduct routine process monitoring

·       Improve business process for tech transfer, data review, and decision making

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

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

·       Other duties as assigned


Requirements, Knowledge, Skills and Abilities

·       Bachelors Degree in Chemical Engineering/ Data Science or related field with 5 plus years of biopharma experience (an equivalent combination of education and experience may be considered)

·       Strong understanding of GMP working environment

·       Proficiency with JMP statistical analysis software is a must have

·       Previous experience with multivariate analysis is desired

·       Hands on experience with leading Investigations/ Root Cause Analysis is needed

·       Demonstrated ability to take data science initiatives from ideation/proof-of-concept to implementation as it applies to biopharmaceutical manufacturing

·       Knowledge of machine learning techniques and other programming languages is a plus

·       Knowledge of big data and cloud technologies for cell therapy application (Tableau, Skyland, SIMCA, etc.) is desired

·       Strong problem-solving skills, capable of working in a fact paced environment with different priorities

·       Ability to interact and influence within and across diverse teams

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

·       Excellent organizational skills and an ability to prioritize effectively to deliver results within established timelines

·       Previous team leadership experience as well as project management is highly desired

·       Strong interpersonal skills including verbal and written communication are essential


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