Senior Research Associate Evolet Healthcare

4.0 - 7.0 years

4 - 7 Lacs

Gurugram

Work from Office

Job description OBJECTIVE: To maintain optimum quality in Formulation research and generation of quality data in Formulation Development department to support the development of a safe and quality product. RESPONSIBILITY : Formulation development of oral solid, Liquid, Parenteral and semisolid products by QbD Approach for Regulatory & ROW markets. Technical assessments of projects (Screening of Project, pipeline) Scientific literature Search and patents evaluation for strategic development. Technical screening of API, RM, PM sourcing for F&D activity. Formulation Development Strategy preparation with design around opportunities & developing Bio-equivalent products. Provides support and guidance in scale up/Technology transfer activities for new Formulation development Projects Assisting and ensuring timely completion of development activities at in-house R&D lab, (Pre-formulation studies, formulation development, stability studies etc.,) Guiding the F&D teammates to timely complete the development activities. Review and summarizing technical data for milestone assessments. Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality. Responsible for review of analytical data (e.g. dissolution, assay, related substances, Blend uniformity, content uniformity etc.) Supporting regulatory team in health regulatory submission and query response. Maintain Evolet Healthcare Policy on Quality, Safety and Efficacy Value.

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Manager (Formulation & Development) Evolet Healthcare

12.0 - 15.0 years

12 - 15 Lacs

Gurugram

Work from Office

Job Description OBJECTIVE: To maintain optimum quality in Formulation research and generation of quality data in Formulation Development department to support the development of a safe and quality product. RESPONSIBILITY : Formulation development of oral solid, Liquid, Parenteral and semisolid products by QbD Approach for Regulatory & ROW markets. To handle a team of 10 to 15 team members. Technical assessments of projects (Screening of Project, pipeline) Scientific literature Search and patents evaluation for strategic development. Technical screening of API, RM, PM sourcing for F&D activity. Formulation Development Strategy preparation with design around opportunities & developing Bio-equivalent products. Provides support and guidance in scale up/Technology transfer activities for new Formulation development Projects Assisting and ensuring timely completion of development activities at in-house R&D lab, (Pre-formulation studies, formulation development, stability studies etc.,) Guiding the F&D teammates to timely complete the development activities. Review and summarizing technical data for milestone assessments. Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality. Responsible for review of analytical data (e.g. dissolution, assay, related substances, Blend uniformity, content uniformity etc.) Supporting regulatory team in health regulatory submission and query response. Maintain Evolet Healthcare Policy on Quality, Safety and Efficacy Value.

Posted 1 month ago

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