Job purpose:
Fully responsible for the strategic planning and operational management of the cell line development, cell culture process development and/or downstream process development. Lead a technical team of approximately 150-200 personnel to deliver with high quality, effectively resolving complex issues and proactively providing crucial decision-making support for global projects. By defining technology roadmaps, driving the upgrading of upstream and downstream process development platforms and build new technical platforms to enhance our core competitiveness, thereby supporting the expansion of R&D business. Lead the blueprint planning and implementation of the digital and automation transformation.
Responsibilities:
1.Strategic Planning and Project Delivery:
- Fully responsible for the strategic planning and operational management of the cell line development, cell culture process development and/or downstream process development. Analyzing the internal and external environment such as market trends, competition and technology advancement, and make the operational plan with right resources to achieve the strategic objectives.
- Represent the company to resolve challenges in global projects, effectively identify and manage risks, track key project progress, and provide technical guidance to ensure smooth project execution and timely delivery.
2.Technical Platform Development and External Collaboration:
- Develop mid- long term technology strategies and roadmaps for cell line, cell culture and/or downstream development, defining core technology directions (e.g. cell line development, media optimization and cell culture processes, chromatography (affinity, ion exchange, hydrophobic), filtration/ultrafiltration, virus inactivation/removal etc.). Lead platform technology upgrades and capability expansions, promote cross-technology collaboration and innovation, and drive new technological breakthroughs and enhancing the core competitiveness and benefits of the business.
- Build internal and external technical collaboration networks; interface with leading academic institutions, industry partners, and regulatory bodies at home and abroad; participate in industry standard formulation to enhance the influence in global biopharmaceutical industry.
3.Business Development:
Participate in client meetings, assist the team in answering client questions, and propose effective solutions to client issues. Engage in business development activities, host visiting clients, promote the technology platform, and attract potential clients to sign agreements.
4.Organization and Talent:
- Recruit new employees for critical position, ensure department members receive appropriate training, and ensure team members comply with company and department policies, especially intellectual property protection policies.
- Responsible for organization structure design, training, talent development plans, performance management, promotions, and compensation etc. Systematically cultivate leadership at different levels, ensuring the talent pipeline for key positions to support the company’s growth.
5. Digitalization and Automation:
Lead or majorly participate in building the company’s digital and automated laboratory platforms, establishing information systems that highlight WuXi Biologics’ strengths. Provide critical data analysis and experiential support for company business development and operations. Lead the continuous iteration and upgrade of the lab to an intelligent automated lab based on algorithms and advanced intelligent control, innovating current work models, improving efficiency and setting industry technology digital trends.
6.Resource management and Cross-Department Collaboration:
- Manage department budgets and key resources (instrumentation, consumables, manpower); optimize resource allocation to improve operational efficiency.
- Act as a key interface in functional fields, collaborating deeply with Analytical, Quality, Clinical departments to solve cross-functional technical challenges and promote achievement of key project milestones.
Requirements:
Education
- PhD. in Molecular Biology, Cell Biology, Biochemistry or related fields.
Experience
- Over 15 years of research and development experience in the pharmaceutical industry;
- More than 15 years of professional experience in molecular biology, cell line construction, cell culture and downstream purification;
- Over 10 years of project management and team leadership experience.
Technical Skill
- Expert in one or two functional areas in Cell line, Cell Culture, Purification and proficient in process integration and management.
- Proficient in upstream technologies including cell line development (e.g., CHO, HEK293), media optimization, cell culture processes (feeding strategies, process control);
- Expert in downstream technologies such as chromatography (affinity, ion exchange, hydrophobic), filtration/ultrafiltration, virus inactivation/removal, and preliminary formulation screening, capable of resolving technical bottlenecks during process scale-up.
- Process development and optimization capabilities: Proficient in DOE (Design of Experiments), QbD (Quality by Design) concept; able to lead technical innovations (including PAT application, automation and digitalization) and enhance process stability and efficiency; able to lead process characterization and support process validation, ensuring process compliance with regulatory filing requirements, and responding to regulatory inspections.
- Successfully lead 2-3 technical platform development in 1-2 dedicated functional area and bring great impact to company strategy.
Soft Skill
- Problem Solving and Innovation: Able to solve highly complex problems through extensive analysis and modeling.
- Communication Skills and Influence: Represent the company or department in strategic negotiations and translate vision into strategic plans.
- Results Orientation: Strong sense of goals and a drive to achieve performance.
- Ownership: Proactive, innovative, and willing to take risks within controllable limits.
- Resilience and Adaptability: Maintain resilience and quickly adjust in the face of market fluctuations, internal and external organizational challenges, and complex problems; lead smooth transitions and transformations within the organization.
- Agile Learning: Continuously learn new technologies, regulations, and market dynamics.
- Big Picture Perspective: Able to think beyond daily operations and consider issues from the perspective of the entire industry and the whole organization.
- Excellent Leadership and Management: Build high-performance teams, make decisions effectively, and implement plan in complex and uncertain environments.
- Compliance Awareness: Place compliance and biosafety as the highest priorities.