Senior Biochemist For Technical Operations

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. Thesuccessful candidate will participate in a wide variety of semi-complex technicalassignments to supportthe manufactureofimmunochemistry diagnostic tests for the cardiac market.The position involves systematictroubleshooting of complex reagent manufacturing formulations and processesboth in individual and team-based projects.The incumbent will be responsible to helpwrite and execute validationplans, lead root-cause analysis efforts, and identify/implement process/equipmentimprovements.This person must be highlycompetent at planning/executing complex lab studies and utilizing specializedtesting techniques.Must also be able toanalyze, interpret, and present complex data for review and summarize resultsin a technical report.The candidatemust be capable to function as a project manager for our cardiac product lineas needed, leading multiple cross-functional team workstreams with regular supplychain management updates. The medical device industry is highly regulated, andthe candidate must be able to support compliance with ISO and FDA requirements.Major tasks and responsibilities:·Conductvalidation and verification activities to ensure project completion withinexpected parameters and time frame.·Designand conduct experiments to identify process issues related to undesirablereagent or manufacturing performance, and identify resolutions for thoseissues.·Plan, conduct,analyze, and document experiments necessary to improve manufacturing processcapability and reduce costs associated with paper-based reagent production.·Leadcross-functional manufacturing support team and mentor junior biochemists.·Functionas project manager for cardiac marker product line initiatives as needed.·Collaboratewith R&D personnel on product design changes and become a subject matter expertwith respect to cardiac product reagent chemistry.·Lead root-causeinvestigations and drive implementation of those solutions to improve reagent performanceand manufacturability.·Able todesign complex experiments, execute test protocols, and analyze/interpret theirresults.·Applyprincipals of lean manufacturing and support continuous improvement activitiesto meet quality, cost and supply requirements.·Effectivelycommunicate (oral and written) work progress in both intra- andinter-departmental team forums.·Providewell-written, coherent progress updates, validation documents, study protocols,and technical reports.·Participatein supplier and internal audits; able to interact effectively with keysuppliers.Qualifications:·PreferredBachelors or Masters in Biochemistry or Chemistry.·Min 5years' experience, preferably in a medical device or related industry·Expertiseand deep knowledge in protein chemistry·Strengthin one or more of the following areas: Clinical Chemistry, Immunoassays, Biostatistics,Manufacturing Process Capability, and Computer Science.·Provenexperience in successful root cause analysis and resolution of manufacturing ordesign issues.·Demonstratedcompetence in experimental design and data interpretation.·Workingknowledge of basic statistics necessary to develop sampling plans and analyzedata.·Able toprepare technical reports and testing protocols per approved department andsite procedures.·Must bewell versed in Office Applications, particularly Excel and Access; experiencein SAP or Minitab desired.·Sometravel (<10%) may be required.Othercharacteristics of the successful candidate:·Veryorganized, detail-oriented·Highlyself-motivated·Able towork independently·Excellentanalytical, communication, writing, and problem-solving skills·Effectiveand influential in his/her interactions in team-based assignments·Able towork well with personnel from different departments, and experience levels·LeanManufacturing and CAPA Investigator experience·Demonstratesgood laboratory and manufacturing practices·Workingknowledge of manufacturing process performance trending·Expertiseand deep knowledge in protein chemistryAt 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/careersIf you wish to find out more about the specific division before applying, please visit: https://usa.healthcare.siemens.com/about.Beware of Job ScamsPlease beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Career site:https://jobs.siemens-healthineers.com/careers"Successful candidate must be able to work with controlled technology in accordance with US export control law." 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