Biochemist Technical Operations @ Siemens – Biochemistry

Biochemist Technical Operations @ Siemens – Biochemistry

The successful candidate will participate in a wide variety of semi-complex technical assignments associated with the manufacturing of Diabetes diagnostic tests. The position involves systematic troubleshooting of complex reagent manufacturing formulations and processes both in individual and team-based projects.

Job Title: Biochemist -Technical Operations

Location: Mishawaka, United States of America

Department: Research & Development

Id: 267420


  • Preferred Bachelors or Masters in Biochemistry or Chemistry.
  • 3-5 years’ experience, preferably in a medical device or related industry
  • Strength in one or more of the following areas: Clinical Chemistry, Immunoassays, Analytical Chemistry, 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 SAS, 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

Position Purpose: 

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 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.
  • Provide technical support for OEM product/process investigations and improvements; customer complaint investigations; and customer service support information requests.
  • 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.

Biochemist Technical Operations

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