Executive

Emcure Pharmaceuticals Limited; Pune District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Emcure Pharmaceuticals Limited in Pune is seeking a Sr. Research Fellow / Research Scientist (Executive/Asst.

Manager) with 3–6 years of industrial experience in protein characterization and analytical methods to join Biosimilar R&D (Analytical – Physicochemical parameters). You will lead hands-on work with HPLC, electrophoresis, spectroscopy and other bio-analytical assays, ensure GLP compliance, develop and validate methods, and prepare STPs, CMC and RCGM dossiers in line with ICH, WHO, FDA

Qualifications

• Hands-on experience with bio-analytical instruments and analytical methods.
• Strict GLP compliance in the bio-analytical lab is required.
• Prepare STPs, method development, qualification and validation reports.
• Handle CMC and RCGM dossier preparations.
• Strong knowledge of ICH, WHO, FDA, and EMA guidelines.
• Draft specifications for in-process, drug substance, and drug product with CoAs, calibration records, and logbooks.
• Added advantage: experience in structural studies and mass spectrometry analysis.

Responsibilities

• Hands‑on experience with bio‑analytical instruments (HPLC, gel‑electrophoresis, spectrophotometer, gel documentation, bio‑analytical assays).
• Ensure strict GLP compliance in the bio‑analytical lab.
• Prepare Standard Test Procedures (STP), method development, qualification, and validation reports.
• Handle CMC and RCGM dossier preparations.
• Strong knowledge of ICH, WHO, FDA, and EMA guidelines.
• Draft specifications for in‑process, drug substance, and drug product along with CoAs, calibration records, and logbooks.
• Added Advantage: Experience in structural studies and mass spectrometry analysis.

Skills

Protein characterization

Analytical method development

Education

M.Sc./M.Tech in Pharmaceutical Sciences, Biotechnology, or Biochemistry

Tools

HPLC

Gel electrophoresis

Spectrophotometer

Gel documentation

Bio-analytical assays

Job description

Position: Sr. Research Fellow / Research Scientist (Executive / Asst. Manager)

• Department: Biosimilar R&D (Analytical – Physicochemical parameters)


• Qualification: M.Sc. / M.Tech in Pharmaceutical Sciences, Biotechnology, or Biochemistry


• Experience: 3 – 6 years of industrial experience in protein characterization and analytical methods

Key Responsibilities:

• Hands‑on experience with bio‑analytical instruments (HPLC, gel‑electrophoresis, spectrophotometer, gel documentation, bio‑analytical assays).


• Ensure strict GLP compliance in the bio‑analytical lab.


• Prepare Standard Test Procedures (STP), method development, qualification, and validation reports.


• Handle CMC and RCGM dossier preparations.


• Strong knowledge of ICH, WHO, FDA, and EMA guidelines.


• Draft specifications for in‑process, drug substance, and drug product along with CoAs, calibration records, and logbooks.


• Added Advantage: Experience in structural studies and mass spectrometry analysis