Senior Analytical Scientist Oral and Topical Form
My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their Analytical team in Switzerland, Vaud Canton.
Due to this growth my client is looking for a Senior Analytical Scientist with experience working on Oral and Topical forms.
- Contribute to design and oversee Small Molecule, oral and topical, analytical development plan and stability programs, any applicable regulatory requirements.
- Contribute to design and oversee scientific studies in support of technical programs as they progress from early development into confirmatory development, technology transfer up to the registration and to support as needed manufacturing process at the commercial site.
- Outsourcing of key activities such as drug substance characterization, method development/optimization/validation/transfer, proposing specification and analytical control strategies, recommending stability programs.
- Design stability program in close cooperation with Internal Experts and external partners
- Contribute to analytical development plan and stability program for primarily Drug Substance and possibly Drug Product in cooperation with external partner and internal experts, in line with business priorities, following a Quality by Design framework
- Solve complex problems (e.g. deviations, OOS) through collaborations with others
- Review, author and approve key documents such as method development reports, validation protocols/reports, and justification of specifications, stability protocols/reports and relevant sections of regulatory filings (DMF, IND, IMPD, NDA etc.)
- Apply broad and deep analytical knowledge and experience to the analytical development and characterization of drug substances and powder
- Ensure close oversight of GMP activities that are conducted externally to ensure at each stage of development an appropriate level of quality requirements and report in a timely manner any major or critical issue
- Maintain awareness of cutting-edge and specific technologies in the field of small molecule and ensure knowledge acquisition
- PhD with 5 years of working experience or MS with 15 years of working experience in Chemistry, Analytical Chemistry, Pharmaceutical Sciences or closely related to the field
- Strong track record of success with oral and topical developments
- Experience working with external partners (e.g. CDMO, CRO, Academic)
- In-depth scientific knowledge and experience in developing and validating analytical methods, covering different technics and methods (e.g. microscopy (SEM, TEM, SEM-EDX, ATR-FTIR), spectroscopy (FTIR, Raman, confocal RAMAN, UV-vis), laser scattering and solid-state characterization techniques (XRPD, DSC, TGA, ITC), powder rheology, surface area determination by BET, particle size and particle shape and morphology techniques
- Solid understanding of characterization, technology transfer and troubleshooting when it comes to drug substances (Oral and Topical)
- Fluency in English, both spoken and written, any other language an asset
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