SCIENTIST LEVEL 2

Luminex, a DiaSorin Company is seeking dedicated and talented individuals with a proactive and positive ‘can-do’ attitude to join our team. If changing the diagnostic landscape and revolutionizing patient care sounds like something you would like to be a part of, we invite you to apply today! Together, we can help healthcare providers improve patient outcomes, make a difference in fighting the COVID-19 outbreak, and tackle the world’s most pressing health issues. You can learn more about our values, mission, and vision by visiting our website https://www.luminexcorp.com/about-luminex/.

A Brief Overview
The Scientist Level 2 – DT & OMS (Design Transfer & On Market Support) is vital for all stages of the product development process and will lead transfer of new product designs to manufacturing beginning in the early stage of new product development through implementation and also include On-Market support activities post-product launch. This role's primary responsibilities will include coordination of the transfer of new product designs from R&D to manufacturing operations, including Bill of Materials (BOM), product design and configuration, product specifications, and QC test methods. The Scientist Level 2 – DT & OMS will be responsible for on-market product investigations and troubleshooting. This role will also lead the design, execution and interpretation of scientific activities for new method development and write reports, procedures and other documentation, including presenting to interdepartmental groups.

What you will do

• Participate in collaborative efforts with R&D and specific process subject matter experts for successful transfer of new product designs, including product requirements, material specification development, and release specification development
• Interface with cross-functional teams to ensure transfer of new products is completed according to agreed timelines
• Ensure effective engagement with design teams and fulfillment of early design transfer responsibilities for new and changed product designs from prototype through market release phases
• Ensure timely and effective knowledge transfer of science, technology, and application context behind new product designs being transferred into Reagent Manufacturing
• Lead the development and validation of QC test methods and release specifications
• Lead on-market product investigations through non-conformance investigations and CAPA processes
• Lead troubleshooting and root cause analysis activities
• Lead R&D production of applicable reagents prior to Design Transfer to manufacturing
• Collaborate with management in the release test methods and specifications for new products during design transfer activities and during market phase of released products
• Independently prepare and present study results internally to project teams and site management
• Perform engineering change control and document change control activities
• Contribute to manufacturing process validation efforts, as applicable
• Contribute to the development of process automation strategies, as applicable
• Independently design and conduct experiments in the laboratory and analyze scientific data in accordance with Good Laboratory Practices
• Provide technical leadership, assistance, advice, and support both to department management and other scientific personnel
• Participate in the maintenance of general laboratory organization
• Other duties as assigned

Education Qualifications

• Bachelor's Degree in biological/chemical or related scientific disciplines with 7 years of relevant experience/training required or
• Master's Degree in biological/chemical or related scientific disciplines with 5 years relevant experience/training preferred or
• Ph.D. in biological/chemical or related scientific disciplines with 2 years relevant experience/training preferred

Experience Qualifications

• 2 Years Quality Systems/Development, Process Improvement, Product Transfer, and/or product development focused experience in a relevant ISO 13485 and/or FDA regulated industry setting is required.
• 2 Year’s Experience in a GMP, GLP and/or FDA regulated environment required
• 3 Years of Quality Systems/Development, Process Improvement, Product Transfer, and/or product development focused experience in the molecular diagnostics industry preferred
• 2 Year’s Experience in leading troubleshooting and root cause analysis preferred
• 2 Year’s Experience in leading CAPA investigations and CAPA management preferred
• 2 Years Strong theoretical and practical experience with a variety of standard nucleic acid laboratory procedures (end point reverse transcriptase PCR, real time PCR) preferred

Training and Skills

• Excellent interpersonal skills with proven ability to work both in a team-oriented environment and independently (High proficiency)
• Excellent written and verbal communication skills (High proficiency)
• Strong organizational and problem-solving skills (High proficiency)
• Proficient in Microsoft Word, Excel, and PowerPoint programs. (High proficiency)
• Proven time management and prioritization skills (High proficiency)
• Ability to handle the pressure of meeting tight deadlines and adapting to rapidly changing priorities (High proficiency)
• Working knowledge of Design Control requirements as defined by the FDA Quality System guidelines (Low proficiency)
• Experience in Microsoft Project (Low proficiency)
• Mathematics and statistics aptitude (Medium proficiency)
• Data analysis and technical writing aptitude (Medium proficiency)

Licenses and Certifications

• Six Sigma certification preferred

Luminex Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability status of an otherwise qualified individual, citizenship status, membership or application for membership in a uniformed service, or any other protected characteristic or category protected by applicable law.

Job Type: Full-time