Job Summary:
Our client currently recruiting for a Downstream Manufacturing Technology (MT) Scientist to support commercial drug substance manufacturing within a multi-product mammalian cell culture facility. This is a 12-month contract role offering the opportunity to work at commercial scale, providing technical support, process validation, and continuous process improvement. 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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