Functions, Duties, Tasks:

• Adhere to the principles of “safety first, quality always”.

• Perform sterile manipulations in both a biosafety hood and isolator.

• Maintain a cell line completing media changes and cell passages.

• Operate and maintain production instruments and equipment, such as pH meters, conductivity meters, microscopes, lyophilized, peristaltic pumps and other production equipment.

• Perform sterile cell culture and viral infection processes.

• Write and review batch records, SOPs, qualification documents for viral/Renogen operations.

• Complete timely SAP postings and maintain department inventory.

• 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 successful completion of projects.

• Work as a cross functional team with different manufacturing groups to provide resources as needed.

• Perform tasks under minimal supervision, and within tight timelines to meet production schedules.

• Assist in maintaining production equipment in good condition as per manufacturer's specifications.

• Maintain the cleanliness of the production areas and follow disinfection procedure of clean rooms.

• Responsibilities include cleaning, preparing and sterilizing items in autoclaves.

• Other duties as required.

Minimum Qualifications (education, experience and/or training, required certifications):
Biotechnology diploma would be an asset. High School (Grade 12) diploma is a must.
1-2 years of pharmaceutical/biological manufacturing experience in GMP environment is preferred.
1-2 years of experience in aseptic techniques or cell culture experience is preferred.
Excellent interpersonal skills, both communications 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, Power Point).
Thorough technical understanding of quality systems and regulatory requirements.
Other 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 and raw materials – up to 50lbs.

• Requires ability to stand or sit 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.