Position: Operational Manager, Clinical Manufacturing
Department: Bioprocess Research and Development
Location: Sanofi Pasteur Limited, Toronto, Ontario, Canada
Reporting to: Deputy Director, Clinical Manufacturing, BRD
Posting Date: Friday, August 11, 2017
Closing Date: Friday, August 18, 2017
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi entities in Canada include the Diabetes and Cardiovascular Care Business Unit, the General Medicines and Established Products Business Unit, Sanofi Pasteur (vaccines), Sanofi Genzyme (specialty care) and Sanofi Consumer Health. Together they employ close to 1,900 people. In 2015 Sanofi companies invested $133.3 million in R&D in Canada, creating jobs, business and opportunity throughout the country.
Sanofi Pasteur Limited is seeking an experienced, strategic and results-driven individual to join our Clinical Bulk Manufacturing team as Operational Manager, Clinical Manufacturing Platform (CMP). Reporting to the Deputy Director of Clinical Manufacturing platform (CMP), this position is available as a result of an internal development transfer. This position offers the opportunity to play a hands-on role in the development of manufacturing processes for new vaccines and the manufacturing of first-in-humans batches for clinical trials.
Responsibilities include management and shop floor oversight of cGMP manufacturing activities and the transfer and/or implementation of new technologies / equipment / processes into the platform. This position will also be responsible for increasing the quality and efficiency of clinical manufacturing in Bioprocess Research and Development (BRD), by ensuring quality compliance, and leading safety initiatives, and special projects with in CMP.
• Responsible for management of the clinical production, ensuring that project timelines and GMP requirements are met.
• Manages the daily operations of the clinical manufacturing suites, including the execution of the manufacturing processes, document preparation, training of personnel for GMP compliance, and conflict resolution. In addition, schedules work assuring all materials and resources are planned, equipment and facilities prepared to support activities. Establish and maintain networks within the company to facilitate these tasks
• Coordinates and manages the transfer and/or implementation of new technologies / equipment / processes which may be transferred locally from the Development Platforms into the CMP or originate from within the CMP. Primary focus will be bacterial and/or viral cell expansion, fermentation, recovery and purification but may include opportunities to support final product formulation, filling & packaging. Responsible for ensuring the new technologies / equipment / processes meet GMP regulations and site requirements.
• Ensures the drafting/review/approval of documentation including batch records, deviation investigations, SOPs, validation & technology transfer documents
Required Education and Experience:
• University degree BA/BSc or MS degree in Biology or related discipline along with a minimum of five (5) to ten (10) years of relevant work experience, preferably in manufacture of vaccines or biologicals. Knowledge in the areas of aseptic processing, bacterial, cell and viral culture and purification, and the associated GMP compliance & quality issues is preferred..
• Experience in preparing, reviewing and modifying GMP documentation such as batch production records, deviation investigations, SOPs and maintaining records is an asset.
• Strong leadership, teamwork and interpersonal skills are essential. It is expected this position will manage from the front line.
• Ability to work cross-functionally, including interaction with other BRD & ARD platforms, project teams, R&D SQO, site SQO, support groups such as Facilities and other functions in order to assure releasable product through proper scheduling, conflict resolution, and attention to quality.
• Innovative thinking and willingness to challenge the status quo to improve process efficiency and quality.
Sanofi Pasteur Canada embraces diversity in the workplace and is committed to achieving employment equity. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome applications from women, members of visible minorities, Aboriginal peoples and persons with disabilities.
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
We are an equal opportunity employer.
Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.
At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.