| Duties: | Perform process unit and support operations described in standard operating procedures (SOPs) and batch records including: PBMC, media and solution preparation; CAR-T cell drug substance preparation; and CAR-T drug product fill operationsAccurate and timely completion of documentation required by protocols, SOPs, and batch recordsMaintain aseptic technique during processing of products to ensure the integrity, viability and sterility of cell therapy products from PBMC thaw to final formulated drug product cryopreservationPerform tasks in a manner consistent with safety policies, quality systems, and cGMP requirementsTimely completion of training assignments to ensure the necessary technical skills and knowledge are applied compliantly during GMP operationsAssist in setting up manufacturing areas and equipment, including complex automated cell processing, cell expansion and filling equipmentUpdate and revise manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirementsRoutinely monitor, clean, prepare and operate processing and analytical equipment in Grade B/C areasFollow all cleaning and gowning procedures for the facilityPerform error free calculations of media component and cell concentration, dilution, viability during productionMust maintain and apply knowledge regarding donor information, screening and testing, labeling and product acceptability and release criteriaBe flexible and adaptable to schedule and procedural changes to ensure timely preparation of products with highest qualityMaintain current inventory of supplies kept in specified kitting and staging areas and CAR-T suites
Other duties as assigned | |
| Skills: | | Aseptic processing in Grade A biosafety cabinets and Grade B clean roomsCell culture processing experience in handling and propagation of human primary cells strongly preferredUniversal precautions for handling human derived materials in BSL-2 containment areasKnowledge of cGMP regulations and FDA guidance applicable to biologics and/or cell therapyExcellent interpersonal, oral and written communication skillsStrong technical writing ability strongly preferredAbility to work off-shift and long hours as requiredFrequent use of a computer monitor, keyboard and mouse requiredFrequent lifting, carrying, pushing or pulling up to 30 pounds requiredFrequent periods of sitting, walking, and standing requiredFrequent use of personal protective equipment requiredOccasional climbing stairs or ladders, bending or stooping, crouching or squatting requiredOccasional fine finger dexterity/ including grasping or pinching requiredOccasional use of hazardous materials and chemicals requiredOccasional work in cold rooms and freezers requiredColor, vision, and depth perception required for inspection or test related jobs.Candidates must be authorized to work in the U.S.Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.Ability to work independently and as part of a team.Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.Candidates must be authorized to work in the U.S. | |