Job Summary
This role involves supporting the introduction of new products while also contributing to the evolving site tech transfer strategy. The ideal candidate will bring energy, knowledge, and innovative ideas to the team.
Key Responsibilities:
* Tech Transfer Program Development: Support the development of the tech transfer program, ensuring its smooth execution and successful completion.
* GMP Document Delivery: Collaborate with the team and stakeholders to deliver GMP documents related to Tech Transfer (TT), such as risk assessments, change controls, batch records, sampling plans, Bills of Material (BOM)
* Digital Tool Maintenance: Maintain and feed information delivered from Development in different digital tools such as COMET SAP, MES, and DeltaV
* New Program Introduction Management: Manage new program introduction schedules to ensure tasks are executed on schedule and right-first time.
* Process Description and Modeling: Support the development of process descriptions, process models, facility fits, and other TT-related documents for continuous and fed-batch processes.
* Best Practices Design and Implementation: Support the design and implementation of best practices in Tech Transfer.
* Document Writing and Maintenance: Write, maintain BOM's and EBR's (Paper), gBMR (MES) and SOPs / WI's.
Requirements:
* Educational Background: Bachelor or Master degree in a relevant field (Science/Technical)
* Work Experience: 3-5 years of work experience in the pharmaceutical or biotech industry (ideally in DS Manufacturing with single-use system)
* Unit Operations Familiarity: Familiarity with Unit Operations for mAb manufacturing
* Documentation Skills: Experience in issuing and transcribing information into documents required for manufacturing such as BOM, Batch Sheets and DeltaV
* Digital System Expertise: Experience in the use of automated/digital systems such as DeltaV, MES, eVal, SAP COMET
* cGMP Regulations: Working knowledge of cGMP regulations (certification is not enough)
* New Product Introduction Understanding: Understanding of the general principles of New Product Introduction (Tech Transfer)
* Languages: Fluent English is a must, German is an advantage
The selected candidate will be part of a multidisciplinary team and support the development of novel biopharmaceuticals.