We're seeking an experienced Team Leader to head our batch record review team at the Cell & Gene Manufacturing facility in Maryland. Experience in Cell & Gene Therapy. Oversee the review of batch records for completeness and compliance with SOPs, GMP guidelines, and regulatory requirements.

They will also generate mutants using CRISPR and analyze changes in gene expression. This individual will set up and perform experiments studying gene regulation in the fly retina. Previous experience with molecular biology, fly genetics, cell culture and/or DNA/protein molecular biology software is strongly preferred.

Demonstrates the ability to follow established procedures according to Good Manufacturing Practices (GMP) Responsible for validating processes and equipment that are directly related to filtration, cleaning and sterilization.

Experience in GMP regulated environment. Verifying system drawings including ability to review and as built P&IDs (piping and instrumentation drawings) and I&C (instrumentation and controls) drawings as well as verifying electrical schematics with support of an electrical engineer.

Works within standards and operating procedures to plan, perform, and make decisions regarding the set up and operations of a variety of production equipment, including automated machine processes and controls to perform routine assembly-line production functions of filling, packing, assembling, labeling and inspecting.

Experience within cell and gene therapy strongly preferred. Help build the mRNA and Cell Therapy sales process and record information in Salesforce (SFDC) database to enable both peers and commercial leadership across the greater Thermo Fisher network to communicate and succeed.

Complete service documentation, as required, by the position function or requested by System Support Engineering Manager in accordance with current GMP requirements. Install and service instrumentation with minimum direct supervision, as requested, by the Service Center in accordance with current ISO (International Organization for Standardization) and GMP (Good Manufacturing Practices) standards.

Provides support to the lead/supervisor when necessary. Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantities. Responsible for the removal and disposal of waste chemicals, solvents and acids.

A minimum of 3 years experience working in an Aseptic Production environment, Experience working in a GMP-regulated environment preferred. Daily inspection of GMP logbooks. Quality System Management includes but is not limited to CAPA Investigations/LIRs and Internal Audit Observations.

The QC Analyst will be supporting microbiology, environmental monitoring (EM) and utility testing programs for a GMP facility. Perform environmental monitoring and utility testing of the GMP facility.

Knowledge of GMP and ISO requirements. Position : Procurement Coordinator. Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only) Knowledge of Lean and/or Six Sigma. Action oriented, dependable with excellent attention to detail and follow-up skills.

Food manufacturing GMP experience preferred. Diagnoses and repairs gearboxes, bearings, pumps and other mechanical and hydraulic systems. Troubleshoots discrete and analog sensors including pressure, temperature, flow, photo-electric, and inductive proximity, as well as PLCs and pLC controlled systems and machines.

They will need to have at least 1-2 years’ experience in a laboratory setting, familiar with GMP and able to follow all procedures in the making of panels for the assembly side of the business.

Cell/Gene Therapy experience preferred. Cell/Gene Therapy experience preferred. The Investigators in this role will be responsible for executing root cause investigations, owning/authoring deviations, driving continuous improvement efforts, and overseeing CAPA's.

Follow all safety guidelines and Good Manufacturing Practices (GMP) within the food and spices production and packaging area. TBest Services, Inc. is seeking Food Packaging Line Workers to join our client's expanding team in Hunt Valley, MD.