Senior Research Associate

Aveva Drug Delivery Systems; Hyderabad; On-site; INR 47,619,000 - 76,190,000; Full time

Job summary

Aveva Drug Delivery Systems in Hyderabad, India, seeks a M. Pharm in Pharmaceutics with 4–6 years of formulation development experience for oral solid and oral liquid dosage forms.

Experience in DR/ER pellets and platform tech such as Hot Melt Extrusion, extrusion and spheronization is essential. Responsibilities include preparing tech transfer documents (MFR, BOM, stability, photostability, thermal cycle, reconstitution studies), reviewing reports and executing TT activities, aiding regulatory

Qualifications

• M. Pharma in Pharmaceutics with 4 to 6 years of experience in formulation development of oral solid and oral liquid dosage forms
• Experience in DR and ER Pellets formulations and platform technologies such as Hot Melt Extrusion (HME), Extrusion and Spheronization and other solid dispersion is must.

Responsibilities

• Tech transfer documents: MFR, BOM, Stability protocol and report, Photostability protocol and report, Thermal cycle study protocol and report, In use study protocol and report, Reconstitution study protocol and report, Specifications
• Review of reports. Execution of TT activity
• Regulatory filing document like 3.2.p.1, PDR (3.2.p.2) and other
• Stability Data Interpretation.
• Technology transfer to CMO site and support for SU and EB execution
• Address to regulatory queries

Skills

Formulation development

Solid dispersions

HME (Hot Melt Extrusion)

Extrusion

Spheronization

Tech transfer activities

Stability data interpretation

Regulatory support

Education

M. Pharma in Pharmaceutics

Job description

Job Details

• Job Location: Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072
• Salary Range: $500,000.00 - $800,000.00 Salary/year
• Job Shift: Day1.

Formulation Development experience with specific dosage forms (e.g., Oral solid, Oral liquid etc.)

1. Expertise in development of formulations with solid dispersions, wurster techniques and handling of low dose and potent molecules
2. Tech transfer documents: MFR, BOM, Stability protocol and report, Photostability protocol and report, Thermal cycle study protocol and report, In use study protocol and report, Reconstitution study protocol and report, Specifications
3. Review of reports. Execution of TT activity
4. Regulatory filing document like 3.2.p.1, PDR (3.2.p.2) and other
5. Stability Data Interpretation.
6. Technology transfer to CMO site and support for SU and EB execution
7. Address to regulatory queries

Qualifications

• M. Pharma in Pharmaceutics with 4 to 6 years of experience in formulation development of oral solid and oral liquid dosage forms
• Experience in DR and ER Pellets formulations and platform technologies such as Hot Melt Extrusion (HME), Extrusion and Spheronization and other solid dispersion is must.