This fast-growing global pharmaceutical company is looking for a scientific leader in Analytical Development that is eager to elevate their career to the next level!
- Analytical methods for various internal and external projects (new and commercialized) products in support of process analytical technologies (PAT) for commercial manufacturing processes.
- Independent development and validation of analytical test methods for APIs, excipients, and drug products using industry standard methodologies
- QbD principles for analytical methods; Following US FDA, USP, ICH guidelines.
- Evaluate/study/qualify new vendors for suitability based on physico-chemical properties
- Conduct characterization studies and analysis of material in the laboratory.
- Lead analysis of samples for various R&D and GMP stability studies.
- Draft protocols, reports, technical memos
- Oversee and manage CROs/CDMOs)
- Train peers and junior staff members on new techniques.
- Doctorate in Analytical Chemistry, (or relevant study) with 3+ years of relevant experience or Masters 5+ years .
- In-depth understanding of analytical methods, theoretical principles of laboratory analytical techniques such as UV-Vis, Liquid Chromatography (LC), Gas Chromatography (GC) and Spectroscopy techniques are a MUST
- Dissolution, Particle Size Analysis, dynamic vapor sorption (DVS), x-ray powder diffraction (XRPD), mass spectrometry (MS), nuclear magnetic resonance (NMR) etc. is a PLUS.
- strong communication and technical writing skills concerning scientific principals
- computer skills and software applications such as Microsoft Office tools.