Duration: 12 months The Technology Transfer specialist will be a member of the Manufacturing Operations team, reporting to the Technology Transfer Lead. The successful candidate would be responsible for supporting New Product Introduction, while also acting as a key contributor to the evolving site tech transfer strategy. They will be a Change Champion within the organisation and site, to bring about new products, digitisation, and ways of working Your main responsibilities
Support for developing Tech transfer program. Collaborate with the team and stakeholders to deliver GMP documents related to TT, such as Risk assessments, change controls, batch records, sampling plans, Bills of Material. Maintain and feed information delivered from Development in different digital tools such as COMET SAP, MES, and DeltaV. Manage new programs introduction schedule to ensure tasks are executed on schedule Contribute/support in various teams as Tech Transfer representative. Manages small projects with moderate resource requirements, risk and/or complexity. Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes. Supports the design and implementation of best practices in tech transfer Assist in the development of future breakthrough business solutions to reduce overall effort/risk, optimising for rapid product launch, to progress the team forward to “one-click” tech transfer. Writing, maintaining of BOM's (Bill of material) and EBR’s (Paper), gBMR (MES) and SOPs/WI’s. Support to aggregate process related knowledge and centralize for knowledge management. Ensure the highest Quality, compliance, and Safety standards. Candidate’s requirements
Degree qualification in a relevant field (Science/Technical) Minimum of 5 years of work experience in the pharmaceutical or biotech industry Familiarity with Unit Operations for mAb manufacturing. Experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems, is preferred Competent in issuing and transcribing information into documents required for manufacturing, such as BOM, Batch Sheets and DeltaV Competency in the use of automated/digital systems such as DeltaV, MES, eVal, SAP COMET Has managed a small project with a cross-functional group Working knowledge of cGMP regulations and understanding of the general principles of New Product Introduction (Tech Transfer) Professional English proficiency is required. Good knowledge of German is an asset. Competency in analysing complex situations and showing practical problem-solving capabilities Ability to work effectively as part of a team and independently. Demonstrate a desire for continuous learning, improvement, and development, while approaching problems from new perspectives
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Support for developing Tech transfer program. Collaborate with the team and stakeholders to deliver GMP documents related to TT, such as Risk assessments, change controls, batch records, sampling plans, Bills of Material. Maintain and feed information delivered from Development in different digital tools such as COMET SAP, MES, and DeltaV. Manage new programs introduction schedule to ensure tasks are executed on schedule Contribute/support in various teams as Tech Transfer representative. Manages small projects with moderate resource requirements, risk and/or complexity. Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes. Supports the design and implementation of best practices in tech transfer Assist in the development of future breakthrough business solutions to reduce overall effort/risk, optimising for rapid product launch, to progress the team forward to “one-click” tech transfer. Writing, maintaining of BOM's (Bill of material) and EBR’s (Paper), gBMR (MES) and SOPs/WI’s. Support to aggregate process related knowledge and centralize for knowledge management. Ensure the highest Quality, compliance, and Safety standards. Candidate’s requirements
Degree qualification in a relevant field (Science/Technical) Minimum of 5 years of work experience in the pharmaceutical or biotech industry Familiarity with Unit Operations for mAb manufacturing. Experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems, is preferred Competent in issuing and transcribing information into documents required for manufacturing, such as BOM, Batch Sheets and DeltaV Competency in the use of automated/digital systems such as DeltaV, MES, eVal, SAP COMET Has managed a small project with a cross-functional group Working knowledge of cGMP regulations and understanding of the general principles of New Product Introduction (Tech Transfer) Professional English proficiency is required. Good knowledge of German is an asset. Competency in analysing complex situations and showing practical problem-solving capabilities Ability to work effectively as part of a team and independently. Demonstrate a desire for continuous learning, improvement, and development, while approaching problems from new perspectives
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Technology Transfer Specialist Arbeitgeber: CK QLS
Als Arbeitgeber bietet unser Unternehmen eine dynamische und unterstützende Arbeitsumgebung, die Innovation und kontinuierliches Lernen fördert. Unsere Mitarbeiter profitieren von umfangreichen Entwicklungsmöglichkeiten und einem starken Fokus auf Teamarbeit, während sie an spannenden Projekten im Bereich der Technologieübertragung arbeiten. Zudem legen wir großen Wert auf Qualität, Sicherheit und Compliance, was unsere Mitarbeiter in ihrer täglichen Arbeit unterstützt und ihnen ermöglicht, einen bedeutenden Beitrag zur Weiterentwicklung unserer Produkte zu leisten.
