Company: Dr. Reddy's Laboratories
Post: Formulation Development
Experience: Relevant
Qualification: M.Pharma
Location: Hyderabad
Key Responsibilities:
Formulation Development :
- Monitor the development of robust, effective and bioequivalent drug products in a timely manner adhering to safety and quality standards.
- Participate in discussion with CFT to develop an effective strategy of drug product development, IP, Bio, etc. Participate in discussions with experts and team members and guide the team in different stages of development (pre-formulation studies material characterization, drug-excipient compatibility, etc.), RLD characterization including reverse engineering, formulation designing and optimization, processes designing and scale-up).
- Participate in developing effective risk evaluation and risk mitigation plan for drug product at every stage of development
- Review data generated and participate in discussions with experts to conclude on the prototype(s),
- Participate in strategizing the sourcing of API and raw materials
- Ensure development studies include studies related to regulatory and internal system requirements
- Identify and promote the use of newer concepts like QbD and DoE in drug product development
Regulatory Support
- Integrate all inputs from functional experts to develop regulatory strategy
- Participate and guide the team to develop effective documentation
- Review regulatory documents for submission to RA
Research/ Intellectual Capital Development
- Provide support internally as formulation subject matter expert
- Identify opportunities to strengthen the IP of the company
- Identify areas to develop internal formulation development guidelines
Technical enhancement
- Identify areas of technical improvement in product development and implementing QbD principles etc.
- System improvement by identifying and implementing improvement in SOP and internal guidance
Education & Experience :
- M Pharm/Ph.D. with >12 years of experience, Should have gained experience in end-to-end product development and troubleshooting, having developed at least one complex product (e.g. solid orals - extended-release, etc.) and delivered more than 15 products overall
- Thorough understanding of regulatory path for emerging and Indian markets
- Handled development of products with clinical approaches for different emerging markets
- Practical exposure of handling and delivering launches for the Indian market
- Exposure on soft gelatin capsules, liquid orals, extended-release dosage forms is preferred
- Having experience of at least two products with external manufacturing partners till commercial launches
- Handling of potent and oncology molecules is preferred
- Practical exposure of technical evaluation including strategy identification for new product selection for various emerging markets
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