Manager, SPP (Process and Product Scientist)

5 - 7 years experience  •  Business Services

Salary depends on experience
Posted on 12/05/17
Toronto, ON
5 - 7 years experience
Business Services
Salary depends on experience
Posted on 12/05/17

Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines.

Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe.

Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.

Sanofi Pasteur Limited is looking for motivated and results driven individuals to join our MTech Department as a Upstream (Bacteria Fermentation) Manager SPP, (Process and Product Scientist)

Position Summary:

  • SPP (Process and Product Scientist) is the industrial process know-how guardian of specific process/product or area of activity. SPP major role encompasses:

  • Supports licensed products through the scientific and technical continuous improvement of the existing manufacturing process and support production on a daily basis to reach industrial excellence.

  • Drives or support problem-solving related to his/her products/process by interfacing with Bulk Manufacturing teams, Mtech, QO Validation, QO Shop Floor, QC, Process Development, Research, IPL.

  • Contributes to strategy related to specific project, process validation, scientific and technological survey and inspection and audit readiness.

  • Centralizes all the demands as unique entry point within MTech for Work Request (WR), Not planned short term activity (Hotline) and Recurrent activity (at the shop floor) and drives or support the implementations of actions plans.

  • Support the Upstream manufacturing activities, with process and operations-based expertise to support delivery of optimized, robust processes with the correct technical solutions, documentation, trained resources, and operating procedures that will ensure consistent manufacturing

Key Accountabilities:

  • Identify, monitor, assess and communicate key/critical process parameters for licensed manufacturing processes (Process Mapping creation, process book review, and regular update). Strengthen bacteria fermentation process and product knowledge through Statistical Process Control, Change Control evaluation and Out of specification/Non conformance investigations (20%)

  • Responsible for ensuring product related technical issue resolution through the Product/Process Team or through the Project Management work request process such that the technical issue does not impact the availability of product to meet forecasted demand. He is responsible for defining actions plans and for making them validate by the manufacturers and QO/RA representatives when needed (25%).

  • Responsible for identification of product/process improvements and improvement implementation either through the Product/Process Team or through Project Management Office work request process. Remain up-to-date with new product/process, and process assessment technologies.  Determine how such technologies may be applied to increase process efficiency (15%).

  • Contribute to maintain the level compliance with all cGMP regulatory standards, and sanofi pasteur Standard Operating Procedures and P&Ps through adherence to those policies and procedures. Identify, review and recommend quality improvements (5%).

  • Lead or participate on Project Teams, as Manufacturing Technology representative.  Interface with other MTech areas and other departments (e.g., Mfg, QC, QA, RA, Site Services, IPL, R&D.) for assistance.  Ensure timely completion of all team goals (10%).

  • Responsible of reporting on a regular basis the overall activities Product/Process related (5%). 

  • Responsible for developing a strong scientific network (internally and externally) around the Process/Product in order to guarantee the most appropriate evaluation of process deviation (10%)

  • Assist in supervising and training process support staff in managing continuous performance improvement.  Supervise staff in accordance with the standards of the sanofi pasteur values and all sanofi pasteur P&P.  Participate in regular staff and technical meetings, and maintain open lines of communication (5%).

  • In areas of health, safety and environmental policy: support and comply with all sanofi pasteur policies, contribute toward meeting departmental/platform goals; and demonstrate progress in preventing or reducing injuries and/or illness (5%).

  •  Sound knowledge of bacteria fermentation, which includes microbiology techniques, bacteria cultivation at small, intermediate and high scale, development of scale down models, knowledge of molecular biology, SIP and CIP, microfiltration, continues centrifugation, UF/DF unit operations and protein expression and purification.

  • Apply effective and structured troubleshooting/root cause analysis techniques for production problems as required, and potential improvements in quality and/or yield.

