Team Member - Mfg. USP, CDMO Biologics

Scientist – Upstream Process Manufacturing (USP) | CDMO Biologics

Location: Hyderabad

Qualification: 5-8 years of industry experience

Role Overview

We are looking for a team member with strong experience in upstream manufacturing operations to support biologics development and manufacturing programs. The individual will be responsible for executing and supporting cell culture and fermentation activities, documentation, process monitoring, troubleshooting, compliance, and cross-functional coordination in a GMP environment.

Key Responsibilities

• Execute and support upstream manufacturing operations, including mammalian cell culture and bioreactor processes.
• Prepare, review, and maintain manufacturing documents, SOPs, batch records, protocols, and reports.
• Support commissioning, qualification, validation, and technology transfer activities.
• Monitor process performance and assist in troubleshooting manufacturing issues to ensure uninterrupted operations.
• Ensure all manufacturing activities are performed in compliance with approved procedures, GMP requirements, and safety guidelines.
• Coordinate with downstream, QA, QC, engineering, warehouse, and other cross-functional teams for smooth execution of manufacturing activities.
• Participate in deviation investigations, CAPA implementation, change controls, and risk assessment activities.
• Support equipment qualification, calibration, maintenance, and routine operational readiness activities.
• Maintain accurate documentation and timely reporting of manufacturing activities.
• Contribute to process improvements, operational excellence initiatives, and continuous improvement projects.
• Track and support achievement of manufacturing KPIs and production targets.
• Ensure adherence to environmental health and safety requirements and maintain a clean manufacturing environment.

Required Skills

• Hands-on experience in mammalian cell culture and upstream bioprocess operations.
• Good understanding of bioreactors, media preparation, seed train operations, and process monitoring.
• Knowledge of GMP documentation practices and quality systems.
• Experience in troubleshooting upstream manufacturing processes.
• Strong documentation, communication, and team collaboration skills.

Preferred Skills

• Experience in monoclonal antibody (mAb) manufacturing.
• Exposure to commissioning, qualification, and validation activities.
• Knowledge of technology transfer and process characterization activities.
• Experience with single-use bioreactor systems and large-scale manufacturing operations.

Key Competencies

• Good analytical and problem-solving skills
• Strong execution and documentation skills
• Teamwork and cross-functional collaboration
• Attention to detail and compliance mindset
• Ability to manage priorities and work in a fast-paced manufacturing environment