Senior Biochemist for Technical Operations at Siemens Healthcare Diagnostics Inc. in Mishawaka, Indiana

Job Description:

Who we are:



We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.


Our culture : We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what's possible, to improve people's lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers .


The successful candidate will participate in a wide variety of semi-complex technical assignments to support the manufacture of immunochemistry diagnostic tests for the cardiac market . The position involves systematic troubleshooting of complex reagent manufacturing formulations and processes both in individual and team-based projects. The incumbent will be responsible to help write and execute validation plans, lead root-cause analysis efforts, and identify/implement process/equipment improvements. This person must be highly competent at planning/executing complex lab studies and utilizing specialized testing techniques. Must also be able to analyze, interpret, and present complex data for review and summarize results in a technical report. The candidate must be capable to function as a project manager for our cardiac product line as needed, leading multiple cross-functional team workstreams with regular supply chain management updates. The medical device industry is highly regulated, and the candidate must be able to support compliance with ISO and FDA requirements.


Major tasks and responsibilities:


• Conduct validation and verification activities to ensure project completion within expected parameters and time frame.


• Design and conduct experiments to identify process issues related to undesirable reagent or manufacturing performance, and identify resolutions for those issues.


• Plan, conduct, analyze, and document experiments necessary to improve manufacturing process capability and reduce costs associated with paper-based reagent production.


• Lead cross-functional manufacturing support team and mentor junior biochemists.


• Function as project manager for cardiac marker product line initiatives as needed.


• Collaborate with R&D personnel on product design changes and become a subject matter expert with respect to cardiac product reagent chemistry.


• Lead root-cause investigations and drive implementation of those solutions to improve reagent performance and manufacturability.


• Able to design complex experiments, execute test protocols, and analyze/interpret their results.


• Apply principals of lean manufacturing and support continuous improvement activities to meet quality, cost and supply requirements.


• Effectively communicate (oral and written) work progress in both intra- and inter-departmental team forums.


• Provide well-written, coherent progress updates, validation documents, study protocols, and technical reports.


• Participate in supplier and internal audits; able to interact effectively with key suppliers.


Qualifications:



• Preferred Bachelors or Masters in Biochemistry or Chemistry.

• Min 5 years' experience, preferably in a medical device or related industry


• Expertise and deep knowledge in protein chemistry


• Strength in one or more of the following areas: Clinical Chemistry, Immunoassays, Biostatistics, Manufacturing Process Capability, and Computer Science.


• Proven experience in successful root cause analysis and resolution of manufacturing or design issues.


• Demonstrated competence in experimental design and data interpretation.


• Working knowledge of basic statistics necessary to develop sampling plans and analyze data.


• Able to prepare technical reports and testing protocols per approved department and site procedures.


• Must be well versed in Office Applications, particularly Excel and Access; experience in SAP or Minitab desired.


• Some travel (< 10%) may be required.


Other characteristics of the successful candidate:



• Very organized, detail-oriented


• Highly self-motivated


• Able to work independently


• Excellent analytical, communication, writing, and problem-solving skills


• Effective and influential in his/her interactions in team-based assignments


• Able to work well with personnel from different departments, and experience levels


• Lean Manufacturing and CAPA Investigator experience


• Demonstrates good laboratory and manufacturing practices


• Working knowledge of manufacturing process performance trending


• Expertise and deep knowledge in protein chemistry


At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.



If you want to join us in transforming the way healthcare is delivered, visit our career site at https://jobs.siemens-healthineers.com/careers


If you wish to find out more about the specific division before applying, please visit: https://usa.healthcare.siemens.com/about .



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