Senior Analytical Scientist

Senior Analytical Scientist



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 a strong expertise on Drug Substance and powder.

Responsibilities:


• Support 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 (ICH Q8, ICH Q11)
• Contribute to/or realize the conception, design, and interpretation of scientific and technical data to support projects decision making
• Apply broad and deep analytical knowledge and experience to the analytical development and characterization of drug substances and powder (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), quantification of API and impurities (HPLC, GC…)
• Design stability program in close cooperation with Internal Experts (e.g. CMC Development Expert, Head of Formulation and Process Development, Head of Chemical Development) and external partners
• Apply statistical analysis for interpretation of analytical and stability data, set the shelf life and storage conditions of drug substances
• Solve complex problems (e.g. deviations, OOS) through collaborations with others
•Create and enhance collaborative and trusting relationships with external partners
• Lead liaison with Operations to prepare, execute and support technical transfer to the late stage of development,
• Support Operations by providing scientific and technical expertise to ensure maintenance of in market products
• Manage to set a risk management table, update it as necessary and escalade in a timely manner any critical risk to the Supervisor
• Contribute to define and execute mitigation and contingency plan
• Plan efficiently activities and ensure strict monitoring of milestones and budget
• Laad and/or approve key documents such as: method development reports, validation protocols/reports, and justification of specifications, stability protocols/reports, shelf life and storage conditions statement and relevant sections of regulatory filings (DMF, IND, IMPD, NDA etc.)
• Write standard operating procedures and working instructions required by the activities
• Manage 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
• Contribute that external partners operate in compliance with Safety, Health and Environment of the company
• Participate to the preparation of audits and inspections, internally or at external partner’ site
• Maintain awareness of cutting-edge and specific technologies in the field of small molecule and ensure knowledge acquisition
• Ensure to implement regional regulatory requirements and guidelines that impact analytical sciences in close cooperation with CMC Development Expert and other functions
• Maintain current awareness of GMP and other regulations, guidance documents
• Contribute to publish/present in high quality journals/conferences in line with the function strategy

Your profile:

  • 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


For more details, please contact Marine Dollat at mdollat@axepta.com



Marine Dollat mdollat@axepta.com

Specialist Pharmaceutical and Medical Device recruiter and headhunter recruiting in Switzerland and France for the provision of Pharma and Medical Device staff including Quality (GCP, GMP, GLP, GxP, Quality System, Quality Engineer, Quality manager, Quality director and VP level), Regulatory Affairs or Production's position. As specialists in the placement of candidates within the Pharmaceutical Industry, our service is thorough, professional and intelligent. In addition to our permanent and contract recruitment services, we provide proactive search campaigns, advertising campaigns and dedicated account management. If you would like to have a confidential discussion regarding your search for staff or your search for a new position please feel free to contact me directly at mdollat@axepta.com