Manufacturing Specialist – Bioprocess Operations

About the role

The Manufacturing Specialist supports key manufacturing and quality systems with minimal supervision. You will apply scientific, operational and compliance expertise to ensure robust, compliant production of biopharmaceutical products.

Key responsibilities

• Initiate, revise and approve manufacturing procedures and act as document owner.
• Observe floor operations, review data and implement process improvement opportunities.
• Provide troubleshooting support and generate training materials for scientific and technical aspects.
• Support commercial campaigns with on‑floor troubleshooting and process monitoring.
• Collect and analyze monitoring data, assess deviations and contribute to quarterly reports.
• Manage non‑conformances, author investigation reports and drive CAPA closure within timelines.
• Assist in validation protocol development, execution and data interpretation.
• Participate in regulatory inspections, new product introductions and equipment modifications.
• Own change controls for manufacturing process changes and support Master Batch Record updates.
• Contribute to special projects, automation improvements and equipment assessments.

Required profile

• Strong knowledge of GMP production operations and regulatory requirements.
• Experience with bioprocessing unit operations such as cell culture and drug substance purification.
• Proven ability to assess documentation, training needs and equipment for new product introductions.
• Excellent analytical, troubleshooting and root‑cause investigation skills.

Required skills

• Bioprocessing unit operations (cell culture, drug substance purification)
• Good Manufacturing Practice (GMP) production
• Process validation and monitoring
• CAPA management and non‑conformance handling
• Root cause analysis and incident trend evaluation
• Master Batch Record creation and revision
• Bill of Materials (BOM) assessment
• Data analysis for process performance