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Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Institut Pasteur de Dakar Executive Leadership in Pharmaceutical/Biopharmaceutical CMC/Operations, GMP Design/implementation/CQV and Digital TransformationIPD is hiring an experienced and talented team to help establish Davax, a Clinical Biomanufacturing Facility in Senegal, and lead the unit’s operations to enable the biomanufacturing of vaccines and biologics to be translated into Investigational Medicinal Products (IMPs) for use in clinical trials and regional stockpiling for outbreaks. IPD’s vaccine pipeline includes candidates for Measles/Rubella, Rift Valley Fever, Filoviruses, and Lassa fever. The new facility will serve to bridge IPD’s Vaccine Research Centre at the historic campus in Dakar, with expertise in next generation technologies, and MADIBA, IPD’s newly built high-volume vaccine production site in Diamniadio. Davax will therefore integrate a highly flexible series of technology platforms, anchored initially around cell culture and RNA, to deliver on IPD’s vision and mission. The Davax facility is being established with support from the African Union as a Regional centre of excellence in R&D for CMC, process development and GMP pilot plant, and is made available to global partners intending to deploy new products for clinical trials, for production, for regulatory approval and ultimately commercialisation in Africa. For this 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 QA, QC and DS specialists/engineers (MSAT). The incumbent will need to spend 12 Months as part of a training program to support ongoing production, onsite at Clinical Biomanufacturing Facility (CBF), with the primary responsibility to provide technical and operational support of manufacturing operations that ensure robust and efficient manufacturing processes. This position will primarily be located in Oxford, UK. This position will require the candidate to manage the highly complex drug manufacturing processes for CBF. This is an exciting opportunity to join an outstanding team, with a mission to support clinical manufacture, launch, and commercial operations for the vaccine business. The successful candidate will demonstrate the following skills and qualities: A skilled technical leader with expertise in drug production, product recovery, and purification and drug product manufacturing An exceptional team player who works seamlessly with others, speaks up, and remains focused on achieving the best results to attain the foundation’s goals. The ability to analyse data and communicate conclusions, decisions and recommendations concisely to key stakeholders. A strong sense of ownership and accountability; commitment to IPD’s mission of saving and protecting lives. For the QA position: Responsibilities Essential Functions: Work principally in the Quality Assurance department. Write, review and implement SOPs, Working instructions, Policies, Forms and other documents. Work closely and support production (DP) as well as the MSAT QC teams to meet regulatory requirements and ensure successful CGMP manufacturing operations. Engage in documentation management. Involved in operations management. Leverage literature, industry/regulatory guidance, and practical experience to perform work and influence CMC strategies. Author and review technical reports, manufacturing documents, regulatory submissions, and publications. Present at department, project team, and senior management meetings. Present externally at scientific conferences. Desired Profile Requirements: Master’s degree in Bio/Chemical Engineering or Microbiology/Chemistry/ Biochemistry with 5+ years of relevant Pharma/Biotech industry experience. Experience with quality management is preferred. Experience in drug production under GMP regulations is preferred. Understanding of Quality systems. Strong scientific or technological (process engineering) background and hands-on experience with production. Environmental monitoring is preferred. 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 analytical skills including strong project management skills. Bilingual is a must (French and English) For the QC position Essential Functions: Work mainly in QC department for product testing, method development and implementation. Work closely and support the Manufacturing (DS and DP) as well as the MSAT QC teams to meet regulatory requirements and ensure successful CGMP manufacturing operations. Engage in the planning, design, execution, and documentation of QC process Investigations and CAPAs. Conduct method transfers from internal and external laboratories, and perform method validation, qualification, and verification in accordance with regulatory guidelines. Drive continuous improvement and change management in QC 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. Author and review technical reports, manufacturing documents, regulatory submissions, and publications. Present at department, project team, and senior management meetings. Present externally at scientific conferences and partner meetings. Desired Profile Requirements: Master’s degree in Bio/Chemical Engineering or Microbiology/Chemistry/ Biochemistry with 5+ years of relevant Pharma/Biotech industry experience. Experience in Drug Substance or/and drug product analytical testing is preferred. Experience in Drug Substance/Drug Product analysis under GMP regulations required. Understanding of Quality systems. Experience in Drug Substance/Drug Product quality control equipment specification and qualification preferred. Strong scientific or technological (process engineering) background and hands-on experience with bioanalytical testing, product stability, and sterility testing. Environmental monitoring is preferred. Sound knowledge of: Drug product / sterile manufacturing Process analytics/control systems 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. Bilingual in French and English For the DS Position Essential Functions: Work principally in the production department for Drug Substance upstream and downstream. Work closely and support the Quality unit (QA and QC) to meet regulatory requirements and ensure successful CGMP manufacturing operations. Engage in documentation management. Support the design, development, and optimization of Drug Substance manufacturing processes. Involved in the validation of Drug Substance 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. Author and review technical reports, manufacturing documents, regulatory submissions, and publications. Present at department, project team, and senior management meetings. Present externally at scientific conferences and partner meetings. Desired Profile Requirements: Master’s degree in Bio/Chemical Engineering or Microbiology/Chemistry/ Biochemistry with 5+ years of relevant Pharma/Biotech industry experience. Experience with drug substance manufacturing process is preferred. Experience in Drug Substance production under GMP regulations required. Understanding of Quality systems. Experience in Drug Substance/Drug Product equipment specification and qualification is preferred. Strong scientific or technological (process engineering) background and hands-on experience with production. Environmental monitoring is preferred. 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. Bilingual in French and English. Seniority levelSeniority level Mid-Senior level Employment typeEmployment type Full-time Job functionJob function Quality Assurance Industries Research Services Referrals increase your chances of interviewing at Institut Pasteur de Dakar by 2x Get notified about new Quality Assurance Specialist jobs inOxford, England, United Kingdom . 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