Downstream Manufacturing Technology (MT) Scientist

A global biopharmaceutical manufacturing site is seeking to recruit a contract Downstream Manufacturing Technology (MT) Scientist. The Manufacturing Technology group is responsible for process validation and ongoing technical support for cell culture and primary recovery unit operations supporting the commercial manufacture of multiple mammalian cell processes in a multi-product facility.

The successful candidate will be a key contributor within a dynamic, highly technical, and global team, working closely with Manufacturing, Engineering, Quality Assurance, Quality Control, and Regulatory functions.

• Demonstrate strong understanding of the science behind drug substance manufacturing processes, with working knowledge of one or more of the following areas:
• Upstream (cell culture focus):
• Media preparation
• Large-scale cell culture drug substance manufacturing
• Vial thaw, scale-up activities, single-use systems
• Seed and production bioreactors
• Harvest, centrifugation, and clarification
• Downstream:
• Buffer preparation
• Purification and viral reduction steps
• Chromatography, ultrafiltration, viral reduction filtration, and viral inactivation technologies
• Drug substance formulation and bulk fill
• Author technical documentation including protocols, reports, and SOPs supporting manufacturing process validation
• Identify and implement process improvements (e.g., yield enhancement, cycle time reduction) using data analytics and process performance evaluation
• Generate protocols and lead execution of plant-supporting and technical studies at commercial scale
• Provide on-the-floor support for troubleshooting manufacturing issues and lead investigations into process deviations and resolution
• Act as a process subject matter expert during regulatory inspections and interactions with regulatory agencies
• Document and communicate work, outcomes, and learnings internally and externally (may include participation in scientific meetings)
• Support continuous improvement initiatives through change control, CAPA, and Lean methodologies

• Minimum BSc (or equivalent) with at least 2 years' experience in drug substance manufacturing technical support within the biopharmaceutical industry
• Demonstrated knowledge of cGMP compliance and regulatory requirements
• Strong oral communication and technical writing skills
• Proven ability to work effectively in cross-functional, matrix, and global team environments
• Ability to develop, present, and defend technical and scientific approaches both verbally and in writing
• Capable of influencing stakeholders and driving technical decisions without direct line authority, while balancing product quality and operational needs

• This role may occasionally require extended hours, modified work schedules, or on-call availability
• On-site presence is a required component of this role to support collaboration, productivity, and operational effectiveness