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Biologics Production Specialist

1 month ago

Charlottetown, Prince Edward Island, Canada Elanco Full time

Job Summary:

We are seeking a highly skilled Biologics Production Specialist to join our team at Elanco. In this role, you will be responsible for performing biologics recovery and purifications using process scale TFF units, columns, and chromatography systems.

Key Responsibilities:

  • Operate and maintain production instruments and equipment, such as pH meters, conductivity meters, spectrophotometer, TFF equipment, peristaltic pumps, rotary pumps, and chromatography systems.
  • Perform column packing using packing skids, integrity testing on various types of filters and process analysis using spectrophotometer.
  • Write and review batch records, SOPs, qualification documents for the downstream operations.
  • Purchase raw material/ production items and make required updates in SAP.

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:

  • A 2-year biotechnology diploma, a bachelor's degree or post-secondary education in a life science (Biochemistry, Chemistry, Chemical Engineering, Biology) is preferred.
  • 1+ years of pharmaceutical/biological manufacturing experience in GMP environment is preferred.
  • Experience performing investigations and writing deviations.
  • Intermediate computer skills using MS Office (Word, Excel, Power Point).
  • Thorough technical understanding of quality systems and regulatory requirements.
  • Excellent interpersonal skills, both communications and written.

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 Benefits and Perks:

We offer 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.