Research Associate

Job Description:

1. Formulation & Development of Injectable Drug Delivery Systems

   Should be able to perform the below activities Involving

   1. Literature Search involving reading relevant product-related patents, research articles & regulatory recommendations & guidelines.
   2. Based on the literature proposing strategy and planning batches
   3. Sourcing of raw materials & excipients as per requirement & specification from approved vendors.
   4. Planning of Lab batches, stability batches, and biostudy batches.
   5. Scaling up (Technology transfer) of lab batches at our production facilities or third-party manufacturing sites.
   6. Active involvement in planning preclinical & clinical Studies.
   7. Documenting as per good documentation practice, Product register completion, documenting critical things observed during manufacturing, preparation of product development reports, and dossiers for product registration. Compilation of all lab batch analytical data and presenting them.    
   8. All other duties as and when assigned by the superior.
   Good Technical knowledge about all the excipients used in the formulation of Injectables, their application, and rational use.
2. Good technical as well as practical experience in the development of Liposomal drug delivery systems and Control release depot Injection (microspheres technology) and other novel drug delivery systems.
3. Sound regulatory knowledge for product development and registration in USFDA.
4. Well acquainted with GMP and ICH guidelines required for generic drug development. 
5. Well acquainted with QbD techniques and use of Design Expert software-crucial tool in pharmaceutical development

Good knowledge about Lyophilisation and creating new recipes for specific products