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Biologics Production Specialist

2 months ago

Charlottetown, Prince Edward Island, Canada Elanco Full time
Job Summary

We are seeking a highly skilled and detail-oriented Biologics Production Specialist to join our team at Elanco. As a key member of our production team, you will be responsible for performing biologics recovery and purifications using process scale TFF units, columns, and chromatography systems.

Responsibilities
  • Operate and maintain production instruments and equipment, including pH meters, conductivity meters, spectrophotometers, TFF equipment, peristaltic pumps, rotary pumps, and chromatography systems.
  • Perform column packing using packing skids and integrity testing on various types of filters and process analysis using spectrophotometers.
  • Write and review batch records, SOPs, and qualification documents for downstream operations.
  • Purchase raw materials and production items and update SAP as required.
Requirements
  • High School Diploma or GED
  • 1+ years of experience in purification of biologics using large-scale TFF and chromatography
  • Experience with Outlines of Production, cGMP guidelines, and HSE regulations
Preferred Qualifications
  • 2-year biotechnology diploma or bachelor's degree in a life science (Biochemistry, Chemistry, Chemical Engineering, Biology)
  • 1+ years of pharmaceutical/biological manufacturing experience in a GMP environment
  • Experience performing investigations and writing deviations
  • Intermediate computer skills using MS Office (Word, Excel, PowerPoint)
  • Thorough technical understanding of quality systems and regulatory requirements
Additional Information
  • 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.

Elanco offers a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose. Some highlights include:

  • Weeklong shutdown
  • Pension Plan and Retirement Savings Plan Options
  • Discounted Employee Stock Purchase Plan
  • Flexible comprehensive health & dental with flex credits
  • Wellness and Lifestyle Spending accounts
  • 9 Employee Resource Groups

The salary range for this position is $52,000 to $65,000, which will be determined based on relevant experience and education.