Manager (Formulation & Development)

Evolet Healthcare

12 - 15 years

12 - 15 Lacs

Gurugram

Posted:1 day ago| Platform:

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Skills Required

Formulation Development RS Oral Solid Dosage Analytical Data Review Team Leadership Parenteral Formulations Bioequivalent Product Development Dissolution Regulatory Submissions Assay Quality by Design Technology Transfer Stability Studies

Work Mode

Work from Office

Job Type

Full Time

Job Description

OBJECTIVE:

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.

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