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
- 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
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