Microbiologist II, Quality Control

3 weeks ago

Ontario, Canada OmniaBio Inc Full time

Reports to: Microbiology Supervisor,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.com to learn more.

Position Summary:

As Microbiologist II, Quality Control, at OmniaBio, you are an experienced individual in the field of Good Manufacturing Practices (GMP) manufacturing. The Quality Assurance (QA) team is responsible for all aspect of GMP for the organization and the Microbiologist II, Quality Control, will be required to work specifically to maintain the environmental conditions in clean rooms by performing environmental monitoring (EM), as well as testing, sample management and data review. You will demonstrate flexibility within the QA team and larger organization, flowing to work priorities, as required. Environmental monitoring (EM) is an enabling function and, as such, this role will support production and facility needs to ensure product supply to patients. You will ensure the high-quality delivery of contract services.

Responsibilities:

  • Delivers quality control (QC) microbiology-related services including environmental monitoring, sample management, testing, method suitability, data review and equipment management.
  • Collaborates with the Production, Manufacturing Science and Technology (MSAT), Facilities and QC teams in the preparation of EM strategy and execution.
  • Maintains the EM schedule.
  • 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, EM samples and stability samples.
  • Designs, organizes and maintains the standard operating procedures (SOPs) that describe the equipment’s key functions, including operations and maintenance procedures.
  • Facilitates the training of end-users on sampling requirements, sample handling and other quality procedures, as applicable.
  • Creates equipment logbooks/records and a preventative maintenance schedule for applicable equipment.
  • Manages the third-party testing by approved partners and takes part in the qualification processes of third-party laboratories, as needed.
  • Performs aseptic gowning qualification and maintains personnel qualifications.
  • Provides in-suite and on-the-floor support for OmniaBio’s manufacturing teams, ensuring a compliant and fast-to-patient mindset. Plans and executes EM sampling for all in-suite activities. Collaborates with peers on the Production, QC and Facility teams to co-create solutions to remediate compliance and quality issues.
  • Performs room status updates, and, in collaboration with clients, ensures all EM documentation is complete and available for approval.
  • Participates in client audits and health authority audits, as required.
  • Reviews and assesses deviations, corrective and preventative actions, change controls, etc.
  • Liaises with clients and third-party contract services to ensure quality support is provided when needed.
  • 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.). Microbiology background is preferred.
  • 2-4 years of experience in a cell therapy/viral quality department supporting GMP production or similar within the pharmaceutical, medical technologies, biologics or similar industries.
  • Strong understanding of aseptic/sterile environments and technologies.
  • Excellent understanding of Health Canada/U.S. Food and Drug Administration 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 in establishing customer-facing organizations and service models.
  • Demonstrates 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.

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