Principal Scientist, Formulation Development (Protein formulation _ Biotech)
Kelly Scientific is looking for a Principal Scientist, Formulation Development
- Manage formulation development team including overseeing professional development, education, coaching and training, with continuous focus on improving the working processes.
- Develop novel formulations (liquid, lyophilized, high concentration etc)
- Develop and optimize processes (UFDF concentration, Lyophilization)
- Interact with CMOs for drug product manufacturing during different phases of product development.
- Prepare documentation and operational input to facilitate IMP management for clinical trials
- Manage formulation and forced-degradation studies.
- Manage long-term stability studies.
- Oversee day-to-day laboratory management.
- Responsible for technology transfer from the formulation development group to external CMOs.
- Manage technology assessment and development studies appropriate for company’s formulation development needs.
- Interpret and report results of work carried out in written and oral format both internally and externally.
- Evaluate external developments in the area of formulation development and make recommendations based on their applicability for company’s projects.
- Perform other relevant duties as required.
- PhDin analytical, pharmaceutical, chemistry or biochemistry with at least 3 years of industrial experienceor MScor equivalent in analytical, pharmaceutical, chemistry or biochemistry with at least 6 years industrial experience
- Experience with monoclonal antibodies
- Significant experience in protein formulation for both early and late phase development
- Experience in lyophilization and high concentration formulation development and process optimization
- Experience in technology transfer and management of drug product manufacturing
- Exposure to the principles of QBD (Quality By Design) and DOE (Design of Experiment)
- Ability to manage a team and work independently within the group as well as within teams crossing disciplines and functions
- Fluency in English, both written and verbal; French is a plus
- Excellent communication skills and strong diplomacy skills required
Your contact at Kelly Scientific :
Mme DROMARD Mathilde, Consultant Professional Staffing Life Science and Deputy Manager
Rue du Rhône 114, 1204 Genève, Switzerland