MSAT Associate 2
Scorpion Therapeutics, Rancho Santa Fe, CA, United States
Responsibilities
Providingsupportto MSAT Teamand working cross-functionallytoensure clear communicationacross various departments. Management of deviations and other quality records, performingroot causeinvestigations(6M, 5-Why’s,etc)todeterminecausal factorsandevaluateproduct impact. Trainingonthe celltherapy and/orexosome platformsquickly toassistinproduct impactassessments, andcompilingscientific data relatingtothemanufacturing processes. Assistingwithtech transfers intocGMP Manufacturing,ensuringthe transfer iscontrolled and executed within GMP regulatory guidelines. Supporting Manufacturing group and troubleshooting production activities to ensure safe, quality, andtimelymanufacture of biopharmaceuticalproductfor pre-clinical,clinicaland commercial use. Assistingon revising(as needed) and reviewing process-related manufacturing documentation (batch records,SOPs, bills of material, process flow diagrams) toassureall clinical products meet the requirements for quality,safetyand efficacy. Providing in-person and real-time manufacturing production supportasneeded. Collaborating with Supplier Quality and Manufacturing to evaluate change notifications or material non-conformances. Identifyingcontinuousimprovement opportunities and/or corrective actions to increase yield, maximize capacity, improve operational efficiency, reduce costs, and ensure safety whilemaintainingregulatory compliance incross functionalcollaborations. Working closely withQualitydepartment to ensure compliance withcGMP,ICHand FDA regulations. Serving as an organizational change agent and fostering an atmosphere of a questioning attitude, empowerment, andan errorprevention/continuous improvement mindset. Performing such other duties as may be assigned to you from time to time. Requirements
Bachelor’s degreeand2+ years of hands-on cGMP biologics manufacturing experience in pharmaceutical/biotech industrypreferred, or equivalent combination of degree/experience. A minimum of 1yearexperience in adherent cell culture.Additionalexperiencewithcells in suspension is a plus. Experience with writing/revisingtechnical documentsisrequired(SOPs, Forms, Batch Records,etc). Previousexperience with,orknowledge/understandingof,variousquality eventsisrequired(Deviations, CAPAs, Change Controlsetc). Deep understanding ofcell culture and ability to troubleshoot commonprocessing issues. Experience with scale-up of cell therapy processesand closed manufacturing systems preferred. Ability to collect andassistin theanalyzation/trending ofdata and information todeterminepaths for process improvement and potential root cause. Demonstrates technicalproficiency, scientific creativity, problem-solving skills, strong GMPprinciplesand collaboration with others. Must have full working knowledge of cGMP regulations. Exceptional communication, presentation,and interpersonal skills. Strong Microsoft Word and Excel skills. Ability to work in a dynamic environment,multi-task,andmeet aggressive deadlines. Ability to work independently, as well as work on larger cross-department projectsas a team. Work Environment & Physical Demands
Professional GMP facility environment with controlled conditions. Ability to sit or stand for extended periods during training and operations. Occasional lifting of materials or equipment up to 40 pounds. Willingness to work inside an ISO7 cleanroom when supporting manufacturing operations. Compliance with gowning procedures and cleanroom protocols for aseptic activities.
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Providingsupportto MSAT Teamand working cross-functionallytoensure clear communicationacross various departments. Management of deviations and other quality records, performingroot causeinvestigations(6M, 5-Why’s,etc)todeterminecausal factorsandevaluateproduct impact. Trainingonthe celltherapy and/orexosome platformsquickly toassistinproduct impactassessments, andcompilingscientific data relatingtothemanufacturing processes. Assistingwithtech transfers intocGMP Manufacturing,ensuringthe transfer iscontrolled and executed within GMP regulatory guidelines. Supporting Manufacturing group and troubleshooting production activities to ensure safe, quality, andtimelymanufacture of biopharmaceuticalproductfor pre-clinical,clinicaland commercial use. Assistingon revising(as needed) and reviewing process-related manufacturing documentation (batch records,SOPs, bills of material, process flow diagrams) toassureall clinical products meet the requirements for quality,safetyand efficacy. Providing in-person and real-time manufacturing production supportasneeded. Collaborating with Supplier Quality and Manufacturing to evaluate change notifications or material non-conformances. Identifyingcontinuousimprovement opportunities and/or corrective actions to increase yield, maximize capacity, improve operational efficiency, reduce costs, and ensure safety whilemaintainingregulatory compliance incross functionalcollaborations. Working closely withQualitydepartment to ensure compliance withcGMP,ICHand FDA regulations. Serving as an organizational change agent and fostering an atmosphere of a questioning attitude, empowerment, andan errorprevention/continuous improvement mindset. Performing such other duties as may be assigned to you from time to time. Requirements
Bachelor’s degreeand2+ years of hands-on cGMP biologics manufacturing experience in pharmaceutical/biotech industrypreferred, or equivalent combination of degree/experience. A minimum of 1yearexperience in adherent cell culture.Additionalexperiencewithcells in suspension is a plus. Experience with writing/revisingtechnical documentsisrequired(SOPs, Forms, Batch Records,etc). Previousexperience with,orknowledge/understandingof,variousquality eventsisrequired(Deviations, CAPAs, Change Controlsetc). Deep understanding ofcell culture and ability to troubleshoot commonprocessing issues. Experience with scale-up of cell therapy processesand closed manufacturing systems preferred. Ability to collect andassistin theanalyzation/trending ofdata and information todeterminepaths for process improvement and potential root cause. Demonstrates technicalproficiency, scientific creativity, problem-solving skills, strong GMPprinciplesand collaboration with others. Must have full working knowledge of cGMP regulations. Exceptional communication, presentation,and interpersonal skills. Strong Microsoft Word and Excel skills. Ability to work in a dynamic environment,multi-task,andmeet aggressive deadlines. Ability to work independently, as well as work on larger cross-department projectsas a team. Work Environment & Physical Demands
Professional GMP facility environment with controlled conditions. Ability to sit or stand for extended periods during training and operations. Occasional lifting of materials or equipment up to 40 pounds. Willingness to work inside an ISO7 cleanroom when supporting manufacturing operations. Compliance with gowning procedures and cleanroom protocols for aseptic activities.
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