VIDO
Vaccine Development Centre Production Manager
Description
The Vaccine and Infectious Disease Organization (VIDO), Canada’s Centre for Pandemic Research, is a world leader in infectious disease research and vaccine development for humans and animals. Located at the University of Saskatchewan in Saskatoon, Canada, VIDO is home to one of the largest and most advanced containment level 3 facilities in the world. To strengthen the preparedness for emerging infectious diseases we are currently expanding our infrastructure to include containment level 4 capacity, a GMP vaccine manufacturing facility, and a new animal housing facility. Our vision includes having the capacity to study any emerging disease in any animal model embracing a One Health approach to prevent emerging and re-emerging infectious diseases in humans and animals.
One of the key areas of focus at VIDO is vaccine development. The vaccine development group includes members of the Vaccine Development Centre (VDC), VIDO’s GMP compliant biologics manufacturing facility that is capable of manufacturing both human and veterinary vaccines to Phase 2 clinical trials or to commercialization, respectively.
Reporting to the Head of Regulated Vaccine Manufacturing, the VDC Production Manager is responsible for ensuring operational and project readiness of the VIDO VDC’s manufacturing suites. This includes bulk biologic manufacturing of bacterial, cell-culture, viral, subunit, and nucleic acid vaccines, as well as aseptic formulation and fill-finish of clinical, and potentially commercial veterinary products.
As a highly valued senior member of the VDC management team, the Production Manager will participate in budget, personnel, equipment, and facility planning, and is responsible for the successful execution of approved strategic and operational plans relating to biomanufacturing operations.
The Production Manager also shares some duties of a project manager, including assisting in scheduling, writing batch records, and ordering of materials and supplies to ensure timely delivery of objectives and projects.
This is a highly visible position with an above average level of accountability.
Qualifications
- M.Sc. degree in Life Sciences or related field; an advanced degree or additional certifications are an asset.
- Familiarity with all aspects of biopharmaceutical development and GMP manufacture, with at-least ten years relevant experience, including five years of managerial experience.
- Experience in a multi-product facility with extensive changeover procedures is preferred.
- Experience with large scale production of pathogens is preferred.
- Experience in a regulated Contract Development and Manufacturing Organization (CDMO) environment would be an asset.
- A thorough knowledge and proven experience with large-scale recombinant protein production in cell culture operations (stirred tank bioreactors), as well as downstream recovery and purification methods, including ultrafiltration and chromatography is required.
- In addition to cell culture, experience with bacterial fermentation technologies is an asset.
- Familiarity with the Canadian Biosafety Standard, along with the Risk Group and Containment Level classifications and requirements, is required.
- Knowledgeable in cGMP and relevant regulatory requirements, especially documentation such as SOPs and Batch Records, and with process and equipment validation.
- Strong mechanical, electrical, and electronic aptitude with excellent troubleshooting and problem analysis skillsets, including root cause analysis methodologies.
- Strong interpersonal, managerial and leadership skills with excellent written and verbal communication skills.
- At least five years of managerial and financial control experience, including coordinating and mentoring of staff, and providing constructive and effective feedback.
- At least three years of project management experience.
Duties & Responsibilities
- Responsible for leading bulk biologic manufacturing, aseptic formulation, and fill-finish activities.
- Take a leadership role to ensure safe work practices are followed in all biomanufacturing operations. Adhere to all environmental, health and safety regulations, policies, protocols and SOPs, including any VDC or equipment specific protocols.
- Participate in the recruitment, development and retainment of an effective workforce. Ensure training and challenging assignments to foster performance excellence and career development.
- Plan and coordinate all activities of production staff and support staff to maximize facility utilization and efficiencies.
- Must maintain operational readiness and minimize downtime by maintaining existing capital assets (facilities and equipment) with proactive and preventive maintenance programs.
- Liaise with building engineers and external contractors where applicable.
- Establish and monitor Key Performance Indicators (KPI’s) and other measuring systems to ensure operational performance standards are consistently met and continuously improved upon.
- Develop and/or provide critical review of process development and manufacturing documents (batch records, validation protocols, SOPs, protocols, reports, etc.). Responsible for reviewing all documentation related to biomanufacturing.
- Responds to after-hour calls during emergency situations related to safety, production break-downs, or facilities issues.
- Participate in client audits and government agency inspections.
- Assisting with project management, including defining project scopes, managing budgets, developing and maintaining schedules, and coordinating cross-functional teams to ensure timely and effective completion of project activities.
- Coordinating with both external and internal clients, and with VDC Quality, to ensure successful execution of technology transfer activities and final stages of process development.
- Monitor project deliverables and provide regular progress reports on project status.
- Perform regular risk assessments and develop/implement risk mitigation strategies as required.
- Participate in VDC budget, personnel, equipment, and facility planning. Responsible for the successful execution of approved strategic and operational plans related to facility operations.
- Develop and manage budgets and/or strategies to control operating expenditures such as capital purchases, utilities, raw materials, operating supplies, repairs, maintenance and salaries, and to ensure systems are in place to control and minimize labour overtime, emergency repairs, and other cost overruns.
- Recommend and execute capital improvement projects. Replace, or adjust facilities and equipment, when necessary.
- Keep aware of new technological developments in bacterial fermentation, mammalian cell culture, viral vector production, nucleic acid production, and downstream processing methodologies.
- As a senior member of the VDC management team, capable of working independently with minimal direct supervision.
Work Environment, Physical Demands, and Safety Considerations
- Must be willing to be vaccinated/blood tested for antibody titer for products manufactured within the facility, if required.
- Must be willing to work overtime and on a rotating schedule, which may include evenings and weekends. May be called upon at any time day or night during active operations.
- Work in environments with large mechanical equipment, piping and pumps serviced by high-pressure steam, water and air.
- Work with hazardous materials and chemicals, including biosafety risk group 2 and 3 pathogens.
- Must be willing to safely lift static weights of up to 25 kg.
- Work requires environment-specific gowning such as safety glasses, face masks or respirators, hairnets, laboratory coats, smocks, bunny suits, gloves, and steel toe shoes. Non-essential items such as jewelry, makeup or personal devices are not permitted in cleanroom environments.
Status: Permanent
Employment Group: Non-Union
Shift: Monday - Friday, 7.5 hours per day (37.5 hours per week); may be some requirement for evening and weekend work
Full Time Equivalent (FTE): 1.0
The successful applicant will be required to provide the following current verification(s) where 'Yes' is indicated below. Further information is available at: https://careers.usask.ca/tips-for-applying.php#Howtoapplyforaposition
Facility Access Screening including Criminal Record Check: Yes
Driver's License and Abstract Check: Not Applicable
Education/Credential Verification: Yes
Vulnerable Sector Check: Not Applicable
Interested candidates are asked to submit their application including a cover letter, CV, and the names of three references online. Review of applications will begin immediately; however, applications will be accepted and evaluated until the position is filled. We thank all applicants for their interest; only those candidates selected for an interview will be contacted.
For more information visit: vido.org
Note: The University believes equity, diversity, and inclusion strengthen the community and enhance excellence, innovation and creativity. We are dedicated to recruiting individuals who will enrich our work and learning environments. All qualified candidates are encouraged to apply; however, in accordance with Canadian immigration requirements, Canadian citizens and permanent residents will be given priority. We are committed to providing accommodations to those with a disability or medical necessity. If you require an accommodation in order to participate in the recruitment process, please notify us and we will work together on the accommodation request. The University of Saskatchewan’s main campus is situated on Treaty 6 Territory and the Homeland of the Métis. We pay our respects to the First Nations and Métis ancestors of this place and reaffirm our relationship with one another. Together, we are uplifting Indigenization to a place of prominence at the University of Saskatchewan.