Analytical Development & Quality Control Manager

  • Salary: CHF 77.96 - CHF 86.44 ph all-in
  • REF Number: 00056539
  • Consultant: Adrien Guimard
  • Contact: 0041 (0) 800 106 106
  • Date Published: 25.01.2024
  • Closed Date: 24.04.2024
  • Industry:
  • Location: Basel
  • Functional Expertise:

QLS are recruiting for a Manager Analytical Development & Quality Control to join an Innovative Pharmaceutical Company based in Basel on a one year contract basis.

The ADQC manager’s main responsibilities:

  • Expertise in vaccines, large molecules or antibody drug conjugate.
  • Responsible for a project portfolio of up to 4 small projects (typically up to phase 2) or 1-2 highly complex or late stage projects (typically phase 3 and commercial).
  • Follow the processes defined in Guidelines and SOP’s.
  • Development, optimization and implementation of analytical methods, e.g., for purity-, stability-, cleaning verification/validation-, excipients-, content-
  • Representation of AD/QC in technical project team and CMC team meetings• Conduct of release, retest, stability studies, transfer and validation analyses.
  • Proper documentation of all analytical activities according to Good Documentation Practices through compilation of all analytical testing records (e.g., notebooks, raw data hardcopies).
  • Review, interpretation and documentation of analytical data including results from method development, release, retest, validation, stability, and transfer.
  • Write-up and review of analytical protocols and reports and establish specifications.
  • Assurance of adequate maintenance and operation of analytical equipment according to GMP.
  • Independently designs and executes projects or experiments with hands on involvement.
  • Independently reviews scientific workin project related activities.
  • Contact for 3rd parties, e.g., CMOs and CROs, for defined analytical tasks.
  • Leverages workload of respective project members to assure timelines and budget are met.
  • Establishment of source documents for IND, IMPD, and NDA/MA submissions as well as responding to agency questions and together with Technical regulatory colleagues interact with Health Authorities and review CMC sections for IND/IMPD and NDA/MAA filings
  • Design and lead laboratory work to support product or process troubleshooting, special investigations, deviations, change requests, CAPA, product complaints and other analytical tasks independently.
  • Responsible for the analytical expertise for defined Idorsia drug substances and/or drug products
  • Manage the outsourcing of analytical activities to CROs/CMOs in a compliant way including supplier selection input.
  • Participate in technology transfer between laboratories, both internal and external to the company.

Candidate’s Requirements:

  • In addition to knowledge of the GMP/regulatory requirements, a strong background in analytical chemistry is required
  • Broad knowledge in analytical chemistry. Basic knowledge in synthetic chemistry, drug substance processing and/or formulation development, pharmaceutical processing with a deep understanding of pharmaceutical sciences related to drug substance or product development
  • Experience in the development and performance of analytical tests for a varietyof drug substance and prodcut
  • Personality and disposition to manage professionals effectively in a matrix system
  • High flexibility, superior communication, time-management and team-working skills
  • Proficient in English. Life-long learning mindset and a strong sense of accountability
  • Should actively seek for technical and scientific solutions to improve quality and productivity
  • Strong skills in timeline development and management


For more information or to applyfor this position, please contact Adrien on 0041 (0) 800 106 106 or email Please could you send any correspondence in English. Please quote job reference 56539 in all correspondence.

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