Research Associate

Vizen Life Sciences Pvt Ltd; Hyderabad; On-site; INR 37,878,788 - 66,287,879; Full time

Job summary

DifGen Pharmaceuticals in Hyderabad is looking for a professional in pharmaceutical development focusing on sterile formulations. The candidate will handle project requirements, equipment maintenance, and documentation while ensuring compliance with GLP standards.

Ideal applicants should possess an M. Pharm degree and have 3 to 5 years of relevant experience in formulating injectables and ophthalmics. A strong commitment to quality and a scientific approach to problem-solving are essential.

Qualifications

• Experience of 3 to 5 years in sterile formulations including injectables and ophthalmics.
• Ability to prepare Standard Operating Procedures (SOPs) and documentation.

Responsibilities

• Identify project requirements and monitor raw material consumption.
• Execute cleanliness and calibration status of equipment.
• Prepare SOPs for new equipment and review existing SOPs.
• Develop new formulation projects complying with GLP procedures.
• Conduct experiments to support product development.

Skills

Sterile formulations development

Quality by Design (QbD)

Scientific literature review

Education

M. Pharm graduate

Job description

Job Details

Job Location: Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072

Salary Range: $400,000.00 - $700,000.00 Salary/year

Job Shift: Any

Responsibilities

• Identify project requirements and request for indenting, monitor receipt, consumption of raw materials, packing materials, consumables, etc.
• Execute cleanliness, verification, calibration status of equipment along with resolution action plan on a daily basis.
• Prepare SOPs for new equipment and procedures & review of SOP for mandatory revision.
• Review and interpret scientific literature to guide project decisions.
• Develop new formulation projects by complying GLP procedures.
• Carry out literature survey, pharma equivalence and pre-formulation study during product development; plan & perform experiments for various lab scale batches, optimization batches.
• Execute scale up and exhibit batches at plant level.
• Preparation & maintain development batch compilation, stability batch compilation and other documentation during development.
• Prepare PDR, MFR, specifications, stability protocol, stability report and relevant departmental documents.
• Carry out & execute technology transfer of finalized F & D product along with its complete documentation to site of manufacturing.
• Carry out any task requested by HOD in area of concern.
• Responsible for development of sterile dosage forms in accordance with QTTP.
• Conduct experiments and analyze data to support product development by QbD concepts.
• Execution & monitoring of quantitative & qualitative pre-formulation studies of sterile dosage forms.
• Develop and optimize drug formulations using appropriate technology and scientific principles.

Qualifications

• M. Pharm graduate.
• 3 to 5 years experience developing and executing assigned projects of sterile formulations including simple & complex (injectables & ophthalmics).