Downstream Processing Specialist

1 month ago


Charlottetown, Prince Edward Island, Canada Next Level Group Full time

**Job Summary**

We are seeking a highly skilled and experienced Downstream Processing Specialist to join our team at Next Level Group. As a key member of our production operations team, you will be responsible for ensuring the efficient and effective recovery and purification of biologics using process scale TFF units, columns, and chromatography systems.

Key Responsibilities:

  • Adhere to the principles of safety first, quality always.
  • 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.
  • Write and review batch records, SOPs, and qualification documents for downstream operations.
  • Purchase raw materials and production items and update SAP as required.
  • Comply with safety requirements, cGMP, SOP, and manufacturing documentation.
  • Collaborate with other departments involved in GMP manufacturing for planning production, testing, and product release.
  • Work cross-functionally with the upstream manufacturing group to provide resources as needed.
  • Perform tasks under minimal supervision and within tight timelines to meet production schedules.

Requirements:

  • 2-year biotechnology diploma or Bachelor's degree in life science (e.g., Biochemistry, Chemistry, Chemical Engineering, Biology).
  • 1-3 years of pharmaceutical/biological manufacturing experience in a GMP environment.
  • 1-3 years of experience in the purification of biologics using large-scale TFF and chromatography.
  • Process knowledge of TFF filtration and chromatography.
  • Excellent interpersonal skills, both communication and written.
  • Outlines of Production, cGMP guidelines, and HSE regulations.
  • Experience performing investigations and writing deviations.
  • Intermediate/Expert computer skills using MS Office (Word, Excel, PowerPoint).
  • Thorough technical understanding of quality systems and regulatory requirements.
  • Ability to work shift work (12-hour daytime shifts, 3-4 days/week including some weekends) and overtime as required.
  • Ability to lift, move, and maneuver small-medium sized equipment up to 25lbs.
  • Ability to stand for long periods of time and frequent ladder or stair climbing.


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