Director - Assay Product Development - Luminex Corporation - Austin

Job description
This position leads and manages a department whose core focus is the development of new in vitro diagnostic products and biological detection assay products. The role necessitates close collaboration with both Research and Development and Design Transfer and Product Engineering to ensure effective and efficient transfer of new prototype products that require formal validation in accordance with Design Control Standards and Regulations. Job DescriptionThis position leads and manages a department whose core focus is the development of new in vitro diagnostic products and biological detection assay products. The role necessitates close collaboration with both Research and Development and Design Transfer and Product Engineering to ensure effective and efficient transfer of new prototype products that require formal validation in accordance with Design Control Standards and Regulations. The individual also directs timely transfer of products to Operations and Regulatory Affairs. The individual will also be responsible for administrative duties pertaining to the department as a whole and the preparation and monitoring of departmental fiscal year budget.


ESSENTIAL JOB DUTIES

Key Responsibilities of the Job:
Direct and manage a group of scientists and associates to develop new and improved in vitro diagnostic products and biological detection assays in accordance with Quality System Requirements and Corporate Mandates relating to product launch schedules.
Assume role as Technical Lead for key development projects within Biodefense and Protein Diagnostics and function as the key contact for peers within cross-functional departments (e.g. marketing, project management, engineering, and so forth)
Establish effective pipeline development plans and schedules to ensure timely progress of multiple products through all phases of development and transfer. Manage Assay Development team leaders as they execute on development plans.
Manage team leaders as they perform verification and validation studies for regulatory submissions; work with Regulatory Affairs and Clinical Affairs in the development and execution of validation plans.
Establish and manage the R&D budget for Biodefense and Protein Diagnostics Department.
Provide leadership within Assay Development and within a cross-functional mentorship program aimed at maintaining a corporate culture that fosters development of scientific expertise in Assay Development staff.
Manage GMP processes relating to a) design control; b) change control; c)product labeling; d) risk analysis.
Prepare departmental budgets and establish equipment and manpower needs (personnel time allocation) to provide for product development
Any other duties deemed necessary by management
Desired Skills and Experience
Competencies:

Building Effective Teams—builds a team with high morale and spirit; encourages open dialog
Business Acumen—knowledgeable about current and future issues that could affect the organization
Directing Others--plans, organizes, and distributes workload appropriately and communicates clearly
Managerial Courage—takes action on poor performers, recognizes high achievers, and does not hold back when things need to be said
Negotiating—can win concessions without jeopardizing relationships
Presentation Skills—effective in all settings such as one-on-ones, with small or large groups, with peers or bosses, etc.
Problem Solving— identifies complex problems and reviews related information to develop and evaluate options and implement solutions
Process Management—ability to simplify complex processes and to organize people and activities
Strategic Agility—ability to create competitive and breakthrough strategies and plans


Required Education/Training:

Ph.D. in Microbiology, Immunology Molecular Biology or a related field with a minimum of 8 years of related work experience in Product Development roles

Required Certifications/License/Special Skills:

Proven track record of successfully leading new product development resulting in regulated (FDA cleared/CE marked) products marketed in the US and internationally
They must be able to accurately evaluate the development timelines and risks associated with different product requirements and have successfully worked through the tradeoffs between speed to market and enhanced product performance
They must have organizational leadership ability, demonstrated resourcefulness, strategic and analytical thinking, and be oriented toward achieving objectives
They will be knowledgeable about the highly regulated nature of this business
Ability to manage a large group of scientists and technicians to develop assay-based products.
Ability to report laboratory findings in a concise manner, both verbal and in writing
Ability to analyze laboratory experiments for improvements
Ability to work error free and productively in a fast paced environment
Deep knowledge of assay design and development including assay optimization processes such as guard-band studies and alpha testing are critical
Direct personnel management of medium-sized groups and indirect management (e.g. project lead) of large, cross functional groups is important
Ability to direct laboratory experiments of high quality even under timeline stresses
Capacity to manage several projects in parallel to ensure maximum productivity, without compromising quality, in pipeline development

Required Work Experience:

Minimum of 8 years’ experience in diagnostic assay development, or related experience
Significant experience leading and managing a team of scientists and associates on a day-to-day basis
Experience in the definition or execution of clinical trials supporting product development or launch is required
Experience with FDA, ISO, CLIA, cGMP or equivalent systems within a product development setting
WORKING CONDITIONS
Must work onsite at Luminex office at least 80% of the time
Travel may be required approximately: 10% of the time
International travel may be required approximately 5% of the time
Possible exposure to biological or chemical hazard, extensive noise, and/or working with lasers
Work situations include dealing with people; working alone; making judgments and decisions; and directing, controlling or planning the activity of others
Physical Requirements:
Lifting/Use of Strength is Light (up to 20 pounds)
Climbing on the job is required: Occasionally--Up to 33% of the time
Kneeling on the job is required: Occasionally--Up to 33% of the time
Reaching on the job is required: Occasionally--Up to 33% of the time
Stooping on the job is required: Occasionally--Up to 33% of the time
Vision (Color) on the job is required: Occasionally--Up to 33% of the time

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