For our Oligonucleotide Production Center in Cincinnati/Ohio, USA, we are looking for a Manger, Analytical Development.

Responsibilities:

• Sets objectives for team and documents success of team.
  
• Conducts regular performance reviews of Analytical Development associates, making recommendations for promotions, new hires and terminations, and arbitrates personnel conflicts.
  
• Maintain effective communication with the other Girindus departments, project teams, and clients.
  
• Provides analytical support to Oligonucleotide Process Development and Small Molecules departments including the resolution of synthesis or scale-up problems and the development of in-process controls.
  
• Oversees and participates in the development, qualification, and validation of methods for the chemical and physical testing of raw materials, in-process intermediates, and final drug substance.
  
• Writes and/or reviews and approves method validation protocols/reports, and method transfer protocols/reports in accordance with ICH guidelines and Girindus policy.
  
• Responsible for laboratory OOS investigations, troubleshooting of analytical problems, and technology transfer of analytical methods for new and existing drug substances to other laboratories.
  
• Participates in cGMP training, safety programs, instrument audit programs, and maintains an orderly and safe laboratory environment.
  
• Oversees the documentation and reporting of results in technical reports.
  

Qualifications: PhD degree with concentration in Analytical Chemistry with 5+ years of experience or BS/MS with 10+ years of experience in developing and validating various analytical techniques. Team-leader or managerial experience. High level of knowledge and hands on experience in various analytical techniques, especially chromatographic techniques (UPLC and HPLC) and mass spectrometry (LC/MS). Knowledgeable in cGMPs to assure compliance of the Analytical laboratory with FDA, ICH Q7 guidelines, and Girindus policy. Experience with oligonucleotide synthesis or analysis is a plus.

Girindus is an Equal Opportunity Employer.