Raw Materials Lead, Quality Control

Reports to: Manager, Quality Control Department: Quality 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. Position Summary: As Raw Materials Lead, Quality Control, at OmniaBio, you are an experienced leader in the fields of quality control (QC) for Good Manufacturing Practices (GMP) manufacturing. The QC team is responsible for all aspects of QC for the organization, and the Raw Materials Lead, Quality Control, will be required to work across the entire range of activities, including, but not limited to, materials sampling and testing, sample management, data review and supplier audits. You will demonstrate flexibility within the Quality team and larger organization, adjusting work priorities, as required. You will provide technical expertise and will be an active contributor to client audits, communicating to customers and management. You will ensure the high-quality delivery of contract services. Responsibilities:

• Delivers QC-related services as contracted, to various cell and viral product-centred clients.
• Oversees the materials specification program.
• Oversees the release of incoming materials for manufacturing.
• Oversees/performs the sampling and testing of incoming materials, ensuring strict adherence to regulation.
• Oversees the materials sample management program, including sample identification, storage and retention.
• Reviews completed records to ensure compliance to GMP, working with colleagues on the Production and Manufacturing Science and Technology teams to remedy non-compliance and adherence to Good Documentation Practices.
• Manages the out of specification (OOS) and retest program as it relates to incoming materials, ensuring strict adherence to regulation(s).
• Ensures QC resources are made available to support client project requirements.
• Ensures QC team members have the resources and training required to fulfill their duties.
• Builds and manages QC systems, as required.
• Oversees the QC documentation program, specifically the quality management system, including standard operating procedures, logbooks and associated forms.
• Administers the documentation and training programs to the QC function.
• Collaborates with the Engineering & Facilities team to ensure that facilities are available for materials sampling.
• Manages third-party testing by our approved partners and takes part in the qualification processes of third-party laboratories, as needed.
• Participates in internal audits and/or supplier audits, as required.
• Participates in client and health authority audits, as required.
• Prepares, reviews and manages deviations, corrective and preventative actions, change controls, etc.
• Ensures GMP is embedded in all manufacturing-related tasks.
• Engages and supports the OmniaBio Operating Model continuous improvement philosophy.
• Represents OmniaBio and promotes its mission and capabilities to the cell and gene therapy field through participation at conferences, symposia, other venues and customer visits.
• Continuously grows and adapts in a fast-moving field to keep yourself and the organization at the forefront of the cell and gene therapy and regenerative medicine fields.

Requirements:

• Bachelor’s degree in science (bioengineering, chemical engineering, bioprocess, biotechnology, biochemistry, chemistry, etc.).
• 6-8 years of experience in a cell therapy/viral quality department supporting GMP production, or similar, within the pharmaceutical, medical technologies, biologics, or similar industries.
• Experience working for a CDMO, third-party testing facility or a biotechnology company performing similar activities.
• Strong understanding of cell manufacture processes and technologies.
• Excellent understanding of Health Canada/U.S. Food and Drug Administration GMP regulations and quality assurance 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 the ability to multitask and lead in a team environment.
• Experience establishing customer-facing organizations and service models.
• Demonstrated initiative and the ability to deliver high-quality outcomes.

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.