Manufacturing GMP-grade cellular and gene therapy products, following established processes, SOPs, and master batch manufacturing records (includes processing blood, bone marrow, and other cell samples, isolating specific cell populations, preserving samples, and distributing them to appropriate testing laboratories.
Performing analyses (such as cell counting, viability determination, mycoplasma assay, endotoxin assay, progenitor cell CFU assays, PCR assays, and potency testing) of clinical samples, verifying results and monitoring for completeness, accuracy, clinical validity, legibility, documentation, and transcription errors.
Performing quality control during manufacturing, reviewing, and verifying the work of others as assigned.
Maintaining records of patient sample and investigational agent storage, applying appropriate labels to incoming and outgoing products, and monitoring product labels and handling during manufacturing.
Maintaining cell-processing rooms in accordance with SOPs, including cleaning, environmental monitoring, and stocking reagents and materials.
Coordinating with physicians and support staff for the collection of cells from study participants.
Receiving and storing cellular therapy products from external sponsors, processing these and other cell therapy products for administration to patients and maintaining logs and proper storage of these products and retained samples.
Validating new test methods introduced into the laboratory.
Training new and other personnel in the facility.
Generating batch records, chain of custody forms, certificates of analysis, and other records, maintaining complete documentation.
Obtaining and maintaining all necessary training for work with human samples, including Biosafety, HIPPA, IRB certification, and GMP-specific training.
Maintaining complete documentation as required by Federal law.
Ordering, receiving, storing, performing quality control, documenting, maintaining, and inventorying materials and reagents.
Developing protocols, worksheets, SOPs, and master batch manufacturing records as needed for specific product manufacturing and operations.
Performing environmental monitoring of the GMP Facility per established SOPs.
Acting as a technical consultant to clinicians, colleagues, and researchers.
Serving as a backup to the GMP Facility Manager for managing facility and equipment maintenance, CO2 and LN2 systems, biohazard waste disposal, and assisting with GMP-related training courses.
REQUIREMENTS
Minimum 2-5+ years of tissue culture experience.
Knowledge and practical experience in aseptic technique/tissue culture.
Understanding of GMP requirements and regulations, with previous experience directly involved with federal regulations regarding GLP or GMP.
Knowledge of SOPs and Quality Control requirements in a GMP laboratory setting.
Ability to work independently and closely follow SOPs.
Ability to wear protective clothing for extended periods.
Ability to work flexible hours and determine workload priorities to meet deadlines.
Strong interpersonal communication skills.
Excellent record-keeping skills and good documentation practice.
Demonstrated knowledge of FDA Good Laboratory Practice, Good Tissue Practice, and Good Manufacturing Practice guidelines.
Teamwork skills and ability to prioritize and demonstrate critical thinking.
Ability to work independently and collaboratively with multiple departments.
Ability to carry out analytical tasks, identify and define issues, resolve problems, and draw logical conclusions.
Ability to gather pertinent data, prepare reports, charts, graphs, and tables.
Ability to review documents, data, and material compiled by others for completeness and accuracy.
Ability to deal with and maintain confidential and sensitive information.
Strong decision-making skills and ability to take appropriate action in ambiguous situations.
Ability to work on multiple projects simultaneously and organize projects for efficiency.
Ability to attend off-site meetings and conferences.
Exceptional database and computing skills.
Excellent English-writing skills for composing, proofreading, and editing correspondence and reports.
Working knowledge of medical and scientific terminology.
Demonstrated skill in records management and utilizing computer software for data analysis and report preparation.
Ability to learn other software/systems as required.
EDUCATION
Bachelor of Science
Master of Science or Ph.D. Degree in Biology, Chemistry, or related field is a plus