Upstream Production (Mammalian & MABs)

Role & responsibilities

• Lead the upstream process group to design and develop cell culture processes for monoclonal antibody and fusion protein production.
• Provide expert leadership overseeing both strategic and day-to-day activities in upstream process development of complex novel biologics.
• Oversee technology transfer to support scale-up and GMP manufacturing. Build strong relationships with CMOs, to optimize efficiency, productivity, quality and supply assurance.
• Design and execute risk-based process characterization studies to define critical process parameters (CPPs) and critical quality attributes (CQAs).
• Employ DOE and QbD principles for process optimization and robustness assessment.
• Scale-up process from laboratory-scale bioreactors to pilot and commercial-scale, ensuring process robustness and consistency in compliance with regulatory requirement.
• Prepare technology transfer protocols/descriptions and execute transfer to clinical and commercial manufacturing sites.
• Collaborate with downstream processing, analytical development, and quality assurance teams to ensure seamless integration of upstream processes.
• Liaise with regulatory affairs to ensure compliance with industry standards and guidelines.
• Analyze experimental data to draw meaningful conclusions and make data-driven decisions.
• Prepare and present technical reports, project updates, and scientific findings to senior management and stakeholders.
• Ensure that all upstream processes are compliant with cGMP, ICH, FDA, EMEA regulatory requirements.
• Prepare and review process descriptions and CMC sections of regulatory documents to support regulatory submissions as required for IND and BLA.
• Develop and implement strategic plans to achieve project milestones and goals.
• Mentor and develop team members to foster a high-performance culture.