Offerte di lavoro a distanza e da casa in Canada ∙ Pagina 5

Responsibilities:

• Perform and/or support QC testing activities for samples generated for release testing, with a focus on Cell Suspension for Injection (CSI) for the bemdaneprocel program for human clinical trials, as well as materials used in production of CSI.
• Drive the documentation workflow to issue Certificate of Analysis for testing performed at internal and external hubs in compliance with established SOPs and regulatory standards
• Liaise with CROs and/or external collaborators to receive and complete reporting of external testing results
• Escalate out-of-specification results by following communication plans and liaise with management and related teams to resolve deviations and/or out-of specification results.
• Additionally, support process implementation for sample receipt, and in-process and release testing of raw materials, cell banks, process intermediates, drug products and other materials for other clinical programs, where needed
• Perform method verification for compendial methods, and procedural training of additional members of the QC testing team
• Support authoring and review, drive approval of SOPs related to quality control testing including test methods, and equipment operation and maintenance procedures, where applicable.
• Support Quality Assurance (QA) documentation functions for cGMP production, in-process testing and release testing of cell therapies.
• Support QA and QC functions for laboratory operations, including equipment maintenance, review and tracking of samples, testing results, materials inventory and reagent preparation.
• This position requires occasional weekend and some differential shift work hours.
• Other duties as required.

Minimum Requirements:

• BSc in Life Sciences with 2+ years of work experience or Masters with 0+ years of work experience with relevant background in Cell Biology, Genetics, Biotechnology, Biochemistry, compendia methods or related field.   
• Working knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) is strongly preferred.
• Knowledge or Experience in one or more of the following methods preferred: Endotoxin USP<85>, Sterility USP <71>, pH USP <791>, Osmolality USP <785>, cell counts for cell therapy etc.
• Knowledge or hands-on experience in the following areas is highly desirable: cell therapy, pluripotent stem cells
• Excellent written and oral communication skills, with keen attention to detail and highly organized. 
• Demonstrated flexibility in adjusting to changing priorities and schedules.
• Ability to work under moderate supervision in a fast-paced, collaborative environment with a team-oriented focus.


• Target Base Salary - $72,000 - 85,500