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Principal Scientific Associate

Switzerland   •  Contract/Temporary, Full time

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 laboratory activities. 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 analytical methods 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 of qualification 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 accomplish product 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 chemical engineering
? 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

Please could you send any correspondence in English. Please quote reference 51564 in all correspondence.

You MUST be eligible to work in Switzerland. Learn more

  • Agency: CK Group
  • Contact: Adrien Guimard
  • Phone: 01438 723 500
  • Reference: 51564
  • Updated: 15th September 2021
  • Expires: 13th October 2021

CK Group

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