Senior Biochemist-Technical Operations

Job Description

The successful candidate will participate in a wide variety of semi-complex technical assignments with respect to systematic troubleshooting and support of manufacturing and supplier issues for paper-based diagnostic tests.  The incumbent will be responsible to help write and execute validation plans, lead root-cause analysis efforts, and identify and implement process/equipment improvements.  This person must be highly competent in bench-scale solution preparation and specialized testing techniques.  Must also be able to analyze, interpret, and present coherent data for review and summarize results in a technical report.  The medical device industry is highly regulated, and the candidate must be able to function and support the requirements of the regulations.

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 Marketing/Global Service and 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.

·        Must be able to verbally communicate clearly and directly with colleagues and 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.

Qualifications:

·        Preferred Bachelors or Masters in Chemistry; will consider degree in other science or engineering, with a concentration in Chemistry.

·        Min 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 data analysis reports and testing protocols.

·        Must be well versed in Office Applications, particularly Excel and Access; experience in Matlab, 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 experience

·        Demonstrates good laboratory practices



Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Experienced 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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