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5cP Manufacturing Technology (Specialist for Process and Product, SPP)

date posted 09/11/2020
contract type Full time
job id R2565736
location Toronto, Canada

Reference No. R2565736

Position Title: 5cP Manufacturing Technology (Specialist for Process and Product, SPP)

Hours of Work:Monday to Friday: 8:00 – 4:00 p.m.

Department:  Manufacturing Assistance

Location:  Sanofi Pasteur Limited, Toronto, Ontario, Canada

Sanofi Pasteur: The world’s leading vaccine company

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 is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi Pasteur Limited is looking for motivated and results driven individuals to join our MTech Department as a Manager SPP, (Specialist for Process and Product) for 5 Component Pertussis

Position Summary:

Scientist 5cP Manufacturing Technology (Specialist for Process and Product, SPP) is the industrial process know-how guardian of specific process/product or area of activity. 5cP MTech (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 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/

  • Collaborate with SPPs from other manufacturing areas to exchange ideas and ways of working.

  • Support the MTech Process and Product Technologies platform as acting SME for different projects.

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 upstream and downstream 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/She 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 bacterial fermentation process and downstream unit operations, which includes high scale bacteria fermentation process, filtration, chromatography, fractionation, precipitation, centrifugation, detoxification, filtration, ultrafiltration, SIP and CIP.

  • 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 and 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, Biotechnology Engineering, 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-op student, 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 and Experience:

  • Minimum PhD with 5 years of industrial experience or M.Sc. (Science/Engineering) with 10 years of industrial experience

  • Candidate should possess sound knowledge of Regulatory Requirements, GMP 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, interpersonal communication, use of technical/professional expertise, resilience and balanced judgement/risk analysis.

  • Depth knowledge of technical areas specific to fermentation and downstream manufacturing processes is required. Sound knowledge in bacteria growth/microbiology, molecular biology, chromatography and protein purification

  • Expertise in process industrialization

  • 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

Sanofi is an equal opportunity employer committed to diversity and inclusion. 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 and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

Sanofi, Empowering Life

#GD-SP #LI-SP

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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