Raw Materials Lead, Quality Control

Reports to: Senior 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 the Raw Materials Lead, Quality Control at OmniaBio, you are an experienced leader in the field of Quality Control for Good Manufacturing Practices (GMP) manufacturing. The Quality Control (QC) team is responsible for all aspect of QC for the organization and the Raw Materials Lead 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 and larger organization, flowing to 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:

• quality control related services as contracted, to various cell and viral product centered clients.
• the materials specification program.
• the release of incoming materials for manufacturing.
• the sampling, testing of incoming materials, ensuring strict adherence to regulation.
• the materials sample management program, including sample identification, storage and retention.
• completed records to ensure compliance to GMPs, work with production and MSAT colleagues to remedy non-compliance and adherence to Good Documentation Practices.
• the OOS and retest program as it relates to incoming materials, ensuring strict adherence to regulation.
• the QC resources are made available to support client project requirements.
• the QC team has the resources and training required to fulfill their duties.
• and manage quality control systems as required.
• the QC documentation (QMS) program, including SOPs, logbooks and associated forms.
• the documentation and training programs to the QC function.
• with Facilities/Engineering to ensure that facilities are available for materials sampling.
• the third-party testing by our approved partners and take part in the qualification processes (as needed) of third-party laboratories.
• Participate in internal audits and/or supplier audits as required.
• Participate in Client audits and Health Authority audits as required.
• Prepare, review and manage deviations, corrective and preventative actions (CAPA), Change Controls, etc.
• Ensure GMP is embedded in all manufacturing related tasks.
• Engage and support the OmniaBio Operating Model (OBOM) continuous improvement philosophy.
• Represent OmniaBio and promote its mission and capabilities to the cell and gene therapy field through participation at conferences, symposia, other venues and customer visits.
• Continuously grow and adapt in a fast-moving field to keep yourself and the organization at the forefront of the cell and gene therapy regenerative medicine fields.

Requirements:

• degree in science (bioengineering, chemical engineering, bioprocess, biotechnology, biochemistry, chemistry etc).
• years of experience in cell therapy/viral quality department supporting GMP production, or similar within the pharmaceutical, medical technologies, biologics, or similar industries.
• working for a CDMO, a third-party testing facility or a biotechnology company performing similar activities.
• understanding of cell manufacture processes and technologies.
• Excellent understanding of Health Canada/US Food and Drug Administration Good Manufacturing Practices (GMP) regulations and QA principles.

Desired Characteristics:

• knowledge of applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine, such as GMP, ISO, or medical device development.
• detail-oriented, self-starter with excellent analytical skills and the ability to multitask and lead in a team environment.
• establishing customer-facing organizations and service models.
• 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.