Deliver - GMP Contract Manufacturing
- Close Date
- 30 May 2017
As the Quality Manager at CCRM-Deliver, 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 CCRM’s quality assurance and quality control teams, to deliver on client demands, including fee for service work, contract manufacturing, access services, technology transfer, training 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 client audits, 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 and testing challenges, to enable life-saving advances in cell and gene therapy and 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 quality group, which will support the core Deliver activities, i.e. manufacturing, access, training, fee for service and technology services to cell therapy and viral production on behalf of external clients.
- Deliver quality related services including product release, as contracted, to various cell and viral product centered clients.
- Engage potential clients and assist CCRM’s contract services and Business Development team to prepare client contracts.
- Build and manage quality systems (deviations, training, change control, supplier quality, internal audit, etc.).
- Work with leadership to establish budgets and plans to support the business.
- Engage with Regulatory Affairs (internal) and market access regulatory boards of health (BOH) to establish first in class GMP manufacturing capabilities at CCRM.
- Assist CCRM contract services and business development personnel by providing expertise for scoping of project and drafting statement of work documents.
- Represent CCRM and promote its mission and capabilities to 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.
- 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.).
- Three to five years of experience in cell therapy/viral quality department supporting Current Good Manufacturing Practices (cGMP) 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.
- Practical experience in leadership roles (supervisor, manager).
- Strong understanding of cell manufacture processes and technologies.
- Familiarity with a Validation Master Plan (VMP), as well as qualification and validation principles.
- Strong English written and oral communication.
- Must be able to travel domestically and internationally up to 10% of the time.
- Advanced understanding of quality management systems used in cell therapy product manufacturing environments.
- 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.