Manager, B100 Support Process Validation

Job type: Full-Time
Accepting BioReady™: Yes
Category: General Management, Operations and Administration
Experience: 4-6 Years
Employer: Sanofi
Location: Toronto, ON
Posted: November 18, 2022
Closes: December 18, 2022

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.

Position Summary:

The Manager, B100 Support Process Validation will report directly to the B100 MTech Deputy Director, Cleaning & Support Process, with the following key accountabilities:

• Manage and lead support process validation activities pertaining to the B100 start-up facility project and the MTech project organization.

• Deliver a strong and comprehensive support process validation program and package for: media and buffer preparation processes.

• Manage and provide technical leadership for the strategy, planning and execution of support process validation activities

• Support commissioning and qualification (C&Q) of media and buffer preparation and delivery systems, as well as C&Q of other manufacturing and supporting systems

• Manage and support qualification and implementation of single-use applications

Key Responsibilities:

Technical Direction and Management:

General:

• Support the transfer and optimization of existing legacy processes.

• Support execution phases of the B100 project (validation, start-up, ramp-up) in coordination with Operations, Technical services, Quality and RA.

• Lead/build process validation team to assure the required discipline for successful execution/completion of deliverables .

• Network with local and global experts/ SPPs as necessary, leveraging knowledge/data where possible.

• Assist with the discussions and interactions with the regulatory agencies where required.

Manage and provide support process validation expertise for media and buffer processes:

• Ensure the development suitable strategies for validation including but not limited to process validation, filter validation.

• Ensure the development of effective and consistent processes for preparation of buffers and media.

• Support technical aspects of outsourced manufacturing.

• Ensure comprehensive supportive studies for example mixing studies and hold studies.

• Ensure preparation, review and approval of protocols and reports as per project schedule.

• Provide technical risk assessments and gap analysis.

Transversal Expertise and Management:

• Support execution phases of the project (validation, start-up, ramp-up) in coordination with Operations, Technical Services, Quality and RA.

• Manage Process Validation team to assure the required discipline for successful execution/ completion of deliverables .

• Lead media and buffer preparation and antigen manufacturing and validation to assure the required discipline for successful execution/completion of deliverables.

• Network with local and global experts/SPPs as necessary, leveraging knowledge/data where possible.

• Assist with the discussions and interactions with the regulatory agencies where required.

• Apply sound project management tools to track execution, cost and earned-value analysis.

Compliance and Safety:

• Work within the framework of the Manufacturing Technology Team (i.e.: respecting schedule, phase gates, decision processes, design review deadlines, team culture, communication, documents, etc), with professionalism and transparency, and delivering in a timely manner in accordance with the design and execution schedule requirements.

• Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.

• Ensure operating procedures are current and followed, and site and corporate policies are adhered to ensure the project is carried out in a safe manner and safety issues are effectively resolved.

• Office environment- 25-30 hrs/ week.

• Manufacturing/Laboratory environment: 5 – 10 hrs/week.

• Full gowning during manufacturing phase (technical and consistency batches).

• May be exposed to pathogens (pertussis, diphtheria, tetanus).

• Some travel required in North America and Europe.

Dimensions/Scope

• Breadth of Responsibility: Toronto, Canada.

• Key Dimensions: Large biopharmaceutical facility project, with extensive scope and complexity in facility/ automation/process design and qualification, process improvement implementation; effective cross-functional interaction, communication and team management.

• Freedom to act, level of autonomy: interface with site management; platform heads, project leaders, global network.

• Key Requirements:

• M.Sc or Ph.D in suitable science subject biochemistry, chemistry or engineering such as chemical of process engineering.

• Minimum 8-10 years direct experience in biotech pharma/biotech manufacturing, and quality environments in a process validation role.

• 5+ years demonstrated leadership in behavioral competencies and project/people management.

• Senior technical experience and specialist expertise in support process validation including media and buffer, filter validation.

• Strong understanding and experience with single use technology, including implementation and validation of single use systems

• Strong technical writing is essential.

• Excellent communication and transversal management skills.

• Good understanding of current regulatory requirements and document preparation.

• Experience with raw materials is advantage.

• Sound knowledge in biochemistry and protein chemistry is an asset.

 

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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