Biopharmaceutical Manufacturing Associate

This individual will be a team member in a cGMP regulated biologics manufacturing environment producing HIV-1 and MS therapeutic vaccines currently in later stage clinical trials. Additionally, the individual will cross train and contribute to the development, optimization and scale up of the cell culture, isolation, purification, and downstream aseptic processing operations. Specific GMP manufacturing processes include extensive downstream aseptic processing of vaccine antigens to produce multiple drug products. Originates, revises and reviews documentation to support manufacturing, process optimization, and process validation. Perform lab scale and scale up experiments. Assists in trouble shooting and modification of bio-manufacturing processes. Performs routine maintenance and troubleshooting of production areas and equipment. Equipment preparation including washing, assembly, sterilization and decontamination. Participates in audits and investigations and implements solutions to resolve problems. The incumbent will be responsible for adhering to all corporate and facility safety guidelines and procedures.
REQUIREMENTS
Bachelors Degree in Life Science or Engineering (Chemical preferred) with 3 to 5 years experience in Biopharmaceutical manufacturing, aseptic processing, and/or process optimization. Technical experience with one or more of the following: cGMP aseptic processing, cell culture, protein purification techniques, and hands on experience with formulation/filling of injectible products, process chromatography, ultrafiltration and dead end filtration. Experience with documentation, general procedures and operation of process equipment in a GMP production facility required. Experience with the following a plus: Bioanalytical/Immunoassay techniques, Mammalian cell culture, Bench/pilot scale biochromatography, Aseptic small volume syringe filling procedures. Significant previous experience following NIH/CDC Biosafety guidelines and working with retroviral and/or other bio-hazardous agents preferred. Experience with factory acceptance testing, installation, commissioning and IQ/OQ/PQ of equipment a plus. Must be detail orientated with the proven ability to work in a small multi-disciplinary team environment as well as independently under general supervision. Effective verbal and written communicator. Computer literate with working knowledge of MS Word, Excel and Power Point.