.. supply needs, in addition to early-stage development and first in-Human clinical trial material services. Please visit us at omniabio.com to learn .. knowledge of Lean methodologies is an asset. Desired Characteristics / Behaviours: Displays a clear willingness to listen to others. Self-motivated with .. read more
Department: Training
About OmniaBio:
OmniaBio Inc. is a subsidiary of Toronto-based CCRM (ccrm.ca), a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies. OmniaBio’s facility will be Canada’s first commercial-scale contract development and manufacturing organization (CDMO) dedicated to cell and gene therapies and is expected to be the largest facility of its kind in Canada.
Based at McMaster Innovation Park in Hamilton, Ontario, OmniaBio will anchor a biomanufacturing centre of excellence and open in three phases between 2024 and 2026. OmniaBio has built a substantial team and continues to grow to prepare for this expansion. Benefitting from CCRM’s existing expertise and business practices, OmniaBio currently has established process and analytical development teams and contract manufacturing capabilities. OmniaBio is built upon leadership in induced pluripotent stem cells (iPSCs), immunotherapy and lentiviral vectors (LVVs). The vision is to provide focused support for clients with late clinical-stage manufacturing and commercial supply needs, in addition to early-stage development and first in-human clinical trial material services. Please visit us at omniabio.com to learn more.
About the role:
As Training Supervisor, you will supervise OmniaBio’s premier training programs in cell and gene therapy (CGT) Good Manufacturing Practices (GMP) manufacturing. As OmniaBio experiences exponential growth in the CGT ecosystem, our talented staff require a comprehensive training program to excel in their vital functions, with the goal of delivering excellence from start to finish. The Supervisor, Training will focus on the development, review and/or delivery of instructional materials; identify learning gaps; and support and train groups within our Process Development, Operations and Manufacturing teams.
As Training Supervisor, you will be a change agent responsible for driving the technical knowledge, skills and attitudes of employees throughout our organization. Additionally, you will serve as a conduit between our various locations (Hamilton, Toronto, and Guelph) to synergize training initiatives and activities. The person in this role will enhance productivity and quality of work, as well as support our employees as they build the necessary skills to successfully meet business/scientific objectives.
Key Accountabilities and Responsibilities:
- Working with subject matter experts (SMEs), the Supervisor, Training will oversee the coordination, development and delivery of training curriculum on unit operations specific to allogeneic and autologous cell therapies and viral vector manufacturing.
- Working with the Quality department, develops and coordinates annual facility specific GMP training requirements, such as operator aseptic qualification, gowning qualification, and other policies and procedures appropriate for GMP operations.
- Plans, schedules, creates and implements new training courses and develops proficiency testing together with SMEs.
- Collaborates with our partner training organization, the Canadian Advanced Therapies Training Institute (CATTI), as well as the Quality and Manufacturing business units, to develop a robust train-the-trainer program to qualify trainers in GMP manufacturing.
- Gathers feedback from employees on CATTI-led training and supports the continuous improvement of all company training.
- Conducts regular visits and observes employees entering aseptic environments to reinforce correct gowning and aseptic techniques.
- Monitors aseptic process simulation media fills and commercial runs to continuously improve existing training methodologies and develops training materials to address those opportunities.
- Administers aseptic behavior certification program for employees working in the manufacturing aseptic environment, including cleaning staff, facilities staff, etc.
- Understands investigations, corrective and preventative actions, and change controls pertaining to microbial contamination or shortcomings in aseptic techniques to further enhance training curriculum and aptitude testing.
- Coordinates/conducts dynamic and interactive GMP classroom and on-the-job training sessions.
Requirements:
- BSc with 5+ years of experience in CGT manufacturing or biopharmaceutical manufacturing, or MSc/PhD with 3+ years of experience in CGT or biopharmaceutical manufacturing.
- Training experience within the CGT or biopharmaceutical industry is essential.
- Strong and detailed knowledge and understanding of CGT manufacturing processes, related equipment, and the purpose and function of supporting processes.
- Strong knowledge of the application of GMP requirements.
- Experience applying adult learning theories, and training facilitation and delivery, is preferred. Must be passionate about training techniques/theories and training others.
- Effectively presents information and ideas formally and informally, verbally and in writing, to others in a manner that facilitates understanding.
- Able to take complex principles and concepts and break them down into teachable elements so colleagues can quickly understand.
- Able to communicate status, needs, forecasts, risks and timelines effectively to management.
- Possesses exceptional interpersonal skills and works interdepartmentally in an effective manner to achieve objectives.
- Practices safety awareness always and considers the impact of actions prior to executing activities.
- Possesses advanced computer literacy and be able to effectively use the full MS Office suite of applications.
- Possesses the demonstrated ability to handle multiple projects in a dynamic environment.
- Demonstrated successful experience working in a demanding, high-performance work environment and team-oriented culture.
- Able to think and act strategically and be willing to “roll up sleeves” for all training functions.
- Training and knowledge of Lean methodologies is an asset.
Desired Characteristics / Behaviours:
- Displays a clear willingness to listen to others.
- Self-motivated with a great attitude.
- Focused team player with a passion for people development.
- Able to work in a changing environment with evolving complexity.
OmniaBio is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.
Applicants must be legally eligible to work in Canada.
An applicant’s compensation package is finalized once the interview process is concluded and accounts for the nature of the role as well as the experience, competencies (job knowledge, skills and abilities) of the applicant and internal equity.
OmniaBio is committed to accessibility, diversity, and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.