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.
SUMMARY OF PURPOSE/MAJOR RESPONSIBILITIES
- The B100 MTech Project Lead will have a focus to:
- Leads and executes project deliverables in accordance to Manufacturing Best Practices (IMPACT).
- Develop strategy, plan and lead activities to define and establish technical solutions for projects to support B100 Manufacturing Technology.
- Develop pathways for robust performance in B100 projects /products with technical and scientific solutions.
- Ensure successful inter- intra site/geography technology transfer, routine operations, opportunities to optimization and being cost effective.
- Address technical-scientific constraints, mitigation/ improvement plan with physio-chemical parameter interaction assessment with process- product performance while coordinating and leading with stakeholders; Operations, MTech, QO, Data Sci, Anal Sci, Formulation.
- Provide inputs to MTech inter/intra projects with expertise on scaled process development/performance and strengthening manufacturing process for product development.
- Lead the project activities within the MTech, with processes and operations-based expertise to support delivery of optimized processes interacting robust performance manufacturing processes with the correct technical solutions, documentation, trained resources, and operating procedures that will ensure successful and consistent manufacturing.
- Leads the design and implementation of technical solutions and process technologies, create strategy plans for validation, qualification, performance, testing and ensures timely completion of project deliverables.
- Support and lead activities to successfully implement projects within the New Materials Excellence Program while ensuring business continuity for commercial manufacturing.
- Ensures alignment with scope, cost and schedule relative to their area of responsibility.
- Lead project teams, working groups, interacts with cross functional teams: Production, B100 team, Quality operation, Technical Services, RA, R&D or other local or global functions, as needed, to support process improvements, new process/technology implementation, validation and regulatory submissions.
- The person to develop process knowledge and hands on tool to understand cross- parameter functionality with process behavior for decisions in real time
- Support/input Quality by Design (QbD) integration into B100 process optimization, where applicable
- Collaborate with data science team to optimize application of Digital tools and perform data assessment with various tools and logical analysis.
- Data mining for end-to-end Batch process
- Visualization of data.
- Measures limited to process- product integration
- Proposal from data assessment for continual improvement and process robustness
- Data analysis and finding on process-based excursion – impacts and suggestive action for solution.
- Develops and manages project plans, project execution, risks and mitigation
- Identify opportunities for improving process efficiency, productivity, and throughput and reducing waste and costs.
- Design and manages the execution of process improvement initiatives.
- Implement good project management practices and Manufacturing Technology (MTech) best practices.
- Manage and/or contribute to project strategy, budget, planning and reporting.
- Contribute to maintain the level of compliance with all cGMP regulatory standards and comply with all sanofi pasteur procedures and policies related to Quality, Health, Safety and Environment.
CONTEXT OF THE JOB/MAJOR CHALLENGES
- Interface with Production, MTech, B100, PMO, Technical Services, QO, RA, R&D (when required for support)
- Multi- scientific environment (Biology, Biotechnology Engineering, Chemistry, Testing, Mathematics)
- Assist with regulatory submissions (Regulatory Submission Review)
- Provide guidance to others on a routine basis (1 or more Technologists + Co-op student/contractor)
- Key indicators: Assure timely execution of projects within budget. Take accountability for technical accuracy.
- Freedom to act: Make strategic and critical decision to deliver project within timeline and budget. Cross functional role.
- Accountable for multiple products/processes within platform
- Global travel may be required
Education and experience:
- Specific degree, duration of experience (minimum): BSc (Science/Engineering) with minimum 8 years related experience or MSc (Science/Engineering) with minimum 5 years related experience.
- Candidates should demonstrate scientific knowledge and technical writing ability and possses a familiarity with Regulatory Requirements.
- Project leadership (PL) or management (PM) experience and/or qualifications are recommended.
- Successful applicants will be team players who have demonstrated strong organization, verbal and written communication skills together with innovative thinking and a customer focus.
- Strive for results (be achievement-oriented to positively impact project performance),
- Cooperate transversally (collaborate effectively across the organization),
- Commit to costumers (deliver solutions aligned with customer needs),
- Make decisions (make choices to positively impact business results).
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.Apply Now