Principal Scientific Associate

Job content

• 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.