Assistant Manager – Microbiology & Bioassay

About the role

We are looking for a detail‑oriented Assistant Manager to lead microbiology and bioassay activities within our quality control and product development labs. The role supports regulatory compliance, method development and continuous improvement in a GMP environment.

Key responsibilities

• Perform microbiological, biochemical and cell‑based analyses on raw materials, in‑process and finished product samples.
• Execute assays such as microbial enumeration, sterility testing, endotoxin testing, ELISA, PCR and other bioassays.
• Maintain accurate laboratory documentation, logbooks and electronic data entry.
• Operate, calibrate and maintain instruments including microplate readers, isoelectric focusing systems, SDS‑PAGE setups and PCR platforms.
• Investigate out‑of‑specification, out‑of‑trend results and laboratory deviations.
• Ensure compliance with GMP, GLP, ALCOA+ data‑integrity principles and safety standards.
• Participate in method verification, transfer, validation and support audits, inspections and regulatory submissions.
• Contribute to SOP, protocol, report and training material preparation.

Required profile

• Bachelor’s or Master’s degree in Biology, Microbiology or Biotechnology.
• 4–6 years of experience in a pharmaceutical or biotechnology laboratory.
• Strong knowledge of microbiological and bioassay testing techniques.
• Hands‑on experience with laboratory instruments and computerized LIMS.
• Understanding of GMP, GLP and data‑integrity requirements.
• Experience handling OOS/OOT investigations.

Required skills

• Microplate reader operation
• Isoelectric focusing
• SDS‑PAGE
• ELISA
• PCR
• Microbial enumeration
• Sterility testing
• Endotoxin testing
• Cell‑based assay execution
• GMP/GLP compliance