(Senior) Scientific Associate in ADQC

QLS are recruiting for a Scientific Associate in Analytical development and QC to join an innovative pharmaceutical company based in Basel, on a contract basis for one year.

Analytical Development / Quality Control (AD/QC) is dealing with the analytical development of Drug Substance (DS) and Drug Product (DP). AD/QC must ensure that products are delivered according to quality standards defined during development and in compliance with GMP and regulatory guidelines. 

RESPONSIBILITIES AND TASKS:

• Development, optimization and application of analytical methods, e.g., for purity-, stability-, content-and potentially genotoxic impurity determinations. 
• Write-up of analytical methods for implementation. 
• Conduct of release, retest, stability studies, transfer and validation analyses. 
• Proper documentation of all analytical activities according to Good Documentation Practices.
• Interpretation and documentation of analytical data including results from method development, release, retest, validation, stability, and transfer. 
• Write-up of analytical protocols and reports, e.g., for validation and stability studies. 
• Assurance of adequate maintenance and operation of analytical equipment according to GMP. 
• Drafting and review of CoAs and/or Analytical results sheet. 
• Drafting of SOPs, GUIs, TPLs, FRMs. 
• Training of Laboratory personnel. 
• Ensuring of cleanliness of laboratory and work space. 
• Independently designs and executes projects or experiments with hands on involvement. 
• Independently reviews scientific work in project related activities. 
• Ensures availability of adequate lab materials as well as justifies acquisition of new materials or equipment.

• Apprenticeship-, College-, or university-degree or equivalent education in the field of chemistry, biology, biochemistry, pharmacy, or chemical engineering, with 3 - 5 years experience.
• MS experience. Ability to efficiently plan, 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 troubleshooting skills for analytical analyses. Good knowledge of GMP. High flexibility, advanced communication, time-management and team-working skills. 
• Experience in dissolution testing is a must.
• Good knowledge of Empower software.
• Ability to work independently and to take initiative. Life-long learning mindset and strong sense of accountability. 
• Should actively seek for technical solutions to improve quality and productivity. 
• Proficient in English. 

Please could you send any correspondence in English. Please quote job reference 99285 in all correspondence.