A global leading biopharmaceutical manufacturing facility is seeking a contract Downstream Manufacturing Technology (MT) Scientist to provide process validation and technical support for the commercial production of mammalian cell processes. This role is a key contributor to a highly technical global team, collaborating closely with Manufacturing, Engineering, Quality Assurance, Quality Control, and Global Regulatory Sciences.

Key Responsibilities:

• Act as a subject matter expert in Downstream Processing (DSP), including:
  • Buffer preparation, purification, and viral reduction steps.
  • Chromatography, ultrafiltration, viral reduction filtration, viral inactivation, DS formulation, and bulk fill.
• Author technical documents, including validation protocols, reports, and SOPs.
• Identify and implement process improvements to enhance yield and reduce cycle time using data analytics tools.
• Lead and execute technical studies and plant support studies at commercial scale.
• Provide on-the-floor troubleshooting support for process deviations and lead investigations.
• Support regulatory inspections and act as an SME for interactions with regulatory agencies.
• Document and communicate learnings across internal and external forums, including potential participation in scientific meetings.
• Drive process improvements through change control, CAPA, and Lean initiatives.

Qualifications & Experience:

• BSc or higher in a scientific discipline with at least 2 years of experience in biopharmaceutical drug substance manufacturing technical support.
• Strong understanding of cGMP compliance and regulatory requirements.
• Excellent technical writing and oral communication skills.
• Ability to work in a global matrix environment and effectively collaborate across teams.
• Strong problem-solving skills with the ability to balance product quality and operational requirements.

Additional Information:

• The role may occasionally require extended hours, modified work schedules, or on-call availability.
• This is an on-site position that requires physical presence to support collaboration, innovation, and productivity.

What’s on Offer?

• Competitive contract opportunity with exposure to cutting-edge biopharmaceutical manufacturing.
• Work within a highly technical and collaborative global environment.
• Opportunity to develop and drive process improvements in a commercial-scale facility.

If you’re interested in this opportunity, apply today to discuss how this role could be the next step in your career!