Luminex Job Posting: Senior Director/Vice President, Assay Research and Development – US

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/.

The Senior Director/Vice President of Assay Research and Development is responsible for managing a department focused on researching and developing new product ideas geared towards development of in vitro diagnostic products. The role necessitates close collaboration with departments across the company, including Marketing, Manufacturing, Regulatory, Quality and Technical Support. The position leads evaluation, feasibility, and product development activities of new products and technologies in accordance with Design Control Standards and Regulations. The Senior Director of Assay Research and Development is also responsible for administrative duties pertaining to the department as a whole, managing departmental project timelines, and preparing and monitoring the departmental fiscal year budget.

What you will do

• Direct and manage a department responsible for the development of new and improved products to meet corporate objectives and timelines
• Direct scientific managers and their group of scientists and associates in the development of new and improved in vitro diagnostic products in accordance with Quality System Requirements.
• In collaboration with marketing, establish effective pipeline plans and schedules to ensure timely progress of multiple products through all phases of new product development. Manage project team leaders from feasibility through development phase of product development and ensure effective knowledge transfer between feasibility and development groups.
• Provide department leadership for maintaining awareness of current advances in clinical diagnostic technology and literature (including regulations and standards) pertaining to nucleic acid based methods to ensure pipeline development plans capture all relevant considerations
• Provide leadership within Research & Development and across the organization in order to foster employee development
• Contribute towards management of GMP, GLP and GCP processes relating to design control, design change, and design transfer
• Direct verification and validation testing of new products in agreement with design control requirements.
• Contribute towards pre-submission activities and oversee clinical studies for the purpose of collecting data to support submissions to regulatory agencies (e.g. FDA, Health Canada)
• Oversee design transfer of products from Product Development to Operations
• Interact with Regulatory, Operations and Marketing to efficiently and effectively manage development, transfer and launch of a portfolio of diagnostic products
• Provide scientific expertise and support for on-market products. Lead troubleshooting activities and product design changes for on-market products.
• Role in Technology Assessment, Opportunity teams (review of new opportunities) and scientific development in the diagnostic field.
• Prepare departmental budgets and establish equipment and personnel needs to provide for product development.

Education Qualifications

• Ph.D. Ph.D. in Molecular Biology, Biochemistry or a related field. required

Experience Qualifications

• 10+ Years in scientific work in a biotechnology or other research environment. required
• 5+ Years Experience in nucleic acid amplification technologies (e.g. PCR), and molecular sample-to-answer systems. required
• 5+ Years leading and/or managing a team of engineers, scientists, associates and technicians in meeting department deliverables on a day-to-day basis required
• 5+ Years Experience in diagnostic assay development in a GLP/GMP environment required
• 5+ Years Experience preparing and working within budgets required
• 5+ Years Experience working in a fast-paced environment with rapidly changing priorities. required

Training and Skills

• Ability to advance projects through to completion, managing expectations and timelines, and meeting key milestones
• Demonstrates good judgment and good decision-making, sometimes quickly and with limited information available
• Capacity to manage several projects in parallel to ensure maximum productivity, without compromising quality, in pipeline development
• Exceptional verbal and written communication skills
• Ability to interact effectively with Senior Management
• Proven ability to lead and manage teams while maintaining a positive, energetic and collaborative culture

Standard Working Conditions

• Must work onsite at Luminex office – Frequently

Travel Requirements

• 10% with 5% international

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.