Product Subject Matter Expert- Toronto/ON

Job description

Summary of Purpose/ Major Responsibilities

Act as Vaxelis Subject Matter Expert (SME) in Manufacturing Technology (Mtech).  In addition act as the main point of contact for Merck/MCM in Mtech.

·  Lead and Manage  Vaxelis projects.  Ensure validation master plans, project outlines or technology transfer plans are written, collected and integrate inputs from production, quality assurance, master data, change control and other key stakeholders. 
·  Communicate resource requirements to appropriate functions.

Support manufacturing investigations and activities by coordinating internal SP departments for Product Impact Assessments. The scope of the product impact assessments include the following:

·  Changes made to Merck antigens
·  Changes made to SP antigens

Collaborate with Site Quality Organization to escalate Vaxelis Quality Events. Lead, manage and coordinate CCR/CAPA activities for Vaxelis  product changes. Complete and manage change notification forms to Merck/MCM and SP Quality Representatives. Liaise with appropriate SME at SP TOR and SP MLE

Act as SP TOR Liaison for inter-site and Inter-company investigations. Support inter-site activities between Swiftwater,  Haarlem and Toronto.

Champion Vaxelis in Process LCM inside Sanofi Pasteur (SP). Ensure Drug substance (DS) and Drug Product (DP) are included in data generation and variation submission.

Participate and contribute to Vaxelis Convergence Plan meetings

Advocate for Vaxelis Firewall Compliance

Key Accountabilities

·  Serve as Vaxelis Product Specialist in Mtech to help secure supply by interacting with cross functional teams in Production , Quality Operations at both the SP and Merck sites. (20%)
·  Act as point of contact for Merck/MCM in Manufacturing Technology .
·  Works transversely to coordinate internal SP activities for Product Impact Assessment including inter-site activities (SWR, TOR,  Haarlem)
·  Provide process and technical expertise to new projects and process improvement projects for Vaxelis .
·  Identify areas for improvement and determine methods for achieving improvements.
·  Define equipment/system user requirements. (25%)
·  Write validation protocols and reports, execute or coordinate execution of special studies in multi-disciplinary areas, where appropriate.
·  Share knowledge and area of expertise to support projects and stay abreast of current advances in areas of technical expertise. (10%)
·  Interface as Vaxelis  representative and act as a point of contact for Merck/MCM on Manufacturing Technology.
·  Coordinate internal SP activities for Product Impact Assessment including inter-site activities (SWR, TOR,  Haarlem).
·  Lead and manage Vaxelis  projects including launch of new presentation to new markets in coordination with Site Launch leader.
·  Coordinate with internal teams to determine and execute Shipping / validation / Stability studies.
·  Lead, manage and coordinate CCR activities for Vaxelis product changes.
·  Participate and contribute to Vaxelis Convergence Plan meetings.
·  Complete and manages the change notification forms to Merck/MCM and SP Quality Representative.
·  Liaise with appropriate SME at SP TOR and SP MLE.
·  Collaborate with Site Quality Organization to escalate Vaxelis Quality Events (QN, CAPA).
·  Coordinate and lead Manufacturing Investigations for Vaxelis.
·  Act as SP TOR liaison for inter-site & inter-company investigations

Meeting Participation

·  MCM Joint Manufacturing Committee
·  MCM Project Operational Committee
·  SP Vaxelis Convergence Plan
·  SP Vaxelis Industrial Product Group – to be created / organized by IPM
·  SP Site Change Control Board – to represent Vaxelis products

HSE REQUIREMENT/STATEMENT

·  Supports investigation of work related incidents.
·  Responds promptly to all health and safety concerns or incidents and completes the appropriate documentation in a timely manner
·  Takes every reasonable precaution to ensure the health and safety of staff.
·  Encourages that protective equipment and clothing required is used by staff.                       
·  Cooperates and assists the Joint Health and Safety Committee in carrying out its functions.
·  Advises staff of any potential or actual health and safety hazard of which they are aware.

Context of Job/ Major Challenges

The Product SME is responsible/has accountability for overseeing the deliverables related to activities and projects related to Vaxelis. This is a high pressure position as you are dealing with many different functions both at the local and global levels. It is important that the incumbent works well transversely and is able to get alignment on topics. The incumbent must be able to manage multiple projects and make decisions in a high paced environment with changing priorities. The incumbent must be flexible and willing to drive change across the organizations.

Breadth of Responsibility

·  Develops strategies for process / system improvements or validation studies based on time, cost, effectiveness, resource allocation, quality and regulatory compliance, with input from management for respective functional / customer areas and with approval by direct manager.
·  Executes and manages approved strategies through to completion.
·  Coordinates local cross-functional project activities.
·  Coordinates global inter-site project activities.
·  Supports Vaxelis within portfolio.

Requirements

Education/Certifications

·  Scientific degree in relevant engineering or science discipline plus five (5) years experience in a relevant position in development or manufacturing in a biopharmaceutical company.
·  Graduate degree in engineering or science preferred.

Experience

·  Five (5) years of previous bio-pharmaceutical industry experience and demonstrated technical expertise together with people and project management skills.
·  Experience and knowledge in capital projects, facility design and start up, C&Q, validation of manufacturing processes.

Key Technical Competencies and Soft Skills                                                                                                

·  Project leadership and project management methodology, including budgeting, cost/benefit analysis, process design, process validation and change management.
·  Establishing and applying structured methodologies, such as Quality by Design (QBD), Design Space, Process Control Strategies.
·  Effective communication skills, including negotiation, conflict resolution, emotional intelligence; critical thinking and problem solving.

Job Specific Competency

·  Strong leadership and project management skills, experiences in network or functional management
·  Ability to see big picture and plan broadly; able to analyze and dissect complex situations and problems, identify technical risks and business risks, and lead the teams in constructively seeking options.
·  Excellent communication skills, able to manage effectively multiple level communications up to top management and down to project team members, able to manage cross-sites and cross-functional communications.
·  Strong decision making capability. 
·  Able to manage up. 
·  Able to present proposals effectively to senior management and drive timely decision making.
·  Good practical knowledge in drug product manufacturing process.
·  Good understanding of GMP compliance requirements.

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 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

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.