Functional Lead / Lab Head (f/m/o) 100%

Peppercorn - talent acquisition. For more than 30 years, we support our clients in the personnel recruitment for fixed and temporary placements. We are a financially independent company within the FAVORIS group.

For an international pharmaceutical company located in Basel we are looking for a:

Functional Lead / Lab Head (f/m/o) 100%

DSS 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).

We are looking for a motivated functional lead / lab head to supervise the performance of bioanalytical experiments (i.e. 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.



Tasks & Responsibilities:

  • 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

 
Ideal Background:
  • 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

Start date: asap
Duration: 3 years (until 30th June 2024)
Work location: Basel
Workload: 100%



 
Interested ?
We look forward to your application via our homepage


Peppercorn Human Experts AG
Auberg 2
4051 Basel


Anja Glinschert
Telefon: 058 255 31 01

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