OmniaBio: Manufacturing Supervisor

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.comto learn more.

Position Summary: 

As a Manufacturing Supervisor at OmniaBio, you will be experienced in cell and gene therapy manufacturing and leading small teams. The person in this role will be a leading member of a high performing team focused on production projects adhering to Good Manufacturing Practices (GMP). This role is site-based at OmniaBio’s location in Hamilton, Ontario, and involves working regularly scheduled 12-hour shifts. The primary purpose of this role is to lead the shift-based team in the execution of manufacturing activities and provide manufacturing expertise in support of OmniaBio’s client service provision to manufacture life-saving cell and gene therapies.

Responsibilities:

• Follows OmniaBio’s policies, standard operating procedures and GMP documentation, adhering to Good Documentation Practice.
• Ensures that good aseptic techniques and behaviours are employed in the execution of the production process.
• Operates and cleans clean room equipment.
• Supports room and equipment Commissioning, Qualification and Validation (CQV) activities associated with enabling GMP operations and the introduction of new manufacturing processes.
• Ensures that classified space within the manufacturing area is maintained in a clean and safe state of control.
• Drives standards to ensure the health and safety of co-workers and visitors to the manufacturing area.
• Leads the manufacturing input for investigations to derive root causes of non-conformance activities.
• Adopts the OmniaBio Operating Model (OBOM) and embraces a continuous improvement approach to all work activities.
• Ensures team members are engaged in training and development, and adequate support is in place.
• Liaises with the Supply Chain team to ensure materials are available to support the manufacturing plan.
• Utilizes the SAP enterprise resource planning system to support manufacturing activities.
• Provides expertise in cell and gene therapy manufacturing execution to aid the guidance and support of shift team members.
• Provides supervision and drives standards within the work group to ensure client and compliance needs are met.
• Ensures clear and accurate communication is maintained within the shift team and with off-going and incoming shift teams.
• Leads performance management and development of a shift-based work group (10+ staff).
• Liaises with peers and management to ensure that adequately trained and competent resources are in place to execute the manufacturing plan.
• Reviews Master Batch Records (MBR) to ensure they adequately represent process needs and are written to enable logical process flow and ease of comprehension.
• Ensures executed batch records follow ALCOA principles and issues are identified within the shift working period.
• Signs off to signify approval of executed batch record pages upon completion.

Qualifications and experience:

• Two-year college program plus eight years minimum of relevant manufacturing experience.
• Minimum four years cell therapy or viral vector manufacturing experience.
• Strong English written and verbal communication skills.

Desired Competencies and Behaviors:

• Able to learn.
• Possesses integrity.
• Demonstrates resilience and tenacity.
• Diligent.
• Able to work in a team.
• Demonstrates interpersonal awareness.
• High-energy.
• Able to work independently.
• Able to influence others.
• Demonstrates leadership.