Responsibilities:
Adhere to the principles of “safety first, quality always”.
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, spectrophotometers, 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 a spectrophotometer.
Write and review batch records, SOPs, and qualification documents for the downstream operations.
Purchase raw material/ production items and make required updates in SAP.
Comply with safety requirements, cGMP, SOP, and manufacturing documentation.
Collaborate with other departments involved in GMP manufacturing for planning production, testing and product release in a timely manner resulting in the successful completion of projects.
Work cross-functional 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 in good condition as per manufacturer's specifications.
Responsibilities include cleaning and sterilizing items used in downstreaming applications.
Maintain the cleanliness of the production areas and assist in disinfection procedures as needed.
Other duties as required.
Qualifications:
2-year biotechnology diploma is required; a Bachelor's degree or Post-Secondary education in life science (e.g., Biochemistry, Chemistry, Chemical Engineering, Biology) is preferred.
1-3 years of pharmaceutical/biological manufacturing experience in a GMP environment is preferred.
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.
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.