Manufacturing Technology Scientist New

Job Summary:

The successful candidate will be a key contributor within a global Manufacturing Technology team, supporting both upstream and downstream operations while acting as a technical subject matter expert on the manufacturing floor.

Responsibilities:

• Provide technical support to commercial drug substance manufacturing processes, with strong scientific understanding of mammalian cell culture operations.
• Support upstream and/or downstream processes including:
• Cell culture operations, media preparation, scale-up, single-use systems, bioreactors, harvest and clarification.
• Downstream processing including buffer preparation, chromatography, viral inactivation and filtration, ultrafiltration, formulation, and bulk fill.
• Author and review technical documentation including protocols, reports, and SOPs to support process validation and lifecycle management.
• Lead and execute plant-based technical studies and supporting studies at commercial scale.
• Provide on-the-floor support for troubleshooting manufacturing issues and lead or support deviation investigations.
• Identify and implement process improvements related to yield, robustness, and cycle time using data-driven approaches.
• Act as process SME during regulatory inspections and interactions.
• Support change control, CAPA, and Lean/continuous improvement initiatives.
• Communicate technical learnings effectively across internal stakeholders and external forums where required

Requirements:

• BSc degree (or equivalent) in a scientific or engineering discipline.
• Minimum 2 years’ experience providing technical support within drug substance manufacturing in the biopharmaceutical industry.
• Strong knowledge of cGMP requirements and regulatory expectations.
• Proven experience authoring technical and GMP documentation.
• Strong communication skills with the ability to influence and collaborate across cross-functional and global teams.
• Ability to present and defend technical approaches clearly in both written and verbal formats.
• Comfortable working on-site in a fast-paced commercial manufacturing environment.
• Flexibility to support occasional extended hours or on-call activities if required.

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