* Globally operating pharmaceutical company
* 18 months with take over option
About Our Client
Our client, an internationally renowned pharmaceutical company is currently looking for a Tech Transfer Support (m/f/d) with experience in USP and DSP available in March for Lucerne area, to join an international team for a period of 18 months.
Depending on the selected candidate's performance and motivation, the possibility of an extension or a permanent take over.
Hybrid work model (2 days HO per week).
Job Description
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
The Successful Applicant
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
* First Project Management experience
* 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
What's on Offer
The selected candidate will be part of a multidisciplinary team and support the development of novel biopharmaceuticals.
Hybrid work model (2 days HO per week).
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