Job Description:
In this role, the candidate will be a key contributor to the site's evolving tech transfer strategy and play a critical part in supporting New Product Introduction.
* Support Tech Transfer Program Development: Collaborate with stakeholders to deliver GMP documents related to Tech Transfer (TT), such as risk assessments, change controls, batch records, sampling plans, Bills of Material (BOM).
* Maintain Digital Tools: Ensure information delivered from Development is accurately maintained in digital tools like COMET SAP, MES, and DeltaV.
* Manage New Program Introduction Schedule: Oversee the execution of tasks on schedule and right-first time.
* Develop Process Descriptions: Create process descriptions, process models, facility fits, and other TT-related documents for continuous and fed-batch processes.
* Support Design Implementation: Contribute to the design and implementation of best practices in TT.
* Create Documents: Write, maintain BOMs, EBRs, gBMRs, SOPs/WIs, and ensure accuracy and compliance.
To be considered for this role, the selected candidate must possess:
* Education: Bachelor or Master degree in a relevant field (Science/Technical).
* Work Experience: 3-5 years of work experience in the pharmaceutical or biotech industry, preferably in DS Manufacturing with single-use systems.
* Knowledge and Skills: Familiarity with Unit Operations for mAb manufacturing, experience issuing/transcribing information into required documents, and working knowledge of cGMP regulations.
* Language Proficiency: Fluent English is mandatory; German is an advantage.
The selected candidate will be part of a multidisciplinary team and contribute to the development of novel biopharmaceuticals.