Description Position at OmniaBio

Position Summary As a Scientific Lead, MSAT, you will oversee cell and gene therapy Good Manufacturing Practices (GMP) Manufacturing Science and Technology (MSAT) activities, which include technology transfer, process optimization and validation. This position will also provide leadership and support to the identification, evaluation, sourcing, and maturation of new innovative technologies. The responsibilities of this role include the following: providing technical leadership in client-facing projects and/or OmniaBio’s strategic projects; establishing technology transfer processes and policies; promoting manufacturing operations interactions; providing technical input and guiding manufacturing strategy; coaching and mentoring employees; prioritizing work; and, assisting in establishing long-term group direction and objectives. The focus of this role is to lead a team of MSAT Scientists and Associate Scientists who are supporting allogeneic cell and gene modified cell therapy product manufacturing processes through the planning, execution and analysis of at-scale and scale-down experiments to enhance process understanding and performance. You will serve as a subject-matter expert in client-facing scope discussions, developing internal business processes, and writing standard operating procedures (SOPs), along with protocols and reports. This position will directly contribute to the successful delivery of products in support of numerous clinical trials.

As a leader of the MSAT Team, you are responsible for the successful transfer of processes into production. As such, you are in direct contact with our clients and process development (PD) scientists. You ensure process scalability and manufacturability. In addition, you will coordinate all process relevant major deviations and process adaptations and you are responsible for continuous improvement of the manufacturing processes.

Responsibilities MSAT

Operational

• Create, refine and implement, with the assistance of Director, MSAT, a tech transfer and production strategy for contract manufacturing services for cell therapy and gene modified cell-based production for industry and academic clients.
• Manage a medium-size group of scientists whose major responsibility is to process technology transfer from PD or clients to GMP production.
• Build cross-functional relationships with other internal and external stakeholders, including, but not limited to, Process Development, Operations, Quality units, Supply Chain and Facilities.
• Serve as a subject-matter expert during internal and external audits.
• Lead process validation, process performance qualification (PPQ) and commercial campaign preparation.

Support to Business Development

• Assist Contract Services and Business Development teams to attract clients and finalize service agreements.
• Provide tours of the Toronto facility to potential clients, with the purpose of promoting collaboration, technology partnership, manufacturing agreements and network/relationship building.
• Represent the organization and promote its mission and capabilities to the CGT field through participation at conferences, symposia, other venues, and during customer visits.
• Interface with academic and industry partners to ensure meaningful engagement and collaboration.

General Management

• Responsible for resource allocation and project prioritization. Recruit, direct, coach and develop talent in the MSAT team to maintain a high level of technical expertise that works collaboratively with key partners.
• Lead the budget planning process, including capital equipment and material needs, staffing requirements, and contracted services requirements.
• Provide regular updates of progress, successes and challenges to the Director, MSAT and other executives.
• Provide insight into business metrics associated with the Deliver business unit to identify and develop plans to improve efficiencies, optimize costs and increase productivity.
• Review and approve documents, including SOPs, batch records, material specifications, and validation protocols.
• Demonstrate the organization’s values of purpose, integrity, excellence, accountability and collaboration, and motivate others to do the same.

Requirements

• PhD/M.Sc. degree in science (bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, microbiology, chemistry, etc.).
• Four plus years of experience in cell therapy/viral production, or similar within the pharmaceutical, medical technologies, biologics or related industries.
• Experience in technical oversight of GMP manufacturing operations for Contract Manufacturing Organization (CMO), a third-party testing facility, or a biotechnology company performing similar activities.
• cGMP manufacturing experience at a clinical or commercial scale.
• Strong understanding of cell/gene therapy manufacturing processes and technologies.
• Strong English as written and oral communication.
• Must be able to travel domestically and internationally up to 10 per cent of the time.

Desired Characteristics

• Sound knowledge of applicable regulatory frameworks and requirements for CGT and regenerative medicine, such as cGMP, ISO, or medical device development.

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.