Principal Scientific Associate

  • Salary: Competitive
  • REF Number: 00051564
  • Consultant: Adrien Guimard
  • Contact: 0041 (0) 800 106 106
  • Date Published: 15.09.2021
  • Sector: Basel Area
  • Location: Pratteln, Experienced
  • Discipline: Science - Analytical Chemistry

QLS are recruiting for a Principal Scientific Associate to join an important project with an Innovative Pharmaceutical Company at their site based in Allschwil on a contract basis for one year.

Main responsibilities:

  • Organization of laboratoryactivities. 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
  • Write-up of analyticalmethods for implementation
  • Participation and collaboration in meetings at intra- and inter-departmental level(e.g., CMC)
  • Conduct of release, retest, stability studies, transfer and validation analyses
  • Proper documentation of all analytical activities according to Good Documentation Practices
  • Review, interpretation and documentation of analytical data
  • Write-up and review of analytical protocols, reports and specifications
  • Assurance of adequate maintenance and operation of analytical equipment according to GMP
  • Drafting and review of CoAs and Analytical results sheets, specs ,SOPs, GUIs, TPLs and FRMs
  • Organization of GMP-(re)qualification and validation of analytical equipment with external companies
  • Elaboration ofqualification plans and review of qualification documents
  • Training of Laboratory personnel on advanced tasks and GMP regulations
  • Independently designs and executes projects or experiments with hands on involvement
  • Independently reviews scientific work in project related activities

Further responsibilities include:

  • Ensures availability of adequate lab materials and justifies acquisition of new materials or equipment
  • Ensuring of cleanliness of laboratory and workspace
  • Contact for 3rd parties, e.g., CMOs and CROs for defined analytical tasks
  • Independent evaluation and development of novel analytical techniques and instrumentation
  • Leverages workload of respective project members to assure timelines and budget are met
  • Review CMC sections for INDP/IMPD and NDA/MAA filings
  • Design and perform laboratory work to support product or process troubleshooting, special investigations, CAPA and product complaints with minimal supervision
  • Set and accomplishproduct development timelines working closely with formulation scientist

Candidate’s Requirements:

  • Apprenticeship-, College-, or university-degree or equivalent education in the field of chemistry, biology, biochemistry, pharmacy, or chemicalengineering
  • Apprenticeship 11+ years, BS 9+ years or MS 6+ years or PHD 0-2 years ‘experience
  • Ability to efficiently plan and effectively execute and document analytical experiments in a GMP-compliant pharmaceutical environment
  • Good knowledge of analytical chemistry with advanced knowledge of sample preparation, HPLC and spectroscopic instrumentation
  • Good trouble-shooting skills for analytical analyses
  • Good knowledge of GMP
  • Ability to work independently and to take initiative
  • Should actively seek for technical solutions to improve quality and productivity
  • Proficient in English

For more information or to apply for 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 reference 51564 in all correspondence.

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