Vice President Operations

Reports to: Vice President, General Manager and Site Head

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.

Role Summary:

The Vice President, Operations, will be a key member of the Site Leadership team. The role oversees all cell and gene therapy clean room manufacturing activities, which includes various cell-based modalities and viral vector production. Products will service customer needs in support of clinical trials and ongoing commercial supply.

The Vice President, Operations, will be a seasoned individual in the field of Good Manufacturing Practices (GMP) manufacturing and organizational leadership. The person in this role will be responsible for providing oversight and support in client-facing projects and product supply. The Vice President, Operations, will represent the department in regulatory audits and provide guidance and support during client audits.

Responsibilities:

• Develops and implements all Operations Strategy.
• Designs and establishes a strategic manufacturing organization leading to 24/7 coverage of manufacturing assets.
• Be accountable for day-to-day manufacturing operations ensuring agreed-upon deliverable targets are met.
• Provides oversight of and supports manufacturing personnel to ensure employee engagement and operational success.
• Responsible for ensuring effective training programs are in place and supported to maintain and develop an effective workforce.
• Strategically leads resource allocation and project prioritization. Recruits, directs, coachs, and develops the Manufacturing team to maintain a high level of technical expertise, working collaboratively with key partners.
• Develops short-term and long-term strategic plans aligned with OmniaBio’s corporate objectives.
• Supports the development and implementation of electronic batch records and the manufacturing execution system.
• Drives health and safety performance; creates and maintains a safety-focused culture.
• Ensures the Manufacturing team has appropriate representation within customer-facing project teams.
• Collaborates with the Manufacturing, Science and Technology team to establish new production processes.
• Reviews and approves executed batch records.
• As required, leads customer technical team meetings and serves as operational lead and subject matter expert at joint project team meetings.
• Operates with a continuous improvement (CI) mindset. Provides guidance and supports CI activities and embeds the OmniaBio Operating Model as the modus operandi for the team.
• Leads budget planning process including capital equipment and material needs, staffing requirements, and contracted services requirements.
• Manages budget effectively to balance operational needs and spend.
• Utilizes operating metrics and key performance indicators to provide an understanding of performance and drive improvement.
• Embeds key skills for investigation of non-conformance and root cause derivation.
• Collaborates with the Facilities team, equipment suppliers and Project Managers to develop scheduling windows within manufacturing operations for calibration and planned maintenance.
• Ensures quality assurance oversight on all manufacturing-related activities.
• Escalates anomalies and concerns, utilizing judgement as a seasoned leader.
• Represents the Manufacturing team in leadership forums.
• Supports production schedule creation and resolves issues that may arise.
• Supports the creation of client project production budgets that align with current and future business objectives.

Business Support:

• Assists the Business Development (BD) team in the assessment of potential projects and engages with prospective and current clients; finalizes service agreements.
• Acts as escalation point with clients to tactfully manage issues arising as part of technology transfer or ongoing manufacture.
• Works with the BD team to ensure client service needs and offerings are understood and acted upon.

Qualifications:

• Degree in science (bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, microbiology, chemistry, etc.).
• 15 years of experience in cell therapy/viral production, or similar within the pharmaceutical, medical technologies, biologics, or similar industries.
• GMP experience supporting commercial manufacturing.
• 20 years of practical experience in supervising/managing/leading large teams.
• Strong understanding of biologics/cell manufacturing processes and technologies.
• Strong English written and oral communication skills.

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.
• Experience establishing customer-facing organizations and service models.
• Demonstrate initiative and the ability to deliver high-quality outcomes.
• Lead by example by proactively identifying problems and areas of improvement.
• Driven by understanding, meeting, and exceeding customers’ expectations and requirements.
• Take a collaborative approach to working with cross-functional teams, with good multicultural awareness.
• Experience in supporting sales and operations planning and integrated business planning.
• Demonstrate ability to hire, coach, and grow technical talent.

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.