Head of Upstream Process (USP) Development

Reports to: Director of Biotechnology

Job description:

• Stay abreast of technical advancements in the USP area of microbial cell line development and fermentation process development.
• Apply technical knowledge and expertise in cell line development (cloning, cell banking, and testing, clone selection, cell line stability testing, etc), upstream process development (fermenters design, media, and feed optimization, etc), and technology transfer to the pilot group and to different CMOs.
• Support transfer, development, and scale-up of microbial fermentation process technology from research into process development and scale-up to enable production.
• Collaborate with internal and external partners in downstream process development, analytical development, and pilot groups to advance CMC biologics programs.
• Deliver technical support to ensure successful small and pilot production, and to develop and implement process improvements as programs advance.
• Lead and support early-stage upstream process development activities.
• Analyze, interpret, present, and document the technical information such as cloning, sequence, and development data, in support of regulation objectives.
• Work with international contract development manufacturing organizations (CDMOs) to help define project scope, review proposals, and oversee technical work, including reports’ review and approval.
• Contribute to process regulatory strategies and submissions, and quality documentation.
• Work to establish, maintain, and lead internal upstream process development.
• Contribute to the preparation of grant applications and reports as well as workplans, KPIs, and reports to the management.

Requirements:

• PhD in biology, biochemistry, biochemical engineering, or related field.
• A minimum of five years’ experience in relevant process development for protein production.
• Experience with clone selection, fermentation process optimization in various formats, and process scale-up.
• Demonstrated capability to work independently on complex technical problems, effectively in cross-functional teams, and with external CDMOs and partners.
• Experience in planning, generating, analyzing, and linking experimental capabilities and results to critical USP objectives.

Knowledge/Skills:

• Expertise in upstream process development
• Broad and deep knowledge of CMC biologics upstream processes.
• Working knowledge of proteins’ microbial cell line development workflows.
• Ability to apply technical knowledge to development and manufacturing for biologics across the product life cycle.
• Ability to collaborate with and lead effectively cross-functionally and in a team setting, both internally and with external CDMOs and partners.
• Ability to multi-task in a fast-paced dynamic environment while delivering high-quality work.
• Set goals with an understanding of priority and impact on the program, department, and organization.
• Creative thinker and complex problem solver.
• Must have outstanding interpersonal relations and team working capabilities.