Principal, Chemiluminescent Immunoassay - Munich, Deutschland - Fapon Life Sciences GmbH

Beschreibung

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 the latex synthesis and latex characterization group to support our German and Chinese reagent development teams.

As the expert in this domain, you will be responsible for synthesizing polymer microspheres for diagnostic purposes, including optimizing the synthesis process of functionalized polymer microspheres, quality control, and production scale-up.

In addition, the incumbent will develop and optimize the fundamental technology for the polymer microsphere platform, including material optimization, targeted modification, synthetic process, and characterization technology This position will require deep extensive problem-solving capabilities and solid communication skills across different teams.

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 synthesis and modification of microsphere within CLIA reagents development
• Establish and standardize labeling and coupling processes
• Provide technical guidance and training to both teams and participate in problemsolving processes.
• Participate in multifunctional project teams and collaborate across the organization at various levels, across functional groups and geographical locations
• Ensure all FDA, ISO, and related quality and regulatory requirements are consistently met.

Qualifications:


Minimum Qualifications:

• An advanced scientific degree in areas of life sciences, biochemistry, or other relevant areas
• 12+ years of experience in microsphere design and manufacturing, ideally in the CLIA reagent development industry
• Experience in setting up a system for particle modification, coupling, and manufacturing scaleup
• Innovative approach to new technologies and a track record in problemsolving critical issues during reagent development
• Global experience participating in crossfunctional teams

Preferred Qualifications:

• Practical experience in effective development processes, system establishment, and familiarity with ISO1348
• Experience in supporting and improving multiple CLIA reagents, ideally in the area of infectious diseases, myocardial diseases, tumors, hormones, and anemia.
• Critical knowledge in process optimization and KPI development for proper troubleshooting techniques
• Good communication and interaction skills ideally with different cultural background
• Possess a broad 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.
• Express abstract and controversial ideas clearly and effectively:
• Acts decisively, holds the position, and challenges others appropriately.
• Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals.

Additional Information

About Fapon

FAPON is committed to the research and development of in-vitro diagnostics (IVD), biotherapies and precision diagnostics, and the provision of related products and services.

Guided by "anticipation and readiness", one of its core values, FAPON focuses on three lines of business:
raw material solutions, the IVD ecosystem, and intelligent digital diagnosis & treatment.

Supported by its strong global R&D, manufacturing, sales, and service network, FAPON's products have established a presence in 68 countries and regions, serving more than 2,500 business partners.

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