Analytical Development Specialist - PSD >> Dr. Reddy's Laboratories Company Location Hyderabad
Purpose :
This role will work as subject matter expert (SME) on particle characterization; Particle Size Distribution (PSD) characterization involving Laser Diffraction, Dynamic Light Scattering, G3 and PAT sizing tools; Ensure end to end product support in terms of method development (MD), method verification, method validation, online and in line particle characterization for process optimization, customer query & regulatory support in the domain of particle characterization; monitor transfer methods to facilitate smooth technology transfer and support ANDA/ DMF filing of new products ; provide inputs to the AR&D lead & suggest improvements in the existing process.
Key Responsibilities:
Method Development & Validation
- Design PSD strategy to meet the innovation challenge for products especially Ophthalmic and assess method robustness in the light of QbD to strengthen method design.
- Interpret data and troubleshoot anticipated problems in the course of development and validation within particle characterization domain through relevant mitigation plans/alternative strategies.
- Extend the PSD MD support on Malvern Mastersizer 2000 & 3000, Dynamic Light Scattering and Morphology G3 analyse. Resolve & troubleshoot customers / vendors methods wherever necessary to ensure more robust DRL methods are in place.
- To write Method development reports, review PSD data in terms of adequacy and quality.
Product Characterization & Sameness
- Identify and execute the characterization startegies for complex generics, collaborate with external experts to develop methods where facility is not available in house. Extend a complete end to end support for particle characterization across the product range by designing strategies for API, in process and FP drug forms from both analytical as well as process stand point. Design regulatory strategy for characterization along with R&D and regulatory teams to show pharmaceutical equivalence for faster approval. Identify and interpret data trends in sample analysis
Regulatory Support
- Review complex queries from regulatory authorities/customers related to API and formulations
- Respond to complex deficiencies related to PSD and wherever necessary bolster the response with adequate data from orthogonal analytical techniques.
- Anticipate potential queries from regulatory authorities/customers a forehand and propose relevant measures to address the same
New Technologies- Leveraging PAT tools for robust in-process support
- Build capabilities for particle characterization that helps process optimization.
- Evaluate new technologies for PAT tools for application in projects to meet the new challenges/ requirements.
- Evaluate new technologies for simplification of existing methods for faster analysis & results.
Education & Experience :
Ph D in Physical Chemistry/Materials Science/Pharmaceutical Science with 4 - 6 years of experience
Strong Technical expertise in particle science - Characterization of various particulate drug forms - API, in process and finished products. Good understanding of particle engineering - top down and bottoms up for particle size control. Experience in having designed analytical strategy for product development;
Seniority Level
Mid-Senior level
Industry
- Pharmaceuticals
Employment Type
Full-time
Job Functions
- Research
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