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.
SUMMARY OF PURPOSE/MAJOR RESPONSIBILITIES
The B100 MTech Media -Buffer area technical support will have a focus to:
- Support products with technical and scientific solutions for robust performance of media- buffer management in B100.
- Support the media assessment, formulation, troubleshooting on media buffer preparations, buffer concentrate, vendor developments, equipment performance.
- Optimize cost effective media- buffer supply -demand to key stake holders upstream- downstream or any other request with in B100.
- 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 component chemistry interaction assessment with process- product performance while coordinating and leading with stakeholders; Operations, MTech, QO, Data Sci, Anal Sci, Formulation.
- Lead and drive problem statement, discrepancy/deviations investigation and CAPA implementation in Media -Buffer area.
- Provide inputs to MTech inter/intra projects with expertise on scaled media- buffer development and strengthening manufacturing process for product development.
- Lead the media, buffer and sterilization activities within the MTech, with processes and operations-based expertise to support delivery of optimized media- buffer with interacting robust performance manufacturing processes with the correct technical solutions, documentation, trained resources, and operating procedures that will ensure successful and consistent manufacturing.
- Review media- buffer generation and distribution process flow diagrams, mass balances and process descriptions and process assessments/impacts including key/critical parameters.
- Review and assess vendor designs/proposals to ensure alignment with process requirements and specifications.
- Review and assess state-of the art technologies, high end equipment, design input and automation associated to Media wash and sterilization.
- For newer opportunities of improvement or the demand for product process- interface, Assess new technology implementations with stainless steel or single-use technology.
- Responsible for identification of media- buffer optimization and impact evaluation to lead 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 requirements for media- buffer, and the assessment technologies. Determine how such technologies may be applied to increase process of media- buffer efficiency.
- Lead and coordinate Media- buffer stability or other related study and coordinate with upstream/downstream team.
- Assist with the discussions and interactions with the regulatory agencies where required.
- Identify, monitor, assess and communicate key/critical process parameters for licensed manufacturing processes (Process Mapping creation, process book review, and regular update). Strengthen media- buffer process and product knowledge through Statistical Process Control, Change Control evaluation and Out of specification/Nonconformance investigations.
- Responsible for ensuring media- buffer and sterilization 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 media- buffer 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.
- Good knowledge of media and bacterial fermentation upstream and downstream unit operations, which includes large scale media- buffer preparation with technologies and control systems and look into the cycle and data on SIP and CIP for media – buffer area.
- 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.
- Lead, coordinate, participate with B100 Project Teams, as MTech representative. Interface with other MTech areas and other departments (e.g., Mfg, QC, QA, RA, Site Services, IPL, R&D). Ensure timely completion of all team goals.
- Responsible of reporting on a regular basis the overall activities of media – buffer area.
- Responsible for developing a strong scientific network (internally and externally) around the Process/Product to guarantee the most appropriate evaluation of media- buffer process deviations.
- Assist in supervising and training media/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.
- Good knowledge on bacteria fermentation, 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 supply of media management leading to respective product quality and/or yield.
- 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.
Data assessment for Sustainability and continuous improvement:
- 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 Media development/ 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.
- Implement enhanced process control strategy for ILD/ILC equipment with data generation and functional analysis for buffer distribution and generation matrix.
CONTEXT OF THE JOB/MAJOR CHALLENGES
- Full gowning during manufacturing phase.
- Some travel required in North America and Europe
- Managing change and priorities within a dynamic and shifting project schedule
- As the Manufacturing Technology representative on a APT, 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.
- She/he is the focal point of all the problems related to the media buffer wash sterilization process for which it is responsible (RA, IPL, Manufacturing, QO, EIT, R&D) by centralizing all the demands of improvement of the Media process.
- The person 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 the person level of expertise and the complexity of the media, she/he may have to insure a global role of coordination for all projects linked to a specific process/product.
- Interface with Manufacturing teams, MTech, QC, QA, SQO, PD, R&D (when required for support) and AS&AD
- 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
- 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
- Accountable for multiple media- buffe strategy within respective product- process platform
- Minimum B.Eng., B.Sc. or equivalent; M.Sc.
- Minimum 5 years of industrial experience.
- 2+ 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.
- Candidate should possess good knowledge of Regulatory Requirements, GMP guidelines.
- Depth knowledge of technical areas specific to media- buffer preparation; fermentation and downstream manufacturing processes is required. Good knowledge in bacteria growth/microbiology, molecular biology, chromatography and protein purification.
- Candidate should have good understanding of data analysis and not limited to Statistical Process Control (SPC) skills and Six Sigma methodology.
- 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 commissioning, qualification and validation experience
- Effective in troubleshooting and root cause analysis
- Good management skills
- Good verbal and written communication skills
- PMP and 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.
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