Officer/Sr.Officer - MicrobiologyAmbernath

Officer / Sr. Officer – Microbiology

Department

Microbiology – Quality Control

Designation

Officer / Sr. Officer

Reporting To

Section Head – Microbiology QC

Location

Ambernath / Navi Mumbai, Maharashtra, India

Educational Qualification

M.Sc. / B.Sc. in Microbiology, Biotechnology, or related Life Science discipline

Experience

3–6 years of relevant experience in pharmaceutical, peptide, API, or biotechnology industry

About Us

PolyPeptide Group is a specialized Contract Development & Manufacturing Organization (CDMO) focused on peptide- and oligonucleotide-based active pharmaceutical ingredients (APIs). With a strong global presence across Europe, the U.S., and India, PolyPeptide supports pharmaceutical and biotechnology companies from pre-clinical development to commercial manufacturing while contributing to therapies that improve millions of lives worldwide.

Purpose of the Role

To perform microbiological testing, environmental monitoring, and quality control activities for peptide manufacturing operations while ensuring compliance with GMP, GLP, and global regulatory requirements. The role supports microbiological compliance, contamination control, laboratory operations, investigations, and audit readiness.

Key Responsibilities

• Perform microbiological analysis of:

  • Raw materials

  • In-process samples

  • Finished peptide products

  • Stability samples

• Conduct IPQC microbiological testing during manufacturing activities.

• Perform Environmental Monitoring (EM) activities for cleanroom areas including:

  • Air monitoring

  • Surface monitoring

  • Personnel monitoring

  • Water system monitoring and analysis

• Perform microbiological testing including:

  • Microbial Limit Test (MLT)

  • Bacterial Endotoxin Test (BET)

  • Sterility testing as per pharmacopoeial requirements

• Prepare culture media and microbial cultures and conduct Growth Promotion Testing (GPT).

• Handle culture maintenance, media preparation, and microbiological laboratory activities.

• Investigate Out of Specification (OOS), deviations, contamination events, and atypical results.

• Participate in root cause analysis and implementation of corrective and preventive actions (CAPA).

• Maintain proper documentation, logbooks, worksheets, and test records in compliance with GMP/GLP and data integrity requirements.

• Ensure calibration, qualification, and maintenance of microbiology laboratory instruments and equipment.

• Participate in method validation, method verification, and microbiological method transfer activities.

• Prepare and review protocols, reports, SOPs, specifications, and related GMP documents.

• Perform risk assessment activities to identify, evaluate, and mitigate quality and compliance risks.

• Support internal audits, customer audits, and regulatory inspections while ensuring audit readiness.

• Coordinate with QA, Production, Engineering, and other cross-functional teams for issue resolution and compliance management.

• Follow laboratory safety practices and maintain housekeeping standards in the microbiology laboratory.

Required Skills & Competencies

• Strong knowledge of microbiological techniques including:

  • Sterility Testing

  • Microbial Limit Testing (MLT)

  • Bacterial Endotoxin Testing (BET)

  • Environmental Monitoring (EM)

• Good understanding of:

  • GMP

  • GLP

  • Data Integrity practices

  • ICH guidelines

• Hands-on experience in aseptic techniques and cleanroom monitoring.

• Strong documentation and technical writing skills related to SOPs, protocols, reports, and laboratory records.

• Experience in protocol preparation, execution, and report compilation.

• Ability to handle deviations, OOS investigations, CAPA, and risk assessment activities.

• Good analytical, troubleshooting, and problem-solving skills.

• Strong attention to detail and compliance-oriented mindset.

• Effective communication and teamwork abilities.

• Basic computer proficiency and knowledge of laboratory documentation systems.

Preferred Attributes

• Experience in peptide manufacturing or sterile pharmaceutical environment preferred.

• Exposure to regulatory audits such as USFDA, MHRA, EU GMP, or WHO audits will be an added advantage.

• Knowledge of laboratory systems such as LIMS or electronic documentation systems preferred.

• Self-motivated and capable of working in a fast-paced GMP environment.

Why Join Us at PolyPeptide Group

At PolyPeptide Group, you will be part of a globally recognized organization specializing in peptide therapeutics, one of the fastest-growing areas in the pharmaceutical industry. You will gain exposure to advanced manufacturing technologies, international quality standards, and collaborative global projects while contributing to products that improve patient lives worldwide._)

Locations

Ambernath

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