Operations Manager

Job Title: Operations Manager,

Department: Deliver

About CCRM:

CCRM, based in Toronto, Canada, is a unique not-for-profit group that is developing and commercializing cell and gene therapies and regenerative medicine technologies. We are leveraging our network of academics, industry partners and investors to tackle significant problems and advance our most promising technologies to the market to meet the needs of patients. For more information about CCRM, please visit our website at http://www.ccrm.ca.

Role Summary:

As Operations Manager of Deliver, a business unit of CCRM that operates the Centre for Cell and Vector Production (CCVP) facility, you are a seasoned individual in the field of good manufacturing practices (GMP) manufacturing of cell and gene therapy products who is driven by the opportunity to enable clinical translation of cell therapy and regenerative medicine. You will lead and develop CCVP’s manufacturing services, including fee-for-service work, contract manufacturing, access services, support technology transfer, and technical and process development services to cell and gene therapy and regenerative medicine producers. You will provide technical expertise and will be responsible for customer engagement, communication to customers, leadership, personnel and management, and will ensure the high-quality delivery of contract services. You will be a leader in understanding how to overcome cell manufacturing challenges to enable life-saving advances in cell and gene therapy and regenerative medicine.

Responsibilities:

Operational Responsibilities

• Create, refine and implement, with the assistance of the Senior Director GMP Operations, a production strategy for contract manufacturing services for cell therapy (autologous and allogeneic cell and gene therapies) and viral vector production (adeno-associated virus (AAV) and lentivirus) for industry and academic clients.

• Recruit, hire, develop and lead the GMP production team to offer manufacturing, training, access, fee-for-service and technology services to cell therapy and viral production clients.

• Ensure all operations within the cell and viral production group conform to Ontario Health & Safety (OSHA) standards and good practice (GXP) standards.

• Work collaboratively with facility maintenance, MSAT, Supply Chain, Quality and project managers to develop scheduling windows within manufacturing operations with respect to facility maintenance, to support qualification of ongoing operations, periodic engineering projects and product/process transfers.

• Oversee preventative maintenance and calibration plans, schedules, strategies to minimize facility down-time of the CCVP facility as well as the short and long-term improvements and maintenance. Manage production schedule and resolve issues that may arise because of process development that impact agreed-to production schedules.

• Work with supply chain and logistics to create and manage supply-chain materials and storage systems.

• Support the creation of client production budgets that align with current and future business objectives.

Expertise-Related Responsibilities

• Continuously grow and adapt in a fast-moving field to keep yourself and the organization at the forefront of the cell and gene therapy and regenerative medicine fields.

• Provide expertise in presentations, white papers or other formats to communicate CCRM’s expertise to our industry colleagues and partners.

Support to Business Development

• Assist CCRM’s contract services and business development teams as required to attract clients and finalize service agreements.

• Engage potential clients as a member of CCRM’s management team by providing tours of the CCVP to promote collaboration, technology partnerships, manufacturing agreements and network/relationship building.

• Represent CCRM and promote its mission and capabilities to others in the cell and gene therapy field through participation at conferences, symposia, other venues and customer visits.

• Interface with academic and industry partners to ensure meaningful engagement and collaboration.

General Management Responsibilities

• Perform supervisory responsibilities, including training Operations Staff, planning, assigning, and directing work, appraising performance, and ensuring adherence to all Company Policies and Procedures.

• In combination with colleagues, assist in creating, communicating and implementing the organization’s vision, mission and overall direction within the operations department of the Deliver business unit.

• Provide regular updates of progress, successes and challenges to achieving goals and metrics to the Senior Director, Operations and other CCRM executives as requested.

• Provide insight into business metrics associated with your department with the intent of identifying and developing plans to improve efficiencies, optimize costs and grow productivity.

• Demonstrate the CCRM values of purpose, integrity, excellence, accountability and collaboration, and motivate others to do the same.

Requirements:

• Master’s and/or bachelor’s degree in a life sciences discipline (bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, microbiology, chemistry, etc.).

• 5-8 years of experience in cell therapy/viral manufacturing, or similar, within the pharmaceutical, medical technologies, biologics or similar industries.

• 5-8 years experience managing GMP operational activities for a contract manufacturing organization (CMO), a third-party testing facility, clinical trial program or a biotechnology company performing similar activities.

• Minimum of 3 years of proven leadership/ supervisory experience,

• Working knowledge of quality and regulatory requirements for the Cell and gene therapy products.

• Excellent capacity planning skills and experience with systems and processes (software or paper-based) for program/production scheduling, tracking and reporting.

• Strong understanding of cell manufacturing processes and technologies.

• Strong English written and oral communication skills.

• Must be able to travel domestically and internationally up to 10% of the time.

• Due to production schedules, must be available to work evenings, nights and weekends depending on client needs.

Desired Characteristics:

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

• Proven ability to monitor Operations /manufacturing Teamwork, ensuring quality, accuracy, and thoroughness; able to self-motivate and to motivate a larger Team.

• Experience establishing customer-facing organizations and service models.

• Independent, detail-oriented, self-starter with excellent analytical skills and the ability to multitask and succeed in a team environment.

• Leads by example by proactively identifying problems and areas for improvement.

• Driven by understanding, meeting and exceeding customers’ expectations and requirements.

• Takes a collaborative approach to working with cross-functional teams, with good multicultural awareness.

• Demonstrated initiative and the ability to deliver high quality outcomes.

• Experience in supporting sales and operations planning (S&OP) and integrated business planning.