Dr. Reddy’s Laboratories Ltd. Hiring for Team Member – Process Development

Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Major therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infective. Major markets include India, USA, Russia-CIS and Europe apart from other select geographies within Emerging Markets.

Job Title – Team Member – Process Development (oral Solids) – Ipdo, Bachupally

No.of.Openings – 03

Experience – 3 – 6 Years

Location : Hyderabad(Bachupally)

Job Description:

Key Responsibilities:

• To work along with HPT for development of robust and scalable product.
• Participation in early stage of product development to build Processability.
• Carry out process DoE and derive suitable process parameter ranges.
• Carry out risk assessment to identify the impact of Critical process parameters and Critical material attributes on Critical quality attributes.
• Work out control strategies for mitigating identified risks in process.
• Application of scientific and engineering principles to develop process understanding and scale up product from laboratory to commercial scale (Scale up Correlation for all unit operations).
• Designing sampling plan for trial, Confirmatory and Submission batches.
• Execution of Trial, Confirmatory, Exhibit batches and monitoring stability data of the product.
• Preparation and Review of Confirmatory, Hold time, Stability and Submission batch Protocols/Reports.
• Participate / Investigate OOTs, OOSs, Incidents and Deviations and identify the root causes using investigational tools and propose the corrective action and preventive action plan
• Preparation, Review and Recommendations for Process Optimization Report.
• Deficiency response for all geography within the stipulated timeline.
• Knowledge of various regulatory guidelines and cGMP norms pertaining to Oral Solid Dosage forms.
• To provide support for conducting trials for evaluating New Technologies/ PAT Tools for better process understanding.
  
  

• Good knowledge on Process development of Solid oral dosage form; Optimization and application of Scale-up rationale.
• Technical understanding/Sound knowledge on Equipments and Process.
• Knowledge on statistics for data analysis and data representation by statistical methods on submission batches.
• Good analytical and problem solving skills.
• Good inter personal skills and ability to collaborate with CFTs.
• Good communication skills, with high energy and ability to influence and persuade others.
• Focuse on continuous improvement, quality and safety aspects.
  

Educational Qualification & Experience Required: M Pharmacy with 3-6 years experience in Process Development, Formulation development and Technology Transfer – OSD.

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