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Quality Control Sr. Analyst - Cell Therapy

Company: ImmPACT Bio
Location: Camarillo
Posted on: May 7, 2022

Job Description:

Job DescriptionQuality Control Sr. Analyst - Cell TherapyImmPACT Bio is a clinical-stage company, headquartered in the Los Angeles area, and with a subsidiary in Israel, developing novel cell therapies for treating cancer. The company's next-generation chimeric antigen receptor (CAR)-T cell technologies are based on Boolean logic-gate approaches and address key biological challenges for engineered T cell therapies including relapse due to antigen loss/escape; on-target, off-tumor toxicities; and the immunosuppressive tumor microenvironment. ImmPACT's lead program, a bispecific "OR-gate" CAR, with an excellent tolerability profile, has demonstrated durable complete remission (CR) in 88% of patients treated so far. ImmPACT Bio provides a generous rewards package, with competitive compensation and health benefits, with career progression benefits as part of a rapidly growing multi-platform company. ImmPACT-Bio is seeking a QC Sr. Analyst to support routine QC activities in support of Clinical and future Commercial Manufacturing of the new GMP cell therapy production facility located in West Hills, CA. This individual will perform core laboratory testing including ELISA, Cell Culture/counting, Flow cytometry, PCR, and other related testing and will ensure GMP QC lab maintenance by managing or monitoring facilities, lab equipment, and reagents, etc. This individual will perform all activities in a cGMP environment by accurately following relevant SOPs, make and maintain accurate documentation, and monitor details and report any deviation to senior members or a manager as needed. This individual's duty is primarily internal and will interact with peers and leadership within QC as well as other cross functional team members from QA and Product Development. This full-time position reports to the Supervisor of Quality Control.Primary Responsibilities:

  • Performs QC analytical testing to support the in-process testing, release and stability of final products to support the release of products for clinical use, with consideration of compliance, quality and consistency
  • Maintains GMP laboratories by monitoring lab equipment and availability of lab supply
  • Manages GMP and non-GMP samples, order and receive lab reagents and materials, and manages the inventories
  • Performs all activities in accordance with cGMP requirements and reports abnormalities
  • Initiates and completes laboratory discrepancy events on time
  • Documents test results to ensure completeness and accuracy per cGMPs
  • Keeps accurate documentation and tracks records
  • Performs easy to moderate equipment troubleshooting. Performs laboratory maintenance and cleaning activities
  • Supports discrepancy investigations, laboratory investigation reports and implementation of corrective and preventative actions
  • Performs assay training and manages multiple tasks concurrently and effectively
  • Performs non-routine laboratory tasks
  • Contributes toward the development, revision, application, maintenance, validation and review of SOPs. Initiates and follows up on change request for SOP revision
  • Assists with addressing questions during regulatory compliance audits and supports inspection related needs as required
  • Maintains good interactions with peers, department management, and internal departments (QC, QA, Product Development) and supports positive employee relations climate.Qualifications:
    • B.S. degree in a scientific discipline with 3+ years of experiences in a cGMP compliant environment or equivalent combination of education and experience
    • Demonstrated knowledge and experience in "core" laboratory techniques (ELISA, Cell culture and Cell-based assay, PCR, Flow cytometry, etc.)
    • Previous working experience in aseptic techniques and/or in flow cytometry is a plus
    • Experience in maintenance of GMP laboratory equipment and supplies
    • Able to perform QC laboratory maintenance related duties as assigned
    • Experience in supporting OOS investigation and CAPA initiation is a plus
    • Working knowledge of SOP writing and SOP change request is a plus
    • Able to follow instructions and SOPs precisely and able to make/keep accurate documentation
    • Able to learn new skills rapidly and achieve proficiency
    • Detail-oriented with good written and verbal communication skills
    • Good organizational and planning skills, and an ability to work efficiently
    • Able to seek and accept input from more senior team members for the performance of assignments as needed
    • Ability to solve problems of minor to moderate level and troubleshoot as necessary
    • Team player with good interpersonal skillsImmPACT Bio USA, Inc., is a clinical-stage company dedicated to the discovery of transformative chimeric antigen receptor (CAR) T-cell therapies for cancer patients who have exhausted their treatment options. The company's logic-gate-based CAR T platforms address key biological challenges in treating cancer. ImmPACT Bio's technologies are specifically designed to prevent antigen escape, prevent ‘on-target – off-tumor' toxicities, and overcome the immunosuppressive tumor microenvironment.Powered by JazzHRJ8daCQ7PBu

Keywords: ImmPACT Bio, Camarillo , Quality Control Sr. Analyst - Cell Therapy, Healthcare , Camarillo, California

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