GMP Manufacturing Trainer

Job description

FULL TIME

Reporting to the Chief Operating Officer and in collaboration with other members of the team, the GMP Manufacturing Trainer will mainly:

• Collaborate on consolidating CellCAN’s training offer in cell and gene therapy manufacturing under cGMP;
• Contribute to the creation of the training curriculum;
• Extract information from SOPs, training manuals, equipment manuals, and other source documents, in order to produce CellCAN-generic training modules/courses;
• Prepare the courses for instruction to trainees in accordance with an approved curriculum;
• Develop course content including lectures, discussions, audiovisual presentations, research relevant published studies, develop workshops and case studies with a multidisciplinary team;
• Instruct trainees according to a methodical plan;
• Prepare, administer and correct exams, and assess trainees’ progress;
• Participate in staff meetings, Educational Committee meetings, conferences and training workshops;
• Remain available for student questions, evaluations and instruction for online course enrollment;
• Train and supervise new trainers (train the trainers’ concept).
• Contribute to the publication of content (generic SOP, best practices, etc.) on CellCAN’s Extranet.
• Maintain version control of most recent regulatory guidance documents regulations and standards and disseminate updates to the Educational Committee and CellCAN team.
• Keep educational content up to date with all relevant regulatory jurisdictions.
• Other duties deemed relevant and critical to the success of the program.

Skill sets:

• Excellent teaching and pedagogical skills;
• Great organisational skills and attention to detail;
• Autonomy and ownership;
• Ability to work in a multidisciplinary team environment;
• Tolerance for ambiguity and capacity to excel in defining project parameters;
• Excellent English written and verbal communication skills;
• Working level in French written and verbal communication skills.

Required qualifications:

• At least 3 years’ experience working in a cGMP environment;
• Experience in training highly qualified personnel;
• Knowledge of health and safety regulations (Health Canada & FDA), particularly in connection to manufacturing and cell therapy;
• Experience in project management an asset;
• You will need to demonstrate competency and proficiency in passing cGMP training for cell and gene therapy production at a centre of excellence in CGT production. 

Mandate Period:
Starting as soon as possible

Workplace:
CellCAN is based at the Maisonneuve‐Rosemont Hospital in Montréal. Travel flexibility required.

Salary:
To be discussed

Please submit your applications to CellCAN's Chief Operating Officer, Vanessa Laflamme at vlaflamme@cellcan.com.

About CellCAN
CellCAN is a pan‐Canadian non‐profit organization established in 2014 as part of the Government of Canada’s Networks of Centres of Excellence. Our mission is to mobilize knowledge to improve the quality, safety and feasibility of cell and gene therapy in Canada through optimal manufacturing practices. CellCAN strives to fully exploit this potential by providing an unprecedented level of collaboration among all key players in the field of cell and gene therapy by bringing together Canada's leading cell manufacturing centres and transversal cores (manufacturing product characterization, bioengineering, ethical and legal regulatory policy) into a common seal of quality for the benefit of Canadian patients.

CellCAN is currently increasing its training offer in GMP manufacturing of cell, tissue and gene therapy for cancer immunotherapy and regenerative medicine applications.

Our corporate values are:

• Excellence
• Co-Responsibility
• Adaptability
• Fun

Other opportunities at CellCAN:

Communications, Marketing and Event Manager

Business Development Manager