Manager, New Materials Validation

at  Sanofi

OVERVIEW

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POSITION SUMMARY:

The Manager, New Materials Validation will report directly to the B100 MTech Deputy Director, Process Validation and LCM, with the following key accountabilities:

• Deliver a strong and comprehensive validation program and package with focus on new materials qualification that includes raw materials, consumables, filters and single-use technology
• Ensure selection and implementation of appropriate solutions for single-use technology.
• Manage and provide technical leadership for the strategy, planning and execution of validation activities.
• Manage activities related to procurement of single-use technology such as development of User Requirement Specifications and review of vendor proposals.

DELIVER ON PROJECT EXECUTION AND QUALIFICATION PHASES - 30%

• Support execution phases of the project (validation, start-up, ramp-up) in coordination with Operations, Technical Services, Quality and RA.
• Support C&Q strategy, planning and validation.
• Apply effective and structured troubleshooting/root cause analysis techniques for production problems as required, and potential improvements in quality.
• Oversee relevant qualification during engineering and consistency lots.
• Ensure smooth transition to routine operations following project turnover, which includes relevant training on single-use systems.
• Assist in the implementation of a manufacturing schedule to meet the post startup market demand in conjunction with Operations and other functions as required.
• Assist with the discussions and interactions with the regulatory agencies where required.

KEY REQUIREMENTS:

• Minimum B.Eng., B.Sc. or equivalent; M.Sc. preferred.
• Minimum 5 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 management.
• Demonstrated understanding of current Good Manufacturing Practices, Health and Safety, high quality standards, industry standards and their application to the manufacturing process.
• Technical experience and specialist expertise in process validation, with focus on new materials and single use design and application.
• Equipment validation experience is an asset.
• Expertise in process industrialization with practical experience in industrial manufacturing environment.
• Strong technical writing is essential.
• Excellent communication, written and transversal management skills.
• Good understanding of current regulatory requirements and document preparation.
• Effective in troubleshooting and root cause.

RESPONSIBILITIES

Reference No. R2716304
Position Title: Manager, New Materials Validation
Duration: Fixed-Term - Contract End Date: January 31, 2025
Department: B100 MTech
Location: Toronto, Ontario

KEY RESPONSIBILITIES:

Technical Direction and Management - 40%

• Manage the overall technical program (includes material assessment and qualification/validation) related to raw materials, consumables, filters, single-use technology and extractables & leachables (E&L).
• Assess new technology implementations, including closed systems and single-use technology (SUT).
• Review/Approve vendor designs/proposals to ensure alignment with process requirements and specifications.
• Develop and support qualification program for single use within a large capital project.
• Lead evaluation/suitability of use for SUT solutions (e.g. filters, tubing, connectors, containers, etc) for 5acP, Diphtheria and Tetanus processes.
• Drive and manage the E&L master plan and studies to support new in-process materials, drug substance containers, etc.
• Provide technical risk assessments and gap analysis.
• Support preparation and review of material specifications and user requirement specifications.
• Identify and evaluate material risks based on technical and quality criteria.
• Identify and implement process improvements.