Testing Facility Lead - Hamilton, ON, Canada - OmniaBio

Description

Reports to:
Manager, 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 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.

Delivers QC-related services as contracted, to various cell and viral product-centered clients.
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.

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.

Prepares, reviews and manages deviations, corrective and preventative actions, change controls, etc.

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.

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.
~ Food and Drug Administration GMP regulations and quality assurance principles.

Sound knowledge of applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine, such as GMP, ISO, or medical device development.

Demonstrated 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.