Executive /Senior Executive - Analytical Development

Sun BioPharma, Inc.; Vadodara; On-site; INR 600,000 - 900,000; Full time

Job summary

Sun BioPharma, Inc. in Baroda invites applications for the role of Executive / Senior Executive – Analytical Development (Microbiology). The incumbent will support regulatory submissions for the India market and oversee hands-on microbiology testing with exposure to method development and validation.

Minimum 2 years of relevant experience, M.Sc. in Microbiology, and familiarity with CGMP/GLP and LIMS are desired. The position is on-site in Baroda, Gujarat.

Qualifications

• Exposure to Microbiology tests with hands-on experience.
• Experience in method development, validation, and routine analysis.
• Familiarity with non-oral and oral formulations.

Responsibilities

• Exposure to Microbiology tests with hands-on experience.
• Exposure to method development, method validation and routine analysis of non-oral and oral formulations.

Skills

Microbiology tests

Method development

Method validation

Routine analysis

CGMP compliance

GLP compliance

LIMS exposure

Documentation

Education

M.Sc. – Microbiology

Tools

LIMS

Job description

Executive / Senior Executive – Analytical Development (Microbiology)

Business Unit: R&D1 Regulatory Affairs

Job Grade: G12A / G11B

Location: Baroda

Job Summary

Regulatory submission of drug products for India market.

Job Description

• Exposure to Microbiology tests with hands‑on experience, 2–6 years.
• Preferably with exposure to Method development, Method validation and routine analysis of non‑oral formulations along with oral formulations.

Area of Experience

• Microbial Enumeration Test
• Test for specified micro‑organisms
• Bio‑burden Test
• Antimicrobial Effectiveness Test
• Sterility Test
• Bacterial Endotoxin Test
• Microbiological Assay
• Microbial culture propagation, maintenance and enumeration
• Growth Promotion Test
• Environment monitoring
• Preparation of documents as per CGMP
• Calibration of laboratory equipment/instruments
• Work as per cGMP/GLP compliance
• Exposure to LIMS

Job Requirements

Educational Qualification

Graduate: M.Sc. – Microbiology

Experience

Minimum 2 years of relevant experience

Disclaimer

The preceding job description has been designed to indicate the general nature and level of work performed by an employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).