Head of Upstream Process Development (Mammalian Bioprocess)

Job Description: Head of Upstream Process Development (Mammalian Bioprocess)
Position Overview: We are seeking an experienced and dynamic Head of Upstream Process Development (Mammalian Bioprocess) to lead the development, optimization, and scale-up of mammalian cell culture processes for recombinant therapeutic proteins. The role involves managing a team, overseeing process development, ensuring regulatory compliance, and facilitating technology transfer to manufacturing.

Key Responsibilities:
Team Leadership & Management

1. Supervise, train, and manage the Upstream Process (USP) team focused on mammalian cell culture.
2. Plan and delegate daily activities, ensuring efficient workflow execution.
3. Develop strategies for the USP group and monitor goal achievement.

• Lab Setup & Design

1. Design and establish the Mammalian Upstream Process Development Laboratory.
2. Ensure proper selection, installation, and qualification of bioreactors and associated equipment.
3. Optimize lab workflows to enhance efficiency and meet process development needs.

• Upstream Process Development

1. Lead upstream process development for recombinant therapeutic proteins using mammalian cell lines.
2. Define and implement upstream strategies to improve process performance, productivity, and scalability.

• Media & Feed Optimization

1. Optimize chemically defined media and feed formulations to enhance yield and process consistency.
2. Conduct gap-filling studies to refine and improve existing processes.

• Scale-Up & Tech Transfer

1. Oversee scale-up activities from small-scale development to pilot-scale and GMP manufacturing.
2. Coordinate with manufacturing teams to ensure smooth technology transfer and troubleshooting.

• CDMO & Business Support

1. Participate in CDMO activities, including RFQ reviews, gap analysis, and cost estimation.
2. Provide technical expertise for business and project development discussions.

• Quality by Design (QbD) & DOE Implementation

1. Implement QbD approaches for mammalian process optimization.
2. Execute DOE using statistical tools for process development and optimization.

• Documentation & Compliance

1. Review logbooks, lab notebooks (LNBs), protocols, reports, and project-related documents.
2. Ensure compliance with regulatory requirements and support submission documentation.
3. Address regulatory queries and assist in IND/BLA submissions.

• Preclinical Data & Regulatory Support

1. Generate preclinical data required for regulatory submissions.
2. Assist in regulatory documentation and compliance activities.

• Resource & Team Development

1. Develop and update employee training programs to ensure team competency.
2. Efficiently allocate lab resources to meet project requirements.

• Problem Solving & Innovation

1. Take ownership of cell culture process development, troubleshooting, and continuous improvement.
2. Identify technical challenges and develop innovative solutions.

• Cross-Functional Coordination

1. Collaborate with Downstream Processing, Analytical R&D, Regulatory Affairs, and Quality Assurance teams.
2. Ensure seamless interdepartmental communication for successful project execution.