Deliver - GMP Contract Manufacturing
- Close Date
- 30 May 2017
As the Operations Manager at CCRM within the Deliver business unit, you are a seasoned individual in the field of Good Manufacturing Practices (GMP) manufacturing of cell and gene therapy products and regenerative medicine technologies, who is driven by the opportunity to enable their clinical translation. You will lead and develop CCRM’s manufacturing services, including fee-for-service work, contract manufacturing, access services, 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 and communicating to customers, senior 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 and gene therapy manufacturing challenges to enable life-saving advances in regenerative medicine.
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.
- Establish and maintain the cell and viral production group, which will offer manufacturing, training, access, fee-for-service and technology services to cell therapy and viral production clients.
- Ensure all operations within the facility are conducted and conform to Ontario Health & Safety (OSHA) standards.
- Develop and manage scheduling with respect to facility maintenance, ongoing operations as well as periodic engineering projects.
- Develop and manage supply-chain/materials management and storage system.
- Work with senior leadership to establish budgets and plans to support the business.
- Assist in delivering CCRM’s contract services and supporting the business development team, as required.
- Deliver service, as contracted, to various cell- and viral product-centered clients.
- Engage potential clients by providing tours of the facility.
- Represent CCRM and promote its mission and capabilities to the cell and gene therapy and regenerative medicine fields through participation at conferences, symposia, other venues and customer visits.
- Interface with academic and industry partners to ensure meaningful engagement and collaboration.
- Demonstrate the CCRM values of purpose, integrity, excellence, accountability and collaboration, and motivate others to do the same.
- 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.
- Master’s and/or Bachelor’s degree in science (bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, microbiology, chemistry, etc.).
- 3-5 years of experience in cell therapy/viral production, or similar within the pharmaceutical, medical technologies, biologics, or similar industries.
- Experience working for a Contract Manufacturing Organization (CMO), a third-party testing facility, or a biotechnology company performing similar activities.
- cGMP manufacturing experience in commercial or clinical trial programs.
- Practical experience in leadership roles (supervisor, manager).
- Strong understanding of cell manufacture processes and technologies.
- Strong English, both written and oral.
- Sound knowledge of applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine, such as cGMP, International Organization for Standardization (ISO), or medical device development.
- Independent, detail-oriented, self-starter with excellent analytical skills and the ability to multitask and succeed in a team environment.
- Experience establishing customer-facing organizations and service models.
- Demonstrated initiative and the ability to deliver high quality outcomes.
CCRM 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.
Applications are due by 6:59 PM EDT on the date indicated at the top of this job posting.
Applicants must be legally eligible to work in Canada.
CCRM is committed to diversity and encourages applications from all qualified candidates. We will provide any requested accommodation to candidates with disabilities throughout the recruitment process.