Principal Scientific Associate
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.
