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Major Accountabilities:
- Responsible for developing and validating all analytical methods required for the API, excipients and finished product required for their assigned projects
- Responsible for a wide array of complex technical work needed to develop high quality methods such that products can be formulated, stability tested and can be registered and commercial product tested and released by QC
- Responsible for the timely and successfully hand over of analytical methods to the Stability group, contractors, Process development and QC other development group, QC or external laboratory.
- Provide all required reports to Regulatory for dossier submission and answer any analytical question asked by the regulatory agencies
- Ensure suitable methods for API and innovator evaluation and testing the different formulations produced for pre stability screening
- Work closely with Section Leader, senior associates, other Development Scientists and specialists and Manager, with the stability scientists helping to validate their methods and test API and excipients for stability trials
- Help train and support the method development scientists, organise and coordinate development and validation work , carry out the development process
- Work in the project team environment and work closely with formulation scientist to ensure successful product development
Minimum requirements
- BSc, MSc or PhD in Chemistry, Pharmacy or related field
- More than 5 years experience in a related pharmaceutical area with demonstrated knowledge of the development process analytical method development
- Specialist technical skills in at least one area of pharmaceutical analytical development
- Knowledge in either/or Analytical Chemistry/Pharmaceutical Chemistry/Physical/ Organic
- Highly developed technical problem solving and analytical skills
- Flexibility and ability to respond quickly as well as initiative and a proactive attitude
- Highly logical processing, troubleshooting and decision-making skills
- Strong interpersonal, communication, organization, lead and team-work skills
- An ability to write sound scientific reports
- Fluent in English (oral and written)
- The highest quality work standards supported by proficient use of Microsoft software

source: http://www.novartis.com/careers