Senior Research Associate

Paycom - ATS; Telangana; On-site; INR 48,216,000 - 77,146,000; Full time

Job summary

Paycom - ATS in Hyderabad, India, seeks a Formulation Development professional with 4–6 years of experience in oral solid and oral liquid dosage forms.

Role involves DR/ER pellets, solid dispersions, tech transfer to CMO, and regulatory filings (3.2.p.1, 3.2.p.2). Expertise in HME and stability studies is required.

Qualifications

• Formulation development experience for oral solid and oral liquid dosage forms.
• Experience with DR and ER pellets and platform technologies such as HME, extrusion and spheronization.
• Knowledge of regulatory filing documents and stability protocols.

Responsibilities

• Prepare tech transfer documents and support TT activity.
• Review and address regulatory queries and stability data interpretation.
• Coordinate technology transfer to CMOs and support SU/EB execution.

Skills

Formulation development

Pellet technologies

Hot Melt Extrusion (HME)

Regulatory filing knowledge

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: Day
• Formulation Development experience with specific dosage forms (e.g., Oral solid, Oral liquid etc.)
• Expertise in development of formulations with solid dispersions, wurster techniques and handling of low dose and potent molecules
• 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

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.