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Head of Overseas Site Engineering
Job in
Durham, Durham County, North Carolina, 27703, USA
Listed on 2026-08-03
Listing for:
Innovent Biologics
Full Time
position Listed on 2026-08-03
Job specializations:
-
Business
Regulatory Compliance Specialist
Job Description & How to Apply Below
As the company's internationalization strategy advances in depth and global strategic partnerships with MNC pharmaceutical companies materialize, Innovent Biologics needs to establish its own antibody and ADC manufacturing capacity in the United States to support the global supply chain layout and overseas commercialization needs. This role will be responsible for the full lifecycle management of the US manufacturing site- from site selection, leasing, and facility setup to subsequent operations team building and operations management- and is a key role in the execution of the company's globalization strategy.
Core Responsibilities:I. Site Selection and Business Negotiation (Pre-Construction Phase)
- Identify ready-built facilities/plants meeting antibody and ADC manufacturing requirements in target US regions (prioritizing North Carolina, Maryland, Texas, and the Bay Area, California), and conduct comprehensive technical assessments and commercial due diligence;
- Lead business negotiations with property owners, local governments, and economic development agencies, including lease terms, tax incentives, and policy support;
- Oversee and coordinate local approval processes including design, environmental impact assessment, and construction permitting to ensure compliant project progression;
- Establish long-term collaborative relationships with relevant US government agencies, industry associations, and key industry stakeholders.
- Transition to Site Head upon completion of facility construction, with full responsibility for the day-to-day operations management of the US manufacturing site;
- Oversee all functional areas including manufacturing, quality, engineering, and supply chain, ensuring site operations comply with FDA cGMP and the company's global quality standards;
- Drive production ramp-up and continuous optimization to ensure timely supply for overseas clinical and commercial-stage demands.
- Responsible for building the core team at the US site, including key positions in manufacturing, quality, engineering, and supply chain;
- Establish an organizational management system that aligns with both local US culture and Innovent's corporate culture;
- Oversee the overseas supply chain layout to ensure efficient coordination between US manufacturing capacity and the global supply chain system.
1. Geographic and Living Background
- Long-term work and living experience in the US, familiar with the local business environment and culture; eligible to work legally in the United States.
- Deep experience in the biopharmaceutical industry, familiar with the design, operations, and compliance requirements of antibody manufacturing facilities;
- Experience with ADC (Antibody-Drug Conjugate) manufacturing facilities is preferred;
- Familiar with US operational standards and regulatory requirements for biopharmaceutical cGMP manufacturing facilities.
- Familiar with US local laws and regulations, particularly environmental and safety regulations related to biopharmaceutical manufacturing facilities;
- Extensive network of contacts in the US industrial sector, especially in the biopharmaceutical manufacturing facility space;
- Strong business negotiation skills and cross-cultural communication abilities;
- Ability to independently lead site selection, assessment, and execution of large-scale projects.
- Bachelor's degree or above, majoring in Bioengineering, Pharmaceutical Engineering, Chemical Engineering, or related fields is preferred;
- Fluent in both Chinese and English, with business-level English communication skills for the workplace.
- Experience in successfully leading biopharmaceutical manufacturing facility site selection and lease/purchase projects in the US;
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