Head of Upstream Process Development & Clone Development

Job Description: Head of Upstream Process Development & Clone Development (Microbial Bioprocess)
Position Overview: We are seeking an experienced and dynamic Head of Upstream Process Development (Microbial Bioprocess) to lead the development, optimization, and scale-up of microbial fermentation processes for recombinant proteins, enzymes, and biologics. This role requires expertise in microbial fermentation, process intensification, regulatory compliance, and technology transfer to manufacturing.
Key Responsibilities:

Team Leadership & Management

• Supervise, train, and manage the Upstream Process (USP) team focused on microbial fermentation.
• Plan and delegate daily activities, ensuring efficient workflow execution.
• Develop strategies for the USP group and monitor goal achievement.

Lab Setup & Design

• Design and establish the Microbial Upstream Process Development Laboratory.
• Ensure proper selection, installation, and qualification of bioreactors and microbial fermentation equipment.
• Optimize lab workflows to enhance efficiency and meet process development needs.

Clone Development & Strain Engineering

• Lead microbial strain selection and genetic optimization for recombinant protein expression.
• Develop high-yielding microbial clones for improved productivity and process robustness.
• Collaborate with molecular biology teams for plasmid design, vector construction, and host cell engineering.

Upstream Process Development

• Lead upstream process development for recombinant therapeutic proteins, enzymes, and biologics using microbial hosts (e.g., E. coli, Pichia pastoris, Bacillus spp.).
• Define and implement upstream strategies to improve cell growth, productivity, and process scalability.

Media & Feed Optimization

• Optimize media formulations and feeding strategies for high-density fermentation.
• Conduct gap-filling studies to refine and improve existing fermentation processes.

Scale-Up & Tech Transfer

• Oversee scale-up activities from shake flasks to pilot-scale and GMP fermentation.
• Coordinate with manufacturing teams for seamless technology transfer and troubleshooting.

CDMO & Business Support

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

Quality by Design (QbD) & DOE Implementation

• Implement QbD approaches for microbial fermentation optimization.
• Execute DOE using statistical tools for process development and optimization.

Documentation & Compliance

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

Preclinical Data & Regulatory Support

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

Resource & Team Development

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

Problem Solving & Innovation

• Take ownership of microbial fermentation process development, troubleshooting, and continuous improvement.
• Identify technical challenges and develop innovative solutions.

Cross-Functional Coordination

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