Principal Scientist, Chemiluminescent Immunoassay

vor 2 Wochen


Munich, Deutschland Fapon Life Sciences GmbH Vollzeit

Company 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.

**Job Description**:
We are seeking a highly experienced and talented principal scientist for Chemiluminescent Immunoassay (CLIA) Reagent Optimization to support our German and Chinese development teams. As the principal scientist, you will be responsible for defining and optimizing our key development processes around CLIA reagent development. You will help our team in Germany and China to standardize and improve the key process steps and to solve difficult issues during the development of key reagents. This position will require tactical and operational leadership across multiple development centers and geographic locations worldwide.

**Key Responsibilities***
- Support 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 delivering 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.
- Participate in multifunctional project teams and collaborate across the organization to solve critical problems
- Ensure all FDA, ISO, and related regulatory requirements are consistently met.

**Qualifications**:
**Qualifications**:

- An advanced scientific degree in areas of life sciences, biochemistry, or other relevant areas
- 12+ years of experience in CLIA reagent development, ideally in high-performing enterprises
- Problem-solving capabilities paired with intercultural awareness and communication skills
- Experience working for leading CLIA companies and familiarity with the R&D system of leading CLIA companies
- Practical experience in effective development processes, system establishment, and familiarity with ISO13485
- Experience in 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 a good knowledge of surrounding areas including quality, regulatory and compliance, and manufacturing

**Personal Skills/Attributes**:

- Critical thinker able to address complex situations and issues. Personally accountable and takes ownership.
- Supports strategic plans, and executes on a tactical level.
- Express abstract and controversial ideas clearly and effectively: ensure communications, key decisions, and strategies are understood in all settings.
- Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals.

Additional Information
**About Fapon**

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.

An equal opportunity employer, Fapon welcomes and encourages diversity in our workforce.



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