Senior Quality Scientist - Reagent Manufacturing - Immunoassay

Job Description

Sr. Scientist – Quality Control

Position Overview:

Are you the right scientist to work in a fast paced manufacturing environment with cross-functional focus?  Would you enjoy working on a team developing one culture based on trust, accountability, ownership, and world class performance? We are looking for a candidate who will be involved in supporting a newly established reagent manufacturing system as well as future integration projects within an Immunoassay product line. Come join our team and embrace the Siemens belief of “Know now, live better…”

Responsibilities:

  • Performs routine to complex tests and analyses according to established procedures.
  • Performs release activities and inputs associated data into SAP.
  • Performs complex tests or investigations pertaining to the development of new designs, methods, materials, or processes and investigates possible application of results.
  • Troubleshoots and resolves complex problems.
  • Completes a wide variety of complex technical assignments.
  • Obtains, correlates, and analyzes technical information needed to accomplish complex tasks.
  • Performs mid to complex analysis of raw data to determine experimental results and learns and implements best practices for data analysis.
  • Completes the preparation of reports, charts, graphs, and other documents and advises senior staff.
  • Reviews and approves related inputs such as complex drawings and specifications prepared by technical support personnel.

·      Plans with support mid-complex to highly complex experiments, including planning reagents and consumables required.

·      May lead meetings when assigned to continue projects- either for scheduling, troubleshooting, or status collection.

·      Leads development of assay parameters (test methods) for use on analytical instrumentation.

·      Participates in Design Control activities: Verification and Validations, testing and documentation- from Design Change documentation to authoring protocols and reports with some support as required.

·      Works collaboratively in a cross-functional team of Engineers, Manufacturing and Scientists from multiple groups.

Required Knowledge/Skills, Education, and Experience

·      B.A. or B.S. Degree in biology or biochemistry with over 6 years of industry experience.  Masters with 4 years industry experience. PhD with 2 years industry experience.

·      Thorough understanding of 21 CFR Part 820 regulations and ISO 13485 standard requirements, and all other MDSAP country regulations for medical device or pharmaceutical operations.

·         Multiple years of experience with multiple reagent kits for immunoassay based technologies, specifically involving a troponin assay.

·      Experience working with analytical instrumentation, reagent systems, including testing repetitively.

·      Experience planning experiments with multiple variables – may have been DOE.  This includes identifying all factors and determining replicates needed for statistical significance.

·      Experience identifying and troubleshooting process, material, or equipment problems to minimize    down time and recommend solutions. 

·      Experience performing data analysis as well as formal report writing.

·      Experience creating and modifying testing protocols and supporting documents.

·      Familiar with statistical analysis tools.

·         Familiar with working in SAP.

·      Able to work independently and manage tasks assigned on schedule.

·      Strong scientific, communication and organizational skills are a must.

·      Should be comfortable with handling bio-hazardous materials.

·      Travel required may be 0-20% depending on Project.

·         Experience with multiple reagent kits for immunoassay based technologies.

   



Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Mid-level Professional

Job Type: Full-time



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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 unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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