Technology Transfer Specialist
Specialist Tech Transfer, Biotech Tech Transfer, Lucerne, Full-time
Duration: 12 months
Introduction:
The Biotech facility embeds the latest technologies into the early-stage clinical pipeline, helping to refine these technologies for inclusion into the late-stage and commercial launch of programs. The site provides Biologics Drug Substance manufacturing for Early Phase Clinical Supply and Technology Innovation implementation into the pipeline.
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 at the site.
Your main responsibilities:
- Support of 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 populate information delivered by Development across digital tools such as COMET SAP, MES, and DeltaV.
- Manage new programs introduction schedule to ensure tasks are executed on schedule.
- Contribute to and support various teams as a 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 and 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.
- Understanding of the general principles of New Product Introduction (Tech Transfer).
- Professional English proficiency is required. Good knowledge of German is an asset.
Right to apply: All applicants should hold an EU passport or a valid work permit. If you are interested, please send a CV to aguimard@ckqls.ch.
