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Functional Lead-Lab Head

Michael Bailey Associates - UK Contracts

Posted on Jul 14, 2021 by Michael Bailey Associates - UK Contracts

Basel, Switzerland
Research
14 Jul 2021
£60.4 - £61.4 Daily
Contract/Project


Functional Lead-Lab Head

We are looking for a motivated functional lead to supervise the performance of bioanalytical experiments (ie cell-based bioassays, ELISA and Q-PCR) for quality control (release, stability, and in-process control (IPC) testing) of biotech drug substances (DS) and drug products (DP) in collaboration with members of the own and cross-functional teams in a cGMP environment. Analytical method validation and transfers will be a major part of the position.

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 life cycle management for commercial products including method updates, post-approval changes, or troubleshooting
. Management and coordination of internal and external customer interfaces (eg testing/resource requirements, setup of service level agreements)
. Support in health authority inspections as subject matter expert (eg 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
. Results oriented, team player and able to work with all levels of the organization
. Strong leadership and problem solving skills. Able to identify issues and develop business-friendly solutions in line with the overall compliance
. 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.




Reference: 1254688568

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