Formulation Development Scientific Leader

5 - 7 years experience  • 

Salary depends on experience
Posted on 03/21/18
5 - 7 years experience
Salary depends on experience
Posted on 03/21/18

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

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