Senior Scientific Associate ADQC / Analytical Development & Technologies
CK Group
Basel, Basel-City
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.
30+ days ago