ASSOCIATE SCIENTIST II

Job Scope

This position will be responsible for participating in the company's day to day Reasearch & Development activities which include design, execution and interpretation of scientific experiments and design and development of assays based on Luminex's technology platform and chemistries. Handles scientific experiments independently with minimal supervision.

Key Duties and Responsibilities

• Day-to-day “hands on” work in the laboratory including, planning and designing of experiments, generating, recording, and analyzing experimental data and maintaining laboratory notebooks. This involves working in Biosafety Level II laboratory with biological samples and nucleic acid extractions.

• Routinely, assemble and present data to departmental, project, and cross-site teams

• Significantly contribute to writing protocols and reports relating to feasibility, verification and validation of molecular tests under quality system requirements

• Interface across the organization and work closely with other functional groups, such as, Quality Affairs, Regulatory Affairs, Clinical Affairs, Design Transfer, Manufacturing, and Quality Control regarding priorities and timetables for deliverables

• Provide training and technical support to junior members of the team

• Assist in intellectual property development

• Conform to applicable Design Control regulations and standards

• Troubleshoot technical difficulties, as required

• Comply with the company quality policies and operating procedures

• Participate in the maintenance of general laboratory organization

• Performs other duties as assigned related to duties as assigned

Education, Experience, and Qualifications 

• Associate's Degree Community College 2-year diploma (technical) in biochemistry, biology, molecular biology, or a related scientific field combined with at least 5 years’ laboratory work experience in molecular biology or the biotechnology industry required or

• Bachelor's Degree Bachelor degree in biological/chemical or related scientific disciplines with 2 years relevant experience/training preferred or

• Master's Degree Master’s degree in biological/chemical or related scientific disciplines with no relevant experience/training preferred or

• 2+ Years Expertise in a variety of molecular and biochemical laboratory procedures required

• 2+ Years Knowledge of routine laboratory methods such as PCR, data analyses, specimen handling and processing, and experimental documentation required

• 2+ Years Working knowledge or experience with ISO 13485:2016 standards and FDA regulations preferred

• 2+ Years Prior medical device industry experience preferred

• Excellent oral and written communication skills. (High proficiency)

• Proficient in Microsoft Word, Excel, and PowerPoint programs. (High proficiency)

• Highly organized with proven time management and prioritization skills (High proficiency)

• Ability to work independently and with minimal supervision (High proficiency)

• Ability to handle the pressure of meeting tight deadlines (High proficiency)

• Excellent interpersonal skills with proven ability to work both in a team-oriented environment and independently (High proficiency)

• Knowledge of Design Control requirements as defined by the FDA Quality System guidelines (Medium proficiency)

• Mathematics and statistics aptitude. (Medium proficiency)

• Data analysis and technical writing aptitude. (Medium proficiency)

What we offer
Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.