Formulation Development Senior Scientist (Injectables)

Intas

11 - 15 years

10 - 17 Lacs

ahmedabad

Posted:18 hours ago| Platform:

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Skills Required

parenteral formulation development technology transfer qbd formulation sterile injectables injection vaccines ophthalmology

Work Mode

Work from Office

Job Type

Full Time

Job Description

Key Responsibilities:

Formulation Development:

Design and develop formulations for injectable products such as solutions, suspensions, emulsions, lyophilized products, and pre-filled syringes.
Conduct pre-formulation studies, compatibility studies, and stability testing.
Process Optimization:
Define and optimize manufacturing processes for sterile products.
Work on scale-up and validation batches for tech transfer.
Documentation & Compliance:
Prepare and maintain development reports, batch manufacturing records (BMR), and related documentation as per cGMP.
Ensure compliance with ICH, USFDA, EMA, and other regulatory guidelines.
Technology Transfer:
Support technology transfer activities from R&D to production.
Assist in troubleshooting during exhibit and commercial batches.
Cross-Functional Interaction:
Collaborate with Analytical, Regulatory, QA, and Manufacturing teams.
Required Skills & Competencies:
In-depth knowledge of injectable dosage forms and aseptic processing.
Hands-on experience in lyophilization, sterilization techniques, and formulation design.
Familiarity with QbD principles and DoE approach.
Strong understanding of regulatory guidelines (USFDA, EMA, WHO).

Qualification & Experience:

Education:
M. Pharm / PhD in Pharmaceutics or related discipline.
Experience:
10 to 15 years in sterile formulation development.

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