SHDM IVD Sr. Biochemist
If you are ambitious and change makes you thrive, help transform Siemens Healthineers into a learning organization.
o This Sr. Biochemist position in the Technical Operations Department supports the manufacture of immunoassay products for Atellica and ADVIA Centaur systems diagnostic products in China Siemens Healthineers. This position will be based in Shanghai but will have frequent interactions with the Technical Operations group in Walpole, MA in the United States. Specifically, this position will support the transfer of immunoassay products from Walpole to the Shanghai facility, participating in equipment and instrument validation and product performance qualification, as well as preparing technical files required for regulatory submissions. Responsibilities also include Atellica and ADVIA Centaur Systems Immunoassay Products Manufacturing Support, maintaining necessary output to keep the China Immunoassay service position at an acceptable level. The position responsibilities will change and grow as the China Manufacturing project moves through different phases.
• AREAS OF RESPONSIBILTIES:
In addition to the specific responsibilities and duties listed above, the position also requires that the employee work within a team environment to:
o Assist management in developing, staffing, and training junior biochemists and technicians
o Lead or participate in technical studies including design or process changes as required during the technology transfer
o Collaborate with the Walpole team to transfer documents, test methods, and manufacturing processes
o Compile, review, and translate technical documents as needed
o Create and review protocols and reports for characterization, stability, verification and validation activities
o Provide technical support on locally sourcing raw materials used in the manufacturing process
o Investigate, troubleshoot, and resolve manufacturing issues
o Continuous improvement
This position may suit you best, if building learning organizations is your expertise and you have extensive experience with Top Management Learning and Leadership Development.
o MS or PhD in Biology, Chemistry, Biochemistry, Immunology, or Life Sciences
o 6 to 8 years job related experience.
• REQUIRED SKILLS:
o The candidate must have advanced knowledge of polyclonal and monoclonal antibodies and principles of immunodiagnostic technology, as well as working experience with immunoassays, such as automated immunoassay analyzers, ELISA, and chemiluminescent technology.
o Candidate must have demonstrated ability to interpret data and to troubleshoot and resolve technical issues.
o Candidate must also possess excellent written and communicational skills, a strong work ethic, and the ability to effectively prioritize and manage multiple assignments.
o Proficiency in Microsoft Office Applications and statistics software are also required.
• PREFERRED KNOWLEDGE/SKILLS, EDUCATION, AND EXPERIENCE:
o Advanced degree in Biology, Chemistry, Biochemistry, Immunology, or Life Science preferred.
o Previous assay development and/or technical troubleshooting experience in a GMP/GLP industry setting preferred.
o Good verbal and written skills with Mandarin and English languages.
Job ID: 71302
Organisation: Siemens Healthineers
Experience Level: Experienced Professional
Job Type: Full-time