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Employers

Functional Lead/ Lab Head, Basel

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Location:

Basel, Switzerland 

Job Category:

Healthcare

Salary:

€60.40 - €61.40
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Job Reference:

CR/105816_1623138979

Job Views:

36

Posted:

08.06.2021

Expiry Date:

23.07.2021
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Job Description:

Position Purpose:
BDSS QC Bioanalytics is responsible for bioanalytical testing of Biopharmaceuticals for late-phase development projects and commercial products. Applied analytical techniques are mainly cell-based potency assays for bioactivity determination and ELISA /qPCR for the determination of process-related impurities (e.g. host-cell proteins (HCP), residual Protein A, residual DNA).

Major Accountabilities of the role as Functional Lead include:

• Supervision of routine QC testing activities, including line unit approval of analytical records and raw data, investigations of deviations, OOE/OOS, and analytical changes
• Full compliance with regulatory and cGMP guidelines within the field of responsibility
• Support of technical project teams as analytical expert
• Performance of method validations (full ICH validation) and transfers, author of validation- and transfer protocols / -reports
• Trending and evaluation of analytical data
• Method lifecycle management for commercial products including method updates, post-approval changes, or troubleshooting
• Management and coordination of internal and external customer interfaces (e.g. testing/resource requirements, setup of service level agreements)
• Support in health authority inspections as subject matter expert (e.g. routine GMP inspections, pre-approval inspections)
• System owner of laboratory equipment and computerized systems including initial qualification and periodic maintenance/functional testing

Requirements:

• PhD or equivalent education in Biology, Biochemistry, Chemistry, or related discipline
• Several years of experience in analytics / quality control in a leadership role. Experience with Biopharmaceuticals desirable
• Thorough knowledge of GMP requirements
• Good knowledge of instrument qualification, quality metrics
• Experience in audits or inspections from HA
• Very good communication and presentation skills
• Fluent English required (oral & written); good skills in German and/or French as local site language (oral) desired

Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Company Info
Michael Bailey Associates
12 Brook House, Chapel Place
London, United Kingdom
Phone: 00442077392022
Web Site: http://www.michaelbaileyassociates.com
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