Formulation Scientist - CMC Ocular Small Molecule

Our client is a privately held biotechnology company in Zurich that is seeking a highly motivated senior scientist to plan and provide strategic options for ocular formulations of small molecules.

They are looking for an energetic and experienced leader with a desire to work in a fast-paced and dynamic international team environment to help build a world class drug discovery company.

The successful candidate will have experience in talking to regulatory for the CMC part and will be asked to provide his or her proven expertise in this field.

Your responsibilities in this exciting role are as follows:

• CMC specialist for ocular formulation for small molecule FOTE/BOTE (front of the eye/back of the eye)

• Strategic formulation/CMC development identification of available options for drug delivery of small molecules

• Identification of contract laboratory and manufacturer

• Overviewing process in contract laboratory and manufacturing development

• CMC regulatory writer: CMC section for IND

• Pre-IND and potentially other regulatory meetings 

The successful candidate brings the following:  

• Track record of consulting services in ophthalmic formulation area

• Led pre-clinical formulation development, pilot operations and manufacturing process and clinical material supply

• Identification of CROs for preclinical/clinical manufacturing, packaging and distribution

• Experience in CMC and pre-clinical documentation and IND/IMPD writing

• Participated and pre-IND meetings with regulatory authorities