Context of the job/major challenge:

As the Manufacturing Technology representative on a Product/Process Team, manage continuous performance improvement for licensed products/processes and give appropriate technical assistance to current manufacturing processes in order to guarantee their reliability, compliance and competitiveness.

Assist in the supervision of Manufacturing Technology staff in accordance with all sanofi pasteur standards.  The Production Support Manager is responsible for supporting the products/processes within a functional platform (i.e., Bulk or Pharmaceutical Support).

She/he is the focal point of all the problems related to the product / process for which it is responsible (RA, IPL, Manufacturing, QO, EIT, R&D) by centralizing all the demands of improvement of the process / product.

She/he is technical, technological and scientific referent for a specific process or area of activity.

To succeed, she/he makes sure to have the global and continuous biologic knowledge of the process and the technological processes on the entrusted perimeter by gathering and by analyzing all the information allowing her/him to know how her/his process behaves in its environment (continuous exploitation of the results of production, Non conformances, Change Controls).

According to her/his level of expertise and the complexity of the product, she/he may have to insure a global role of coordination for all projects linked to a specific process/product.

The major challenges are:

  • Interface with Manufacturing teams, MTech, QC, QA, SQO, PD, R&D (when required for support) and AS&AD

  • Multi-tasking

  • Multi- scientific environment (Biology, BiotechnologyEngineering, Chemistry, Testing, Mathematics)

  • Inspection participation (both with internal and external authorities) for technical issues

  • Assist with regulatory submissions (Annual Report, Regulatory Submission Review)

  • Assist with Manufacturing issue resolution

  • Assist with Manufacturing issue prevention (CAPA)

  • Assist with short notice Customer complaints

Dimensions/Scope

  • Coordinate activities of two to four Professionals within specific platforms

  • Monetary impact on business is indirect.  Job function relates to preventive maintenance of production processes, continuous improvement and resolution of production issues.

  • Coach and train co-opstudent, summer student

  • Manage investigational testing budget for specific platform

  • Accountable for multiple products/processes within platform

  • Global travel is required (cross fertilization between sites)

Education/experience

  • Minimum PhD or M.Sc (Science/Engineering) with 5 years related experience.  Candidate should possses a familiarity with Regulatory Requirements, a working knowledge of Management, Statistical Process Control (SPC) skills and Six Sigma methodology.

  • 5+ years demonstrated leadership in behavioral competencies and management. The position also requires additional specific competencies: impact and influence, interpersonnal communication, use of technical/profesional expertise, resilience and balanced judgement/risk analysis.

  • A depth knowledge of technical areas specific to upstream manufacturing processes is required. Sound knowledge in bacteria fermentation at small, intermediate and high scale and protein purification.

  • Demonstrated technical competencies in biopharma or life science industry.

  • Demonstrated understanding of current Good Manufacturing Practices, Health and Safety, high quality standards, industry standards and their application to the manufacturing process.

  • Practical experience and knowledge in a GMP, industrial manufacturing environment

  • Equipment and process validation experience

  • Effective in trouble-shooting and root cause analysis

  • Strong leadership and management skills

  • Excellent verbal and written communication skills

Certifications

  • Six Sigma Certification would be an advantage

Applications received after the official close date will be reviewed on an individual basis. Once selected for an interview, internal employees are required to notify their manager. Sanofi in 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.

The Company believes that facilitating cross-functional development of its employees is extremely important. While posting a job internally does not guarantee that an internal candidate will be selected for the position, it does bring transparency to the hiring process and allows interested employees to inquire about or apply for the position.

Employees are encouraged to pursue their career interests within their own departments and also to consider opportunities in other departments. Employees are encouraged to consider opportunities in different department where they can utilize their transferable skills. The Company supports its hiring managers sourcing and considering qualified employees for open requisitions. The Company equally supports managers who consider the long-term needs of the organization and of its employees by fostering internal talent movement. In this way, the Company can help retain and develop its most valuable resource, its people.

R25775

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