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Upstream Manager
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Support, Design
Projektbeschreibung
UPS (Upstream) Manager_Biologics_Pilot Plant
Start: ASAP
Length: 1 year
Location: South of Brussels
Job title:
UPS (Upstream) Manager
Job Description:
Replace the existing USP Manager Biologics Pilot Plant, during his sickabsence. Work together with current job holder, in case of his(part time) return.
- Manage the USP production team of 8 people in preparing the USPproduction suites and equipment, for start-up and validationactivities. Participate in the start-up, validation and regulatoryapproval of Biologics Pilot Plant (Mammalian Cell Culture).
- Organize and routinely manage the Upstream suites of the BiologicsPilot Plant to ensure the efficient transfer, implementation andscale-up of manufacturing processes under development to the pilotscale (400liters and 2000liters)
- Perform cGMP (current Good Manufacturing Practice) manufacturing ofdrug substance (DS) for clinical trials (Phases I, II) from Cell BankVial through to capturing the Cell-Free Cell Culture Fluid (CCF) into aHarvest Hold Tank.
Job responsibilities:
- Organize and Manage the Upstream part of the Biologics Pilot Plant,by leading a team of 8 operators/technicians and provide the necessaryleadership to ensure the following:
- Effective training for all upstream operators and cell culturepersonnel
- Efficient implementation of cGMP Compliance concepts and integrationof the Pilot Plant into the Site Quality Systems
- Shop floor management and effective leadership of upstream productionpersonnel
- Ensure 100% cGMP Compliance levels and inspection/audit readiness
- Strive for operational excellence and achieve high success rates bypreventing/minimizing cell culture contaminations, and major deviationsleading to OOS results
- Drive effective process monitoring, data management and processlearning and highlight potential process improvements.
- Pursue continuous improvement concepts and aim for highest efficiencyminimizing cycle times and number of staff required to operate theplant.
- Participate in the transfer of processes from small scale developmentunits to the pilot plant and from pilot plant to commercialmanufacturing sites
- Work closely with and provide input to small scale development groupswith regard to platform improvements and ensuring the scalability andmanufacturability of production processes.
- Author and/or review SOPs, batch records and other production relateddocuments.
- Build and maintain effective working relationships with internalcustomers and external contacts.
Specific professional/technical expertise and key competenciesrequired:
* Master degree,
* Proven team management and leadership skills.
* Min years' experience required:
o 5 years in relevant positions (development, manufacturing, biopharmaindustry, ), preferably in cell culture based production, scale-up, ortech-transfer, at pilot scale or higher (>300 L)
* Experience/Tracecord with large scale USP bio processing,particularly involving sterility concepts, bioburden reductionapproaches, yield improvements, including systematic trouble-shooting.
* Excellent command of pilot-scale technologies and unit operationsinvolved in upstream bio processing (cell culture, bioreactors, mediapreparation, continuous centrifugation, filtration etc.)
* In-depth understanding of Regulatory and Quality requirements forclinical cGMP production of biological products under clinicaldevelopment.
* Experience of interaction with CMOs would be an asset.
* Experience of process validation, including design and execution ofvalidation support studies would be an asset.
* Language:
o English mandatory
o French mandatory
Start: ASAP
Length: 1 year
Location: South of Brussels
Job title:
UPS (Upstream) Manager
Job Description:
Replace the existing USP Manager Biologics Pilot Plant, during his sickabsence. Work together with current job holder, in case of his(part time) return.
- Manage the USP production team of 8 people in preparing the USPproduction suites and equipment, for start-up and validationactivities. Participate in the start-up, validation and regulatoryapproval of Biologics Pilot Plant (Mammalian Cell Culture).
- Organize and routinely manage the Upstream suites of the BiologicsPilot Plant to ensure the efficient transfer, implementation andscale-up of manufacturing processes under development to the pilotscale (400liters and 2000liters)
- Perform cGMP (current Good Manufacturing Practice) manufacturing ofdrug substance (DS) for clinical trials (Phases I, II) from Cell BankVial through to capturing the Cell-Free Cell Culture Fluid (CCF) into aHarvest Hold Tank.
Job responsibilities:
- Organize and Manage the Upstream part of the Biologics Pilot Plant,by leading a team of 8 operators/technicians and provide the necessaryleadership to ensure the following:
- Effective training for all upstream operators and cell culturepersonnel
- Efficient implementation of cGMP Compliance concepts and integrationof the Pilot Plant into the Site Quality Systems
- Shop floor management and effective leadership of upstream productionpersonnel
- Ensure 100% cGMP Compliance levels and inspection/audit readiness
- Strive for operational excellence and achieve high success rates bypreventing/minimizing cell culture contaminations, and major deviationsleading to OOS results
- Drive effective process monitoring, data management and processlearning and highlight potential process improvements.
- Pursue continuous improvement concepts and aim for highest efficiencyminimizing cycle times and number of staff required to operate theplant.
- Participate in the transfer of processes from small scale developmentunits to the pilot plant and from pilot plant to commercialmanufacturing sites
- Work closely with and provide input to small scale development groupswith regard to platform improvements and ensuring the scalability andmanufacturability of production processes.
- Author and/or review SOPs, batch records and other production relateddocuments.
- Build and maintain effective working relationships with internalcustomers and external contacts.
Specific professional/technical expertise and key competenciesrequired:
* Master degree,
* Proven team management and leadership skills.
* Min years' experience required:
o 5 years in relevant positions (development, manufacturing, biopharmaindustry, ), preferably in cell culture based production, scale-up, ortech-transfer, at pilot scale or higher (>300 L)
* Experience/Tracecord with large scale USP bio processing,particularly involving sterility concepts, bioburden reductionapproaches, yield improvements, including systematic trouble-shooting.
* Excellent command of pilot-scale technologies and unit operationsinvolved in upstream bio processing (cell culture, bioreactors, mediapreparation, continuous centrifugation, filtration etc.)
* In-depth understanding of Regulatory and Quality requirements forclinical cGMP production of biological products under clinicaldevelopment.
* Experience of interaction with CMOs would be an asset.
* Experience of process validation, including design and execution ofvalidation support studies would be an asset.
* Language:
o English mandatory
o French mandatory
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Medien/Design, Sonstiges