Research Associate - Formulation R&D (Sterile)

Difgen Pharmaceuticals; Hyderabad; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Difgen Pharmaceuticals in Hyderabad is seeking a Research Associate Formulation R&D (Sterile) with hands-on experience in sterile dosage forms, including injectables and ophthalmics. You will develop, optimize and scale sterile formulations, while aligning with QbD and GLP principles.

Responsibilities include literature interpretation, technology transfer, documentation and multi-batch development work to support regulatory submissions and product launch readiness.

Qualifications

• Strong knowledge of sterile formulation development.
• Hands-on experience in injectables and/or ophthalmic formulations.
• Experience in pre-formulation, formulation optimization, scale-up and exhibit batches.
• Knowledge of QbD, GLP and pharmaceutical development principles.
• Good documentation and scientific report-writing skills.
• Ability to interpret scientific literature and analyze formulation development data.
• Experience in technology transfer and preparation of development documentation.

Responsibilities

• Develop and execute assigned projects for sterile formulations, including simple and complex injectables and ophthalmics.
• Identify project requirements and coordinate indenting, receipt, consumption and monitoring of raw materials, packing materials and consumables.
• Ensure cleanliness, equipment verification and calibration status, along with timely resolution of identified issues.
• Prepare SOPs for new equipment and procedures and review existing SOPs for mandatory revisions.
• Review and interpret scientific literature to support formulation development and project decisions.
• Conduct literature surveys, pharmaceutical equivalence and pre-formulation studies during product development.
• Plan and execute laboratory-scale batches and optimization batches for formulation development.
• Develop and optimize drug formulations using appropriate technology and scientific principles.
• Conduct and monitor quantitative and qualitative pre-formulation studies for sterile dosage forms.
• Execute scale-up and exhibit batches at the plant level.
• Support product development in compliance with GLP procedures and QbD principles.
• Conduct experiments, analyze data and provide scientific inputs for formulation development.
• Prepare and maintain development batch compilation, stability batch compilation and other relevant documentation.
• Prepare PDR, MFR, specifications, stability protocols, stability reports and other departmental documents.
• Execute technology transfer of finalized F&D products to the manufacturing site along with complete documentation.
• Ensure development of sterile dosage forms in accordance with QTTP and applicable regulatory requirements.
• Perform any other responsibilities assigned by the HOD related to the concerned area.

Skills

Sterile Formulation Development

Injectables

Ophthalmic Formulations

Pre-formulation

Formulation Optimization

Scale-up

Exhibit Batches

QbD

GLP

Documentation & Reporting

Literature Analysis

Technology Transfer

Development Documentation

Job description

We are looking for a Research Associate Formulation R&D (Sterile) with relevant experience in the development and execution of simple and complex sterile formulations, including injectables and ophthalmic products.

Key Responsibilities

• Develop and execute assigned projects for sterile formulations, including simple and complex injectables and ophthalmics.
• Identify project requirements and coordinate the indenting, receipt, consumption and monitoring of raw materials, packing materials and consumables.
• Ensure cleanliness, equipment verification and calibration status, along with timely resolution of identified issues.
• Prepare SOPs for new equipment and procedures and review existing SOPs for mandatory revisions.
• Review and interpret scientific literature to support formulation development and project decisions.
• Conduct literature surveys, pharmaceutical equivalence and pre-formulation studies during product development.
• Plan and execute laboratory-scale batches and optimization batches for formulation development.
• Develop and optimize drug formulations using appropriate technology and scientific principles.
• Conduct and monitor quantitative and qualitative pre-formulation studies for sterile dosage forms.
• Execute scale-up and exhibit batches at the plant level.
• Support product development in compliance with GLP procedures and QbD principles.
• Conduct experiments, analyze data and provide scientific inputs for formulation development.
• Prepare and maintain development batch compilation, stability batch compilation and other relevant documentation.
• Prepare PDR, MFR, specifications, stability protocols, stability reports and other departmental documents.
• Execute technology transfer of finalized F&D products to the manufacturing site along with complete documentation.
• Ensure development of sterile dosage forms in accordance with QTTP and applicable regulatory requirements.
• Perform any other responsibilities assigned by the HOD related to the concerned area.

Required Skills

• Strong knowledge of Sterile Formulation Development.
• Hands-on experience in Injectables and/or Ophthalmic formulations.
• Experience in pre-formulation, formulation optimization, scale-up and exhibit batches.
• Knowledge of QbD, GLP and pharmaceutical development principles.
• Good documentation and scientific report-writing skills.
• Ability to interpret scientific literature and analyze formulation development data.
• Experience in technology transfer and preparation of development documentation.