Downstream Processing Specialist

3 weeks ago

Charlottetown, Prince Edward Island, Canada Next Level Group Full time
Job Title: Downstream Processing

At Next Level Group, we are seeking a highly skilled and experienced Downstream Processing professional to join our team. 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 large-scale TFF and chromatography systems.

Responsibilities:
  • Adhere to the principles of safety first, quality always, and ensure compliance with cGMP guidelines and HSE regulations.
  • 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 a spectrophotometer.
  • Write and review batch records, SOPs, and qualification documents for downstream operations.
  • Purchase raw materials and production items and update SAP as required.
  • 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.
  • Assist in the maintenance of production equipment and cleaning and sterilizing items used in downstreaming applications.
  • Maintain the cleanliness of production areas and assist in disinfection procedures as needed.
Qualifications:
  • 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.
  • Ability to read, write, understand, and comply with appropriate standard operating procedures.

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