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Team Lead, Good Manufacturing Practices - Fill and Finish

City: Montréal

Organizational Unit: Human Health Therapeutics 

Classification: RCO 

Tenure: Continuing 

Language Requirements: Bilingual Imperative BBB/BBB

The NRC Advantage

 

GREAT MINDS. ONE GOAL. CANADA'S SUCCESS. 

 

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.

 

We bring together the brightest minds to deliver tangible impacts on the lives of Canadians and people around the world. And now, we want to partner with you.  Let your expertise and inspirations make an impact by joining the NRC.

 

At NRC, we know diversity enables excellence in research and innovation. We are committed to a diverse and representative workforce, an open and inclusive work environment, and contributing to a more inclusive Canadian innovation system. 

 

NRC welcomes all qualified applicants and encourages candidates to self-declare as members of the following designated employment equity groups: women, visible minorities, aboriginal peoples and persons with disabilities.

 

Please advise of any accommodation measures required to enable you to be assessed in a fair and equitable manner. They are available to all candidates for further assessment. Related information received will be addressed confidentially.

Your Challenge

 

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 – Fill and Finish  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 been given the mandate to develop and product biologics to support COVID-19 fight and establish GMP capabilities for the future. Furthermore, HHT has the  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. The Human Health Therapeutics (HHT) facility is adapting into a GMP biomanufacturing facility and scale it up to be available to the Canadian health innovation system to support development of vaccines and therapeutics.

 

In addition of managing the aseptic filling of biological products in a GMP environment, the Team Leader will lead and coordinate the installation, qualification,  validation of the state-of-the-art Vanrx SA25 aseptic fill worcell and process validation, The team leader will collaborate to establish an environmental monitoring and sampling program for the fill and finish part of the process, that will enable product release.

 

The Team Leader will be responsible for the production of clinical and commercial biological products, compliant with GMPs and safety regulations.

Screening Criteria

 

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:

Education

 

Master degree in a Engineering, Science or related discipline. 

 

A combination of relevant Bachelor’s degree with significant experience may be considered, while a PhD would be considered an asset.

 

For information on certificates and diplomas issued abroad, please see Degree equivalency

Experience

 

  • Significant experience with GMP fill finish operations and drug development process.
  • Significant hands-on and supervising GMP manufacturing operations.
  • Significant experience in installation, qualification and validation of aseptic process equipment.
  • Significant experience with environmental monitoring and sampling programs.
  • Experience collaborating with investigators, consultants and collaborators.

 

Assets :

 

  • Experience with biologics.
  • Experience with isolators.
  • Experience with automation.
Condition of Employment

 

Reliability Status

Language requirements
Assessment Criteria

 

Candidates will be assessed on the basis of the following criteria:

Technical Competencies

 

  • In-depth knowledge of technical and operational aseptic fill-finish operation and process.
  • Solid verbal and technical writing/communication skills. Ability to create, review and revise SOP’s, work instructions, manufacturing process and good documentation practices.
  • Knowledge in project management.
  • Ability to troubleshoot equipment: mechanical aptitude, manual dexterity and attention to detail.
Behavioural Competencies
  • Management services - Client focus (Level 3)
  • Management services - Communication (Level 3)
  • Management services - Initiative (Level 3)
  • Management services - Networking (Level 3)
  • Management services - Teamwork (Level 3)
Competency Profile(s)

 

For this position, the NRC will evaluate candidates using the following competency profile(s): Management Services

 

View all competency profiles

Relocation

 

Relocation assistance will be determined in accordance with the NRC's directives.

Salary Range

 

 

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. 

 

In addition, the incumbent will receive the Bilingualism Bonus of $800 per year.

Notes

 

  • 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.
  • Some travelling may be required.
  • 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.

 

 

Please direct your questions, with the requisition number (10372) to:

E-mail: NRC.NRCHiring-EmbaucheCNRC.CNRC@nrc-cnrc.gc.ca

Telephone: 613-949-7685 

Closing Date: 10 August 2020 - 23:59 Eastern Time

 

 

For more information on career tools and other resources, check out Career tools and resources

 

*If you are currently a term or continuing employee at NRC, please apply through the SuccessFactors Careers module from your NRC computer.

 

Date Modified: 2020-07-27

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