Job Description

GMP Manufacturing Specialist I

Client: Large Biotechnology Firm

Location : Toronto – Onsite

Hours – 9-5, weekend work needed

Duration: 6 months contract (possible extension)

Position Description:

The GMP Manufacturing Specialist I will work closely with GMP Manufacturing team in developing and executing cGMP manufacturing processes to support production of cell therapeutics for pre-clinical studies and human clinical trials. The Specialist I will assist in technology transfer of manufacturing processes internally and to external collaborators. Duties will include raw material ordering, inventory management, raw material preparations (e.g media, buffers etc.), assisting in cell manufacturing process, writing standard operating procedures (SOPs), and other GMP documents that are necessary for ensuring compliance with applicable U.S., Canadian and global standards.

Responsibilities:

• Perform duties as dictated by standard operating procedures for cell manufacturing and under cGMP guidelines as directed
• Perform duties in a clean room environment following cGMP guidelines and operate instrumentation as needed for cell manufacturing such as cell separators, cell counters etc.
• Assist in technology transfer of procedures from research & development environment into cGMP environment
• Assist manufacturing team for routine expansion and differentiation of PSCs, and executing qualification, and engineering studies
• Support preparation of documentation and reports for review by Quality Assurance and manufacturing management
• Assist manufacturing team in inventory management and raw material procurement
• Support validation / cleaning of equipment / facility including assisting in executing IQ/OQ/PQ protocols and prepare SOPs for equipment operation, maintenance and calibration
• Participate in required cGMP training activities including training on required SOPs and manufacturing procedures.
• Work with the manufacturing team to produce cell drug substance and product for non-clinical studies and human clinical trials by procuring raw materials, preparing manufacturing facility/equipment, and executing the approved MP
• Work with Quality Assurance to insure completion of all associated documentation to support cGMP manufacturing
• Assist QA/QC in the development of appropriate analytical methods, associated documentation as needed
• Support Quality Assurance documentation functions for cGMP production, in-process testing, and release testing of cell therapies. Work with QA to address quality events including deviations, CAPAs, OOS and other failure investigations as needed
• Support QA and QC functions for cleanroom operations including completing and tracking of equipment records for PM/calibration and cleanroom maintenance and cleaning.

Minimum Requirements:

• BS in Biology, Biochemistry, Engineering, or related field
• 0-2 years of experience in aseptic techniques and handling of mammalian cells is required
• Hands-on experience in human stem cell production is highly desirable
• Experience in PSC culture and differentiation techniques is highly desirable
• Experience in assisting SOPs writing and validation protocol for equipment and cell production processes is highly desirable
• Experience with Good Documentation Practices is preferred
• Willingness to accommodate various shift hours (evening, weekend, and holidays) is required
• Excellent written and oral communication skills and the ability to work in a fast paced, dynamic team environment is required
• Expertise using MS WORD, Excel, and database programs. Experience in working with an eQMS and/or LIMS is also desirable

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