Practitioner / consultant
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The National Research Council of Canada (NRC) is the Government of Canada's largest research organization supporting industrial innovation, the advancement of knowledge and technology development. We collaborate with over 70 colleges, universities and hospitals annually, work with 800 companies on their projects, and provide advice or funding to over 8000 Small and Medium-sized Enterprises (SMEs) each year.
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Help bring research to life and drive your career forward with the National Research Council of Canada (NRC), Canada's largest research and technology organization.
We are looking for a Team Leader, good Manufacturing Practices – Purification to manage the purification of biological products in a Good Manufacturing Practice (GMP) regulated facility at HHT. The Research Council Officer (RCO) would be someone who shares our core values of Integrity, Excellence, Respect and Creativity.
The Human Health Therapeutics (HHT) Research center has for mandate to support economic development through innovation in health care, including innovative therapies. The research center has a strong track record of industry collaborations, and is a major contributor to the prosperity of Canada’s small and medium enterprises (SMEs). The research center’s primary sector of activity is the biopharmaceutical industry. HHT targets SMEs in Canada developing therapeutics, biologics or vaccines, to address unmet needs in human health.
The ideal candidate will come from a biopharmaceutical organization that produce drugs or vaccines and has responsibilities related to purification activities in a GMP environment.
The selected person is responsible for providing scientific and technical leadership and effective supervision of a team of technical officers responsible for the purification of products within the GMP production plant.
- Manages the work of the technical officers and plans the production schedules to ensure the availability of sufficient human resources, skills, equipment and facilities to carry out the purification of GMP products;
- Determines the objectives, priorities and performance measures for technical officers working in the GMP purification team Establishes training and development plans.
- Ensures the regulatory compliance of the and equipment in order to support the new production plant for the generation of vaccines and GMP products;
- Serve as the technical lead and subject-matter expert (SME) while working with collaborator/clients and applicable functional area personnel, assess and resolve technical issues.
- Ensures successful technical transfers and effective process adaptation to the facility.
- Works closely with the production staff to troubleshoot process and equipment problems while ensuring appropriate and proactive client and internal stakeholder communication.
- Develops and qualifies/validates purification process for all commercial, clinical and preclinical materials.
- Reviews and approves standard operating procedures (SOPs) and batch records, internal and external (client projects) processes – related to purification - to ensure compliance with GMP requirements and internal standards;
- Participates in Health Canada and client audits and prepare responses in a timely manner.
- Identifies and addresses deficiencies in the Purification laboratory and and proposes corrective measures.
- Performes all tasks related to the implementation, monitoring and management of a purification infrastructure in a GMP production plant
Applicants must demonstrate within the content of their application that they meet the following screening criteria in order to be given further consideration as candidates:
- Significant industry experience in quality by design (QbD) guided robust and scalable downstream processes development.
- Significant experience in technical transfer (in or out), process gap analysis and process modeling (scale up and scale down)
- Significant experience in designing and execution of the process validation studies.
- Significant experience in applying protein purification and analytics for biologics in support of vaccine & biologic production projects.
- Significant experience with viruses purification in BSL- II environment
- Established experience in writing CMC document, project proposal, production documentation and reports.
- Experience in supervision of multi-disciplinary teams.
Condition of Employment Technical Competencies
- Extensive knowledge of biochemical sciences including protein purification, protein chemistry, protein characterization, and process optimization.
- Extensive knowledge in process transfer (in and out transfer), gap analysis and process modeling (scale up and scale down).
- Skillful at preparing, programming, operating and maintaining FPLC instrumentation (lab to pilot scale) and mainstream software (e.g., Unicorn).
- Skilled at working with various filtration technologies at the lab to pilot scale including, but not limited to: depth filtration, tangential-flow filtration, nanofiltration, sterile filtration, etc.
- Adept in column packing, evaluation, and maintenance for use at the lab to pilot scale.
- Ability to effectively create, modify and troubleshoot procedures for various downstream processing unit operations.
- Ability to communicate effectively both orally and writing (i.e., SOPs, presentations, guidelines, reports, and audits, etc).
- Management services - Conceptual and analytical ability (Level 3)
- Management services - Results orientation (Level 3)
- Management services - Teamwork (Level 3)
- Supervisor - Valuing people (Level 2)
This position is classified as a Research Council Officer (RCO), a group that is unique to the NRC. The RCO group uses a person-based classification system instead of the more common duties-based classification system. Candidates are remunerated based on their expertise, skill, outcomes and impacts of their previous work experience. The salary scale for this group is vast, from $56,374 to $159,364 per annum, which permits for employees of all levels from new graduates to world renowned experts to be fairly compensated for their contributions.
- A pre-qualified list may be established for similar positions for a one year period.
- Candidates must clearly demonstrate in their cover letter how they meet the education and experience factors listed on the poster. Candidates must use the education/experience criteria as a header and then write one or two paragraphs demonstrating how they meet them by providing concrete examples. In addition, the candidate is encouraged to describe in detail when, where and how he/she gained the experience. Failure to provide an appropriate cover letter will result in the rejection of your application. Candidates will not be solicited for incomplete or possible missing information.
- NRC employees enjoy a wide-range of benefits including comprehensive health and dental plans, pension and insurance plans, vacation and other leave entitlements.
- Preference will be given to Canadian Citizens and Permanent Residents of Canada. Please include citizenship information in your application.
- The incumbent must adhere to safe workplace practices at all times.
- We thank all those who apply, however only those selected for further consideration will be contacted.
*If you are currently a term or continuing employee at NRC, please apply through the SuccessFactors Careersmodule from your NRC computer.
Date Modified: 2020-07-28
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