DNS has an opportunity for an experienced candidate to perform analytical activities in support of DNS’ small molecule drug substances (NCEs) and drug products in clinical development. This position will work closely with external contract manufacturing and testing organizations and with internal Process Chemistry and Formulation Development functions. The specific skills and responsibilities include:
• Perform analytical activities for small molecule drug substances and drug products according to regulatory requirements for investigational products.
• Develop and transfer in-house developed analytical methods to external contract organizations.
• Manage analytical activities at external contract organizations and provide support during the manufacturing campaigns for drug substances and drug products
• Provide analytical support for internal Process Chemistry and Formulation functions.
• Maintain proper documentation of laboratory experiments.
• Author internal analytical reports in support of regulatory filings and review analytical documents and data generated by external contract organizations.
• Participate in technical visits and audits to external contract organizations.
• M.S. or Ph.D. in Pharmaceutical Sciences, Chemistry, or related fields with a minimum 3 years of hands-on experience in performing analytical development and testing activities in the pharmaceutical industry.
• Experience with analytical method development and validation for small molecule drug substances (NCEs) and drug products is a must.
• Strong proficiency with UPLC, HPLC, GC, Dissolution, and solid state characterization (e.g. DSC, TGA, XRPD) instrumentation.
• Knowledge of the CMC regulatory requirements (e.g. FDA, EMEA, and ICH) and thorough understanding of working in a cGMP environment is highly desirable.
• Excellent oral and written communication skills.
• Strong technical, project management, and interpersonal skills.
• Ability to work independently using critical and creative thinking skills to solve problems and advance the development objectives of the company.
• May require up to 15% travelling.