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Production Specialist - DSP

Production Specialist - DSP
Prince Edward Island
North America
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.