Formulation Development Scientific Leader

Andrx Pharmaceuticals   •  

North York, ON

5 - 7 years

Posted 265 days ago

This job is no longer available.

Reporting to the Technical Formulation Development Manager, the Formulation Development Scientific Leader will be responsible for the development and modification of pharmaceutical formulations and manufacturing process in order to obtain a stable and bio-equivalent product. The Formulation Development Scientific Leader is responsible for new products and supports all activities required to develop, optimize and scale-up a stable solid dose formulation to make it suitable for commercial productions.

ADDITIONAL DETAILS

 

  • Research and compile pre-formulation data and patent information on the drugs and excipients used in the formulation project
  • Design, issue and evaluate formulation trials to develop optimized formulas
  • Conduct suitable trials to vary the excipients within SUPAC guidelines
  • Ensure the optimum manufacture of initial pilot, stability, bio and small-scale production batches
  • Prepare Pharmaceutical Development Reports for submitted products as well as required documentation for the regulatory authorities
  • Liaise with the documentation groups for the preparation of a summary of the differences between the bio / stability/ submission masters and the scale-up masters, including components, equipment and process flowchart
  • Assist in the development and design of original formulations

CANDIDATE BACKGROUND

 

  • Masters degree or Ph.D. in Chemistry, Pharmacy or Pharmaceutical Technology, Chemical Engineering or related science
  • Over 5 years of working experience, preferably in a pharmaceutical development environment, with related experience in formulation development of solid dosage forms, scale-up or technology transfer
  • Excellent working and theoretical knowledge of controlled release dosage forms and pharmaceutical dosage form
  • Excellent knowledge of excipients
  • Must have excellent knowledge of GMP, GLP, Safety, FDA and TPD guidelines
  • Exceptional verbal and written communication skills
  • Strong organization and report writing skills