Offre d'emploi






DS Purification specialist / Engineer (MSAT)



Référence 153310
Localisation Dakar / Sénégal
Expiration 25 Janvier 2025
Offre visitée 114 fois
Catégories
Ingénierie, Etudes, Projets, Recherche
Santé, Social, Sport
Services hospitaliers, Médicaux
.
Description de l'offre

Title : DS Purification specialist / Engineer (MSAT) H/F
• Reference : DSPURSPEMSAT/IPD2025
• Département : MSAT
• Hierarchy N+1 : MSAT Manager
• Location : Pasteur Institute Site in Diamniadio
• Contract : CDD / CDI
• Desired start : ASAP


About the Institute
The Institut Pasteur de Dakar (IPD) is a Senegalese public utility foundation dedicated to public health, research, innovation and education in Africa. Since its foundation in 1896, the institute has continued to develop for the benefit of the population and is today specialized in the following 5 areas:

• Research & Development
• Diagnosis, vaccination, food and environment
• Education, training and talent development
• Expertise and strategic orientation in public health
• Production and distribution of vaccines and medical devices

Uniquely, IPD brings together key capabilities and functions to address public health challenges and global threats – and plays an important regional role in its partnerships with WHO and the fight against infectious diseases.
At IPD, we inspire, educate and attract passionate and visionary Women and Men of Science to develop meaningful and effective solutions to public health problems in Africa! Our Ambition is to lead, influence and improve human health, every day, in a safe and sustainable manner.
If you have the Pasteurian spirit, like us, Join Us


Activities of the position
Job description and the role
IPD is looking for an energetic and talented individual to join the Manufacturing Science and Technology (MSAT) team in the role of Manufacturing Sciences and Technology DS purification specialist/engineer (MSAT). The incumbent will support the vaccine manufacturing operations from commercial readiness through PPQ and ongoing commercial production, onsite at contract manufacturing organizations (CMO), with the primary responsibility to provide technical and operational support of manufacturing operations that ensure robust and efficient manufacturing processes.


Duties and responsibilities
• Work cross functionally with program management, process development, quality, facilities, regulatory, finance, logistics, clinical supply, and CMO / supplier management to ensure manufacture under GMP of vaccine products.
• Work closely collaboration with the Manufacturing, Quality & Compliance, and Product Development/MSAT teams to meet regulatory requirements and ensure successful CGMP manufacturing operations. Lead all aspects of and engage in the planning, design, execution, and documentation of DS purification process Investigations and CAPAs.
• Responsible for supporting the design, development, and optimization of Drug substance manufacturing processes.
• Responsible of the validation of Drug substance purification processes, including writing and reviewing validation protocols and reports.
• Drive continuous improvement and change management in Drug substance processes through technological innovation and application of first principles in process engineering.
• Leverage literature, industry/regulatory guidance, and practical experience to perform work and influence CMC strategies.
• Provide technical support for troubleshooting and resolving manufacturing issues. Recommend and implement new technology that advances knowledge and productivity within the department. Drive continuous improvement.
• Author and review technical reports, manufacturing documents, regulatory submissions, and publications.
Present at department, project team, and senior management meetings. May present externally at scientific conferences.
• Support IPD manufacturing teams during inspections of health authorities where necessary and ensure proper follow-up of any potential observation or recommendation.

Search profile
Essential skills, experience and competencies
The successful candidate will have the following skills and qualities :
A skilled technical leader with expertise in vaccine production, product recovery, and purification and Drug substance manufacturing
• An exceptional team player who works seamlessly with others, speaks up, and remains focused on achieving the best results to attain company goals.
• The ability to analyze data and communicate conclusions, decisions and recommendations concisely to key stakeholders.
• A strong sense of ownership and accountability ; commitment to IPD’s mission of protecting humankind.
Personal qualities
Strong interpersonal and leadership skills. Ability to communicate effectively both verbally and in written formats.
Experience with Cross-Functional teams and managing direct reports. Proven technical leadership skills including strong project management skills.


Education required
• Master’s degree in Bio/Chemical Engineering or Microbiology/Chemistry/ Biochemistry with 6+ years of relevant Pharma/Biotech industry experience.
• Experience with Vaccine manufacturing processes is preferred.
• Strong experience in Drug substance purification process under GMP regulations required. Understanding of Quality systems. Experience in Drug substance process equipment specification and qualification preferred.
• Strong scientific or technological (process engineering) background and hands-on experience in Inoculation, cell culture, fermentation and harvesting. In process control experience is preferred.
• Deep knowledge of In-depth understanding of vaccine manufacturing principles, purification systems and Drug substance processes/control systems.
• Drug substance / sterile manufacturing
• Production process/control systems.
• Strong ability in troubleshooting equipment/technology and process. Adept at FMEA. Excellent analytic skills.
• Experience in Investigations and development and implementation of CAPAs preferred.
• Experience with facility fit assessment, facility start-up, technology transfer, process validation, and scale-down studies implementing DOE desired.


The Pasteur Institute of Dakar is a reference employer that offers working conditions favorable to professional development.





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