(Senior) Director, Upstream Process Development

Job Summary：

The (Senior) Director of Upstream Process Development is responsible for leading the development and optimization of upstream processes, including cell line development and cell culture processes. This role is pivotal in ensuring the scalability, efficiency, and regulatory compliance of biologics production.

Responsibilities：

Cell Line Development

• Oversee the development of high-performing cell lines for the production of various biologics, including monoclonal antibodies, fusion proteins, and complex glycoproteins.
• Implement strategies for vector design, gene synthesis, host cell line selection, transfection, clonal selection, and characterization to ensure optimal expression and stability.
• Collaborate with cross-functional teams to ensure seamless integration of cell line development with downstream processes.

Upstream Process Development

• Lead the design, optimization, and scale-up of upstream processes, focusing on cell culture and fermentation.
• Develop and implement advanced bioreactor platforms, customized media formulations, and control strategies to maximize yields while maintaining product quality.
• Conduct process characterization and validation to ensure robustness and reproducibility.

Regulatory Compliance

• Ensure that all cell line and upstream process development activities comply with relevant regulatory guidelines and industry standards.
• Lead the preparation and review of regulatory submissions related to cell line and upstream process development.

Technology Transfer and Scale-Up

• Oversee the transfer of cell line and upstream processes from the lab to pilot and commercial scales.
• Work closely with manufacturing teams to ensure smooth implementation and troubleshooting of processes in production facilities.

Strategic Leadership

• Develop and implement the upstream process development strategy aligned with the company’s business objectives.
• Lead and mentor a team of scientists and engineers, fostering a culture of innovation and continuous improvement.

Qualifications：

Education

• Ph.D. in Bioengineering, Chemical Engineering, Molecular Biology, or a related field.

Experience

• At least 10-15 years of experience in cell line and upstream process development for large molecule biopharmaceuticals.
• Proven track record of leading and managing teams in a fast-paced environment.

Skills and Competencies

• Strong expertise in cell line development, cell culture, fermentation, and related technologies.
• In-depth knowledge of regulatory requirements for biopharmaceuticals.
• Excellent project management, leadership, and communication skills.

Personal Attributes

• Innovative and forward-thinking, with a passion for driving process improvements.
• Results-oriented with a strong focus on quality and efficiency