In this role, the candidate would be supporting New Product Introduction, while also acting as a key contributor to the evolving site tech transfer strategy.
While bringing energy, knowledge, and innovative ideas, the candidate will be responsible for performing the following tasks :
* Supporting the development of the tech transfer program
* Collaborating 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)
* Maintaining and feeding information delivered from Development in different digital tools such as COMET SAP, MES, and DeltaV
* Managing new program introduction schedule to ensure tasks are executed on schedule and right-first time
* Supporting development of process descriptions, process models, facility fits, and other TT -related documents for continuous and fed-batch processes
* Supporting design and implementation of best practices in TT
* Writing, maintaining of BOM's and EBR's (Paper), gBMR (MES) and SOPs / WI's
In order to be considered for the role, the selected candidate must have :
* Bachelor or Master degree in a relevant field (Science / Technical)
* 3-5 years of work experience in the pharmaceutical or biotech industry (ideally in DS Manufacturing with single-use system)
* Familiarity with Unit Operations for mAb manufacturing
* Experience in issuing and transcribing information into documents required for manufacturing such as BOM, Batch Sheets and DeltaV
* Experience in the use of automated / digital systems such as DeltaV, MES, eVal, SAP COMET
* Working knowledge of cGMP regulations (certification is not enough)
* Understanding of the general principles of New Product Introduction (Tech Transfer)
* 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.
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