Senior/director, Chemiluminescent Immunoassay

Company Description Founded in 2001 and headquartered in Guangdong, China, Fapon Group is mainly engaged in product R&D and services of in vitro diagnostic (IVD), biological therapy, and precise diagnosis and treatment. With our core value of "foresee and prepare for what future demands", Fapon focuses on three major businesses: raw material solutions, IVD ecosystem platform service, and intelligent digital diagnosis and treatment. Based on the global industrial ecology, Fapon has established major production and sales (R&D) bases in Beijing, Shenzhen, Shanghai, the United States, Germany, India, and other locations throughout the world, forming a global R&D, production, marketing, and service network, with products being widely sold to 61 countries and regions. **Job Description**: Fapon is an industry-leading IVD platform organization that offers an unmatched product and service combination of innovative biomarkers and bioactive raw materials, and one-stop solutions of Open Instrument Systems and Reagents, with our mission to enable earlier disease identification and more timely, accurate, and affordable diagnosis. Nowadays, we have well-developed open platforms of the chemiluminescent analyzer, PCR system, SBS-based gene sequencer, etc. To complement the chemiluminescent systems solution Fapon established a CLIA reagent team in China to deliver highly competitive immunoassay solutions. In order to further improve the quality and performance of reagent development capabilities we plan to build a second reagent development in Munich, Germany with a leader based in Germany overseeing the management of both organizations. Therefore, we invite you to consider this unique opportunity to co-incubate and bring further technological breakthroughs with us. We are seeking a highly experienced and talented Leader for Chemiluminescent Immunoassay (CLIA) Reagent Development to lead our German and Chinese development teams. As the leader of this domain, you will be responsible for successfully developing and improving CLIA reagents while building and developing a high-performing reagent development team in Munich, Germany. This position will require strategic and operational leadership across multiple development centers and geographic locations worldwide. **Key Responsibilities*** - Plan, direct, and manage the German and Chinese reagent development teams to ensure the timely completion of products at projected costs within specified performance parameters. - Develop and improve CLIA reagents' performance by researching and improving fundamental technologies - Establish and standardize reagent development processes, including setting up a CLIA technology platform for the German development team. - Provide technical guidance and training to both teams and participate in strategic and tactical planning processes. - Develop resourcing strategies, and allocate budgets, staff, tools, and specialized support necessary for efficient operations. - Participate in multifunctional project teams and collaborate across the organization at all levels, across functional groups and geographical locations, including executive management, to manage matrices effectively. - Develop and maintain strong collaborative development partnerships with other companies, academic institutions, and opinion leaders. - Ensure all FDA, ISO, and related regulatory requirements are consistently met. **Qualifications**: **Minimum Qualifications**: - An advanced scientific degree in areas of life sciences, chemistry, or other relevant areas - 15+ years of experience in regulated reagent development, ideally in the diagnostic industry - 10+ years of supervisory and management experience - Experience working for leading CLIA companies and familiarity with the R&D system of leading CLIA companies - Global experience leading and/or participating in cross-functional teams **Preferred Qualifications**: - Practical experience in effective development processes, system establishment, and familiarity with ISO13485 - Experience developing and sustaining multiple CLIA products, ideally in the area of infectious diseases, myocardial diseases, tumors, hormones, and anemia - Critical knowledge of instrument-reagent integration including proper troubleshooting techniques - A demonstrated ability to lead in technologies for CLIA development (reagent reaction, anti-interference, and formula development) with products having high market penetration - Possess the skills, experience, and know-how to bring together the development functions at multiple locations to create an organization that supports the business worldwide - Demonstrates deep knowledge of reagent development, characterizing key performance indicators for reagent functionality, and key raw material characterization. Also has excellent knowledge of reagent transfer into operation - Possess a broad knowledge of surrounding areas including quality, regulatory and compliance, and manufacturing **Persona