• Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.

• Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.

Job Scope
Lead day to day Research activities which include: design, execution and interpretation of scientific experiments and design and development of assays based on Luminex's technology platform and chemistries. The position requires high degree of independence to carry out scientific experiments, perform data analysis, and present findings to interdepartmental groups and management, as needed. The position will also serve as a resource for mentoring associates and entry level positions.

Job Duties & Responsibilites

• Provide technical leadership in design, optimization, execution and interpretation of scientific experiments required for development of highly accurate and reproducible assays in accordance with Good Laboratory Practices. This duty will involve laboratory bench-work including working in Biosafety Level II laboratory with biological samples and nucleic acid extractions.
• Effectively assist in managing a project from the evaluation phase through the product development lifecycle.
• Assemble and present data on a regular basis, to departmental, project, and cross-site teams
• Write and review protocols and reports relating to feasibility, verification and validation of molecular tests under quality system requirements
• Effectively serve as the technical leader on a core project team for feasibility and development of a new product through the manufacturing process, as needed
• Interact with senior management, as needed, to help resolve critical issues and concerns
• 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
• 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
• Other duties as assigned.

Education, Experience & Qualifications

• Bachelor's Degree Bachelor degree in biological/chemical or related scientific disciplines with 7 years of relevant experience/training required or
• Master's Degree Master's degree in biological/chemical or related scientific disciplines with 5 years relevant experience/training preferred or
• Ph.D. Ph.D. in biological/chemical or related scientific disciplines with 2 years relevant experience/training preferred or
• 5+ Years Expertise in a variety of molecular and biochemical laboratory procedures required
• 5+ Years Strong theoretical and practical experience with nucleic acid / protein isolation and detection methods required
• 2+ Years Working knowledge or experience with ISO 13485:2016 standards and FDA regulations preferred
• 2+ Years Prior medical device industry experience preferred

Training and Skills

• Knowledge of Design Control requirements as defined by the FDA Quality System guidelines (High proficiency)
• Mathematics and statistics aptitude. (High proficiency)
• Data analysis and technical writing aptitude. (High proficiency)
• 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)

Travel Requirements

• 10% domestic and international