Laboratory Manager, Assay Development - (R1024428) in Research Triangle Park, NC at IQVIA™

Date Posted: 5/2/2018

Job Snapshot

Job Description

Launched in 2015, Q2 Solutions is a leading global clinical trials laboratory services organization. We help biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. Q2 Solutions is a quality driven, responsive partner with strong global experience and deep scientific and medical expertise. The Q2 Solutions joint venture was formed by Quintiles and Quest Diagnostics, combining the best of each parent organizations clinical trials laboratory services capabilities.

Description

SUMMARY:
The Assay Development laboratory manager will be responsible for onboarding, validating, and maintaining genomics laboratory equipment, developing procedures, managing inventory, sample specimen storage, training assay development staff, driving process improvement, and supporting assay development team efforts. The ideal candidate will have a molecular biology background, strong organizational skills, leads by influence, and understanding of lean methodologies.

RESPONSIBILITIES:
  • Maintains research and clinical laboratory equipment by establishing quality standards and developing operations, quality, and troubleshooting procedures by collaborating with assay development staff; ensuring assay development staff compliance; validating instrument performance; arranging equipment replacement, service, and repair.
  • Maintains laboratory supplies inventory by checking stock to determine inventory levels; anticipating needed supplies; placing and expediting orders for supplies; verifying receipt of supplies.
  • Onboards assay development staff by providing laboratory training on handling of clinical samples and equipment usage.
  • Tracks specimen/sample storage location and movements that provide an auditable chain of custody.
  • Maintains professional and technical knowledge through educational training; establishing personal networks; participating in professional societies; maintaining awareness of latest technologies.
  • Drives improvements to processes using 5S, Kaizen, Problem Solving, and/or Value Stream Mapping. Demonstrated experience using 5S preferred.
  • Contributes to assay development team effort by accomplishing related results as needed.
  • Liaisons with other functions such as Operations and Quality.

Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
  • Hands-on experience with high throughput DNA Sequencers, and genotyping and Real-Time PCR equipment.
  • Experience in inventory management, equipment validation and maintenance, developing and improving processes.
  • Strong oral and written communication skills; demonstrated ability to present and write technical Information and train staff on molecular methods.
  • Excellent computer skills including proficiency with Microsoft Office applications, as well as experience in bio-statistical software as needed.
  • Demonstrated understanding of molecular biology, analyze data, and solve technical problems.
  • Clinical lab testing preferred but not required.
  • Ability to effectively navigate on-line biological databases including NCBI (e.g. PubMed, Entrez, etc.), EMBL, Sanger, etc.
  • Strong organizational skills.
  • Effective communication skills.
  • Ability to effectively execute multiple tasks.
  • Able to drive problem solving activities within area of work. Uses Pareto charts, 5 Whys, fish bone diagrams to get to root cause.
  • Strong analytical skills.
  • Leads using influence.
  • Strong interpersonal skills and an ability to establish and maintain effective working relationships with co-workers, managers, and clients.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE:
  • BS/MS Degree or educational equivalent in cell biology, molecular biology, cancer biology, pharmacology or related field with 5 years relevant experience; or equivalent combination of education, training and experience.

 
EEO Minorities/Females/Protected Veterans/Disabled

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.


Job ID: R1024428