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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