OmniaBio: Associate II, Quality Control

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.

Department:        Quality Control

Position Summary:

As the Associate II, Quality Control, at OmniaBio, you are an experienced individual in the field of quality control (QC) for Good Manufacturing Practices (GMP) manufacturing of cell and gene therapy products, driven by the opportunity to enable clinical translation of cell therapy and regenerative medicine. The Associate II, Quality Control, will be required to work across the entire range of activities, including but not limited to, testing, sample management, equipment qualification, method development and optimization, and data review. You will demonstrate flexibility within the quality team and larger organization, managing work priorities, as required. You will provide technical expertise and will be an active contributor in client audits and communication to customers and management. You will ensure the high-quality delivery of contract services.

Responsibilities:

• Delivers quality control-related services including sample management, testing, method development, optimization, qualification and validation, stability program, data review and equipment management.
• Collaborates with the Production, Manufacturing Science and Technology (MSAT), and Quality Assurance (QA) teams in the preparation of master batch record, sampling plans, and specifications.
• Maintains the materials specification program.
• Releases materials.
• Manages the retain and references standard program.
• Manages the QC documentation quality management system program, including standard operating procedures, logbook and associated forms.
• Manages the OOT/OOS and retest program, ensuring strict adherence to regulation.
• Maintains the sample management program, including sample identification, storage and retention.
• Reviews completed records to ensure GMP compliance and works with production and MSAT colleagues to remedy non-compliance and adherence to Good Documentation Practices.
• Performs material testing in compliance with approved and current specifications, including but not limited to, incoming materials, in-process materials, drug substance materials, drug product materials, environmental monitoring samples, and stability samples.
• Participates in internal audits and/or supplier audits.
• Administers the documentation and training programs to the QC function.
• Participates in client audits and health authority audits.
• Collaborates with the Facilities and Engineering team to ensure facilities are available for production, including but not limited to, room readiness and environmental monitoring data.
• Builds and manages QC systems.
• Reviews and assesses deviations, corrective and preventative actions, change controls, etc.
• Liaises with clients and third-party contract services to ensure quality control activities are delivered at the required quality.
• Represents OmniaBio and promotes its mission and capabilities to the cell and gene therapy field through participation at conferences, symposia, customer visits and other venues.
• Continuously grows and adapts to keep OmniaBio at the forefront of the dynamic cell and gene therapy and regenerative medicine fields.
• Ensures GMP is embedded in all manufacturing-related tasks.
• Engages and supports the OmniaBio Operating Model continuous improvement philosophy.

Requirements:

• Bachelor’s degree in science (bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, microbiology, chemistry etc.); master’s degree preferred.
• 4-6 years of experience in a cell therapy/viral quality control department supporting GMP production, or similar, within pharmaceutical, medical technologies, biologics, or similar industries.
• Experience working for a CDMO, a third-party testing facility or a biotechnology company performing similar activities.
• Strong understanding of cell manufacture processes and technologies.
• Excellent understanding of Health Canada/US Food and Drug Administration (FDA) GMP regulations and QA principles.

Desired Characteristics:

• Sound knowledge of applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine such as GMP, ISO, or medical device development.
• Independent, detail-oriented self-starter with excellent analytical skills and able to multitask and succeed in a team environment.
• Experience establishing customer-facing organizations and service models.
• Demonstrated initiative and ability to deliver high-quality outcomes.