Associate Director – Test Implementation

Associate Director – Test Implementation

Requirements

• Bachelor’s Degree in life sciences or related field.
• 10+ years of experience in the life sciences industry.
• 5+ years of experience working in a molecular diagnostic or clinical laboratory, or 5+ years in a molecular diagnostic R&D role.
• 6+ of leadership experience with direct responsibility for performance management, development, coaching, hiring, and training direct reports.
• Demonstrated advanced proficiency or coursework with molecular biology techniques and Real-Time- polymerase chain reaction (PCR) Assays OR next-generation sequencing techniques.
• Demonstrated advanced knowledge of clinical lab regulations such as College of American Pathologists (CAP), clinical laboratory improvement amendments (CLIA), invitro diagnostic regulation (IVDR), and food and drug administration (FDA).
• Demonstrated understanding of statistical and mathematical methods in biology or genetics.
• Advanced data analysis skills and analytical aptitude.
• Proficiency in Microsoft Office programs, such as Word, Excel, PowerPoint, Outlook, Access, and OneNote.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Responsibilities

• Lead and guide other scientists in troubleshooting of customer issues through root cause investigation, experiment design, study execution, data analysis, and reporting.
• Act as Incident Commander, the single point-of-contact and responsible party for a critical investigation to manage patient safety, operational mitigation, and ultimate resolution through prompt action, cross-functional partnership, and thorough communication.
• Conduct efficient and effective bench level experiments within several product areas and guide other scientists in the same.
• Prepare detailed technical protocols for investigation, review and supervise creation of technical protocols of other scientists.
• Prepare technical experiment reports with all technical specifications and information to present to Director+ audiences and project teams.
• Lead training program development for internal and external customers.
• Effectively manage, support, and guide your team including, but not limited to, delegating tasks and responsibilities, assessing employee performance and providing helpful feedback and training opportunities.
• Consistent demonstration of exceptional leadership qualities, including, but not limited to the ability to attract and retain the best team, foster a culture of high performance, lead with integrity, humility, accountability, and courage, and set a clear vision to energize teams towards the future.
• Provide business justification, lead, and report effectiveness of individual improvements in processes and products.
• Draft and distribute the content of customer communications, customer notifications, and technical or service bulletins, review, edit, and approve such content created by others.
• Effectively represent voice of the lab customer to cross-functional stakeholders including Development, Marketing, Finance, IT, and Quality for new products and revisions to existing products.
• Identify gaps in processes, make recommendations, and implement change.
• Develop or participate in publication strategies and overall technical communications within Exact.
• Train and mentor team members, taking responsibility for their success and the quality and accuracy of their work products.
• Summarize and document troubleshooting activities or technical summary for Director+ audiences.
• Ability to communicate clearly, frequently, and accurately in person, via the telephone, or by email.
• Ability to work independently.
• Apply advanced analytical and troubleshooting skills.
• Apply strong communication and organizational skills.
• Apply high complexity problem-solving abilities to provide technical input, design experiments, propose product enhancement ideas and voice of customer (VOC).
• Ability to maintain confidentiality of sensitive information.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work designated schedule.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to work on a computer and phone simultaneously.
• Ability to use a telephone through a headset.
• Ability to travel 35% of working time away from work location, may include overnight/weekend travel.
• Maintain regular and reliable attendance.
• Receive and document incoming customer communications.
• Work cooperatively with the technical services team and internal functional departments to troubleshoot and resolve customer questions or requests related to reagents, consumables, and assay issues.
• Support and comply with the company’s Quality Management System policies and procedures.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.

Preferred Qualifications

• Advanced degree (Ph.D., M.S., etc.) in biology, chemistry, physics, engineering, or a related field.
• 15+ years of experience in troubleshooting molecular diagnostic tests.
• Demonstrated proficiency in molecular biology techniques and Real-Time- polymerase chain reaction (PCR) Assays and next-generation sequencing techniques.