Technology Control Testing Lead

3 weeks ago


Hamilton ON, Canada OmniaBio Full time

SeniorManager,Quality Control
Department: Quality
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. Benefitting from CCRM’s existing expertise and business practices, OmniaBio currently has established process and analytical development teams and contract manufacturing capabilities. 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. 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.
quality control related services as contracted, to various cell and viral product centered clients.
the sampling, testing of incoming materials, ensuring strict adherence to regulation.
the materials sample management program, including sample identification, storage and retention.
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.
Prepare, review and manage deviations, corrective and preventative actions (CAPA), Change Controls, etc.
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.
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.
Excellent understanding of Health Canada/US Food and Drug Administration Good Manufacturing Practices (GMP) regulations and QA principles.
knowledge of applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine, such as GMP, ISO, or medical device development.
initiative and the ability to deliver high quality outcomes.
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.



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