Siemens Careers

Biochemist, Sr

East Walpole, Massachusetts
Manufacturing

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English (US)

Job Description

Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 234404
Primary Location: United States-Massachusetts-East Walpole
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 15%

Division Description:

Division Description
Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.

With 45,000 employees Siemens Healthineers is one of the world’s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers’ needs. So that more people can have a life that is longer, richer, and more filled with happiness.

For more information, please visit:
http://www.usa.siemens.com/healthcare


Job Description:

At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably.  A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
 
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
 

 

 

Sr. Biochemist
 
Position Overview
 
This Sr. Biochemist position is at Walpole Technical Operations for the China manufacturing project. The successful candidate will play a key role in immunoassay Design History File (DHF) gap analysis and mitigation as a technical expert. The position will also participate in the training of Siemens colleagues who will be based in China in order to learn Technical Operation job functions and responsibilities, and will support the China Technical Operations group investigation and troubleshooting into pilot manufacturing issues. 
 
Responsibilities
  • Work in the cross-functional team to provide technical support for immunoassay Design History File (DHF) gap analysis and mitigation as a subject matter expert.
  • May lead a team or directly perform technical studies as required by the mitigation plan.
  • Responsible for planning and designing of technical studies; develop and write protocol and reports; coordinate and perform data analysis; summarize testing results, and present studies in cross-functional teams.
  • Review historical data to prepare regulatory submission required for critical raw materials, reaction systems, and manufacturing processes in immunoassays.
  • Contribute to developing Product Technical Requirement (PTR) and Product Performance Evaluation (PPE) strategies, and write the technical sections of regulatory dossier as required by the China manufacturing project.
  • Lead or participate in the design verification activities; troubleshoot and solve technical issues.
  • Support Risk Management activities such as developing dFMEA and pFMEA.
  • Participate in training of Chinese colleges to support the China Technical operations group investigations into manufacturing issues.
  • Collaborate with other team members and support cross functional team activities.
Required Knowledge/Skills, Education, and Experience
  • BS, MS or PhD in Medical Technology, Biology, Biochemistry, Immunology, Life Science or related fields.
  • 10+ Years job related experience.
  • Strong background and experience with automated immunoassay analyzers and/or ELISA and chemiluminescent technology.
  • Proven ability to interpret data, troubleshoot and resolve the technical issues.
  • Strong work ethic, be highly motivated, and work independently with high energy.
  • Strong leadership skills, excellent written and communication skills.
  • Strong statistical skills (ANOVA, linear regression and t-test) and proficiency with statistical software (Minitab, SAS).
  • Proficiency with Microsoft Office Applications.
Preferred Knowledge/Skills, Education, and Experience
  • Advanced degrees preferred.
  • Knowledge and experience in IVD product registration.
  • Experience with immunoassays, including automated immunoassay analyzers, ELISA and chemiluminescent technology.

 

 


Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.



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