Biocon - Deputy General Manager - Analytical Development - Complex Injectables

Key Responsibilities :

- The candidate should have worked in the area of analytical method development of complex injectable formulations [Generic & 505(b)(2)] for North America, EU and other regulated markets.

- The candidate should have experience of developing analytical methods and validation for formulations including microspheres, in-situ depot formulations, injectable suspensions, liposomes, nanoparticles, peptides and lyophilized products

- Proficient in development, validation of analytical methods by various instrumental techniques to support the formulation product developments for regulatory dossier submissions

- Experienced in analytical development & characterization, evaluation interpretation through below techniques:

- Versatile chromatographic techniques (SEC, IEC etc)

- Peptide mapping, finger printing & characterization

- LC MS/MS, HRMS etc

- NMR, Raman and other spectroscopic techniques

- Experienced in analytical characterization of peptides, complex molecules and non-conventional dosage forms.

- Candidate should have demonstrated leadership skills to handle analytical development team for support of product delivery

- To handle procurement, installation & qualification of analytical equipment to set up and maintain a GLP compliant analytical testing lab.

- Comprehensive understanding of USFDA, EMA, MHRA, and ICH guidelines, and the regulatory requirements of various International Regulatory Agencies

Experience & Qualification :

- 13+ years experience in handling complex injectable analytical method development and other generic injectable products

- M.Pharm/PhD in Pharmaceutical Sciences from reputed institutes

- Management and Customer Service experience Strong administrative skills

- Demonstrated ability to lead

- Strong communications skills