Job Description:

This is an exciting opportunity to join a Cell & Gene Therapy company revolutionizing cancer immunotherapies! You'll be responsible for ensuring the highest standards of Quality Control Microbiology for life-saving therapies. You'll be responsible for supporting the ramp up of new QC labs, performing key QC lab techniques including ELISA assays and flow cytometry platforms. You'll also be charged with mentoring fellow QC team members, performing GMP Quality investigations and QC stability testing. Your roles and responsibilities will include: * Leading and performing hands-on laboratory techniques including ELISA assays as well as immunoassays or cell-based potency assays.* Performing and working with flow cytometry and cell counting platforms. * Leading and supporting the generation and revision of laboratory documentation including CAPA's, Change Controls, SOP's, protocols, deviations and laboratory investigations. * Mentoring and training laboratory colleagues and team members.* Leading and performing GMP investigations for OOS test results and other Quality related events and implementing corrective actions.* Providing vital support to QC product stability programs, including protocol generation, execution of QC stability testing and QC stability data analysis.* Performing QC laboratory testing within GMP and GDP compliance.* Conducting timely trend analysis and generating reports for data analysis.* Thriving in a fast-paced environment, consistently delivering high-quality and accurate results with minimal supervision. Desired Skills & Experience * BS degree in Biology, Chemistry, Biochemistry, Microbiology, Molecular Biology or Life Sciences field.* 5+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.* Hands-on experience working with ELISA assays as well as immunoassays or cell-based potency assays.Hands-on experience working with flow cytometry and cell counting platforms such as FACS. * Expertise leading or performing QC investigations with successful experience resolving related deviations.* Experience ensuring GMP compliance, providing GMP documentation and regulatory inspection readiness. Additional Position Requirements: * Must be able to wear appropriate lab and clean room PPE including gowning coveralls, masks and gloves.* This is a full-time permanent position working on either a Sunday through Thursday or Tuesday through Saturday schedule. Company Description This is an exciting new opportunity within an expanding US BioPharma company developing and commercializing novel late-stage cancer Immunotherapies and Cell Therapies. This is a full-time permanent growth position offering a competitive Base Salary, target bonus and excellent healthcare benefits.