Senior Scientific Associate ADQC / Analytical Development & Technologies

Senior Scientific Associate ADQC / Analytical Development & Technologies

QLS are recruiting for aSenior Scientific Associate Analytical Development & Technologies to join an innovative pharmaceutical company based in Basel on a contract basis for 12 months.

RESPONSIBILITIES AND TASKS :

The main responsibility of the Analytical Development and Technologies (ADT) within ADQC is the development, optimization, verification and conduct of analytical methods for a broad range of techniques such as e.g. :

• HPLC and UPLC and GC with different detection modality (e.g. PDA, FLD, MS).
• HR-MS for assay, purity, related substances, and mutagenic and carcinogenic impurities determination.
• IC for cation and anion determination.
• NMR for structure confirmation / elucidation and for assay and impurity determination.
• Various spectroscopical techniques : FT-IR, Raman, UV / Vis, Color / turbidity of solution.
• Coulometric / Volumetric Karl Fischer for water determination.
• Particle size distribution and shape analysis by laser diffraction and optical microscopy.
• Techniques characterizing APIs with low solubility (e.g. in Amorphous Solid Dispersion).
• Dissolution, Content Uniformity, Content and Related Substances.

Following Responsibilities :

• Development, assessment, optimization, and application of analytical methods applying analytical techniques mentioned above.
• Conduct of release, retest, stability studies, transfer and (pre-) validation analyses.
• Write-up and review of analytical method protocols, reports (e.g. for development).
• Planning and execution of experiments for method development, assessment, optimization, and application.
• Planning, execution and reporting of forced degradation studies.
• Participation in meetings at intra- and inter-departmental level (e.g., CMC, subject specific working groups).
• Proper documentation of all analytical activities through compilation of all analytical testing records (e.g., notebooks, raw data hardcopies).
• Interpretation and documentation of analytical data including results.
• Drafting and review of CoAs and / or Analytical results sheet and SOPs.
• Training of Laboratory personnel.
• Independently designs and executes projects or experiments with hands on involvement.

REQUIRED QUALIFICATIONS AND EXPERIENCE :

• Apprenticeship-, College-, or university-degree or equivalent education in the field of chemistry, biology, biochemistry, pharmacy, or chemical engineering.
• Ideal education and experience : Apprenticeship plus 6-10 years, BSc plus 4-8 years or MSc plus 3-5 years.
• Good knowledge of analytical chemistry with advanced knowledge of sample preparation, analytical instrumentation techniques especially in chromatography, mass spectrometry, and spectroscopy.

Good troubleshooting skills for analytical instrumentation.

• High flexibility, advanced communication, time-management and team-working skills and basic knowledge of QC or GMP.
• Ability to work independently and to take initiative. Life-long learning mindset and strong sense of accountability.
• Proficient in English.
Il y a plus de 30 jours