Laboratory Operations Coordinator

Location
Durham, NC, US
Posted
Aug 24, 2020
Ref
5371
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.

The Laboratory Operations Coordinator is responsible for managing and tracking day to day tasks associated with the Technical Research and Development Laboratory.

Responsibilities
  • Works with multiple functions and groups to ensure the laboratory achieves and maintains the pace of experimental regimens necessary to support the characterization of our commercial and clinical products.
  • Develops and maintains the laboratory experimental schedule.
  • Works with Site Supply Chain and Facilities organizations to ensure reliable supply of consumables and single use systems as well as raw materials, and manages of select elements of the overall electronic laboratory information infrastructure to ensure the compliant flow of data and information in the support of technical documentation generation flows.
  • Other duties relating to the daily operations of the laboratory may include sample shipping and coordination, and equipment maintenance coordination or focused vendor engagement to resolve potential supply issues.
  • Provides cross-functional engagement as they partner with Manufacturing, Quality, Engineering, and Supply Chain around scheduling/timing of a variety of operational activities.
  • Builds and maintains both a Laboratory Operational Macro Schedule (to the level of unit operation sequence and timing) as well as a laboratory micro-schedule (to the level of daily tasks and shift assignments as needed).
  • Works with network subject matter experts (SMEs) and Supply Chain Operations staff to ensure the Bill of Materials (BOM), minimum order quantities, component master data and safety stock is continuously maintained (considering new/modified processes and technologies) for all disposable components supporting daily lab operations.
  • Orders single use components and raw materials as well as small lab equipment.
  • Coordinates with Quality Control, Facilities and materials suppliers to ensure raw materials (e.g. process gasses, de-ionized water, cell culture media, downstream buffers) are continuously available in sufficient quantity and release status (e.g. released, quarantined) to support uninterrupted experimental regimens.
  • Supports the development, maintenance, and orchestration of electronic laboratory information systems providing requirements to developers (with assistance from laboratory staff), expertise in systems operation and training to new laboratory personnel on the operations of systems such as Electronic Laboratory Notebooks &/or Laboratory Information Management Systems.
  • Works with Facilities and Engineering to ensure continued readiness of laboratory equipment and systems through activities such as coordinating calