Manager (Formulation & Development)

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.