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
  • 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

Apply:

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

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