Stanford Laboratory for Cell and Gene Medicine (LCGM) is seeking a Quality Control Specialist (100% FTE) to design, develop, evaluate and implement quality control testing, assays and procedures for clinical materials manufacturing consistent with principles of current Good Manufacturing Practice (cGMP) to support phase appropriate clinical investigation(s) for treating patients with incurable diseases.
LCGM is a GMP multi-product biologics manufacturing facility that provides regulatory, quality systems, process development and manufacturing support to the School of Medicine, Lucile Packard Children's Hospital (LPCH) and Stanford Health Care (SHC) in developing innovative cell and gene-based therapies for the treatment of disease and the promotion of health in pediatric and adult patients in Phase I/II clinical trials.
LCGM is a growing, dynamic team who are dedicated to supporting translational medicine and contributing to Stanford Medicine's mission. We invite you to join our team!
Evaluate, develop and perform complex chemical, biochemical, biological and/or microbiological testing, assays and procedures related to quality control (QC), which constitute the quality, safety and efficacy of all analytical methods for clinical materials manufactured at Laboratory for Cell and Gene Medicine (LCGM).
Develop and perform tests related to assays/analytical methods; collect, interpret, analyze and report data related to test results including investigation of out-of-specification and/or non-conforming test results.
Perform analytical method, analyze collected data, and determine specifications for each test method. Evaluate proposed specification changes and escalate to Functional Manager. Present data to stakeholders (PIs, LCGM team, clinical team).
Perform and document assay qualification as applicable per regulation requirements. Document execution of test methods according to test procedure, GMP, and good documentation requirements. Manage materials/supplies related to clinical materials manufacturing. Create selection criteria, justification and qualification of raw materials as it relates to assay development. Responsible for examining and documenting materials used in clinical materials quality control testing, consistent with defined, relevant quality standards and cGMP.
Participate in the evaluation of suppliers/contract testing lab including, but not limited to, analyzing test methods and establishing contract with supplier/vendor as applicable. Resolve issues associated with vendor/supplier and changes/deviations to the generation of materials/reagent.
Ensure equipment qualification, preventive maintenance, and calibration are performed per requirement and by due date. Coordinate equipment implementation for use and decommissioning activities.
Investigate out-of-specification and/or non-conforming test results. Initiate, investigate as appropriate, and prepare deviation reports for SOPs and test methods with input from supervisor in order to implement prevention or corrective actions.
Perform QC Support tasks e.g. equipment maintenance, tracking of reagent and sample inventory, organization of the lab, checking to ensure removal of expired media performed, etc.
Coordinate the timely shipment of samples to contract laboratory for testing (e.g. ship samples such as environmental monitoring plates for growth promotion, speciation and product sample).
Ability to effectively work in fast pace environment with cross functional groups involved in multiple projects and timelines.
Flexibility to support changing priorities while maintaining collaborative approach and cGMP compliance.
Able to work independently with some supervision, propose recommendations and solutions regarding development and execution of QC assays.
3-5 years cGMP experience.
Experience with Cell Culture activities, Flow Cytometry, qPCR, Sterility testing, and/or Environmental Monitoring activities.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in relevant scientific discipline or other appropriate specialty (such as Chemistry, Life Sciences, Biochemical Engineering, or Engineering) and three years' experience or an equivalent combination of education and relevant work experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Applicable or related experience in clinical laboratory, hematology, blood banking, immunology or QC laboratory preferably in cGMP environment.
Strong analytical technical skills and experience with testing QC methods and concepts.
Good understanding of cGMP or International Organization for Standardization (ISO) requirements, quality systems.
Strong team-oriented, interpersonal skills and collaborative work style.
Ability to manage and coordinate all tasks assigned and effectively complete all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.
Excellent organizational skills and attention to detail.
Excellent verbal and written communication skills.
CERTIFICATIONS & LICENSES:
May require working in close proximity to blood borne pathogens.
Position may at times require the employee to work with or be in areas where hazardous materials and/or infectious diseases are present.
Employee must perform tasks that require the use of personal protective equipment, such as safety glasses and shoes, protective clothing and gloves, and possibly a respirator.
May be exposed to high voltage electricity, radiation or electromagnetic fields, lasers, noise > 80dB TWA, Allergens/Biohazards/Chemicals, confined spaces, working at heights
May require extended or unusual work hours (including weekends) based on research requirements and business needs.