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Process Development Specialist

Zoek Pin Stanford, CA


Permanent (Full time)

Process Development Specialist ð??School of Medicine, Stanford, California, United States New Research ???6 days ago Post Date ???86775 Requisition Process Development Specialist Grade:GFTE:100% TheStanford Center for Cancer Cell Therapy (CCT) is seeking a Process DevelopmentSpecialist (PDM2) to independentlyconduct major portions of complex process development, with the intention totech transfer to our manufacturing team for clinical trial production, consistentwith principles of current Good Manufacturing Practice (cGMP) and aligned withthe clinical trial investigational phase for treating patients with incurablediseases. This recruitment is for up toone (1) full time position. ProcessDevelopment Duties include: Lead CCT (Center for Cancer CellTherapy) PD biomanufacturing campaigns primarily as a main operator. Prepareexperimental plans with necessary reagents, timelines, provide scientifichypotheses and experimental rationale. Mainly focused on CART and TCR based therapies. Coordinate PD activities with allnecessary functional teams: operations, quality systems, regulatory affairs,and business & administration. Train on biomanufacturingprocedures, Batch Records, or provide direction during process development activities. Plan and perform complex componentsof process development for technology transfer, scale-up/scale-out,optimization activities and characterization of new, state-of-the-arttechnologies in transition and translating pre-clinical, benchtop research intophase appropriate clinical trials. This includes testing and processoptimization of closed-system cell manufacturing platforms and novel geneediting technologies. Perform detailed analysis ofexperiments and compilation of data using GraphPad/Prism, FlowJo/Cytobank,Excel, RStudio, etc. Plan and perform upstreamcomponents of assigned cGMP projects. Identify strategies for innovationin production systems and manufacturing processes. Identify areas for cultureoptimization and common manufacturing deficiencies or gaps, to address withprocess improvements. Develop process development budgetincluding sourcing, identifying and ensuring qualified and verified rawmaterials for scale up PD runs; outline overall and per/PD run costs forproject materials and supplies and hours dedicated to complete all steps per PDrun. Determine need for, devise, andrevise Standard Operating Procedures and Batch Records for tech transfer to CCTcGMP manufacturing team. May be asked to occasionallysupport clinical manufacturing efforts in the GMP clean rooms, and will have tocomplete required cGMP trainings Participate in discussions withinternal and external collaborators, providing analyzed data and review whenappropriate Prepare and submit abstracts for publication in peer-reviewedjournals and/or presentation at scientific conferences. The Center for Cancer Cell Therapy is a part ofthe Stanford Cancer Institute (SCI), which is one of an elite number ofNational Cancer Institute-Designated Comprehensive Cancer Centers in thecountry, and is a prominent, dynamic, growing and complex Institute within theStanford University School of Medicine. The SCI actively works to buildsynergies and collaborations among faculty with cancer-relevant expertise fromfour Schools and over 30 departments across Stanford University. - Other dutiesmay also be assignedDESIREDQUALIFICATIONS: Bachelor's degree in chemistry, microbiology, biological sciences etc. Experience with CAR T, TCR, Tcells, gene editing, and cell and gene therapy processdevelopment/manufacturing desired. Aseptic technique and cell culture experience is preferred cGMP experience is preferred Knowledge of and experience generating SOPs, batch records, and other documentation for tech transfer into cGMP preferred Experience with tech transfer, engineering/qualification runs a plus. Experience with following assays desired: cell culture, ELISA, tumor-killing assays, flow cytometry/CyTOF/FACS, qPCR/PCR, gene editing/CRISPR Experience with the following software a plus: Prism/GraphPad, FlowJo/Cytobank, Microsoft Word/Excel/Powerpoint, a plus: SnapGene, DOE Software/ JMP, EDUCATION & EXPERIENCE(REQUIRED):*Bachelor's degree in related scientific field and two years ofrelated experience, or Master’s degree, or an equivalent combination ofeducation and relevant work experience. *KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): Strong biological scientificbackground Working experience with asepticcell culture Understanding of cGMP requirementsor needs Strong computer skills and abilityto learn quickly and master computer programs, databases and scientificapplications Ability to work under deadlineswith minimal supervision Ability to maintain relationships andcommunicate effectively Excellent organizational skills anddemonstrated ability to complete detailed work. PHYSICALREQUIREMENTS: Frequently sit, grasp lightly, use fine handmanipulation, repetitive pipetting, perform desk-based computer tasks, andlift, carry, push, and pull objects up to 15 pounds- Consistentwith its obligations under the law, the University will provide reasonableaccommodation to any employee with a disability who requires accommodation toperform the essential functions of his or her job. WORKINGCONDITIONS:* May require working in closeproximity to blood borne pathogens. Ability to work under deadlines andmeet/ exceed unpredictable manufacturing schedules. Position may at times require theemployee to work with or be in areas where hazardous materials and/orinfectious diseases are present. Position requires working in a cGMPclean room environment. Position may work with viruses:lentiviruses, adeno-associated viruses, and/or retroviruses. Position may work with cancer celllines or human embryonic stem cells (hESCs). Employee must perform tasks thatrequire the use of personal protective equipment, such as safety glasses andshoes, protective clothing and gloves, and possibly a respirator. May be exposed to high voltageelectricity, radiation or electromagnetic fields, lasers, noise > 80dB TWAAllergens/Biohazards/ Chemicals, and confined spaces, working at heights. May require extended or unusualwork hours based on process development requirements and business needs. May berequired to stay at work until product is harvested. WORK STANDARDS: InterpersonalSkills: Demonstrates the ability to work well with Stanford colleagues andclients and with external organizations. Promote Culture ofSafety: Demonstrates commitment to personal responsibility and value for safety;communicates safety concerns; uses and promotes safe behaviors bases ontraining and lessons learned. Subject to and expected to comply with all applicable Universitypolicies and procedures, including but not limited to the personnel policiesand other policies found in the University’s Administrative Guide, .edu. (.edu/)Additional Information Schedule: Full-time Job Code: 4928 Employee Status: Regular Grade: G Department URL: .edu/ (.edu/) Requisition ID: 86775

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