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.