To produce veterinary biologics according to a defined production schedule following cGMP guidelines and specific outlines of production to meet market demands for Aquaculture products.
Comply with safety requirements, cGMP, SOP and manufacturing documentation Produce veterinary biologics according their approved Outline of Product/Product Dossiers and to cGMP guidelines in order to meet market demand for the Aqua products
Perform biologics recovery and purifications using process scale TFF unit, columns and chromatography system
Operate and maintain production instruments and equipment, such as pH Meters, Conductivity meters, spectrophotometer, TFF equipment, Peristaltic pumps , rotary pumps , chromatography systems/
Perform column packing using packing skids, process analysis using spectrophotometer, integrity testing on various types of filters
Write and review batch records, SOPs, qualification documents for the downstream operations
Use SAP system for material consumption in production
Collaborate with other departments involved in GMP manufacturing for planning production, testing and product release in a timely manner resulting in successful completion of projects
Work closely on technology transfer project from Process Development to Manufacturing
Work with the upstream manufacturing group to provide resources
Perform tasks under minimal supervision, and within tight time lines to meet production schedules
Troubleshoot TFF and chromatography operations
Assist in the maintenance of production equipment in good condition as per manufacturer’s specifications
Maintain cleanliness of the production areas and assist in disinfection procedures, clean and sterilize items used in purifications
Effectively investigate the events that happen during any batch failures using root cause analysis tools
Provide leadership to peers on the floor by demonstrating knowledge, expertise and implementing process improvements
Bachelor’s or Master’s Degree in a life sciences (e.g. Biochemistry, Chemistry, Chemical Engineering, biochemical engineering, Biology)
3-5 years of experience in the GMP bio manufacturing industry
3-5 years of experience in purification of biologics using large scale TFF filtration and chromatography processes
Experience performing investigations and writing deviations
Intermediate/Expert computer skills using MS Office (Word, Excel, Power Point), SAP and experience in Unicorn software is required
Excellent interpersonal skills, both communications and written. The candidate in this position must be able to communicate effectively with Management and staff.
Thorough technical understanding of quality systems and regulatory requirements
Must be able to work shift work (12 hour daytime shifts, 3-4 days/week including some weekends) and overtime as required
Required to assist in disinfection procedures involving hazardous chemicals requiring the use of a respirator.
Must be able to lift, move and maneuver small-medium sized equipment – up to 25lbs.
Requires ability to stand for long periods of time
Requires frequent ladder or stair climbing
Must be able to read, write, understand, and comply with appropriate standard operating procedures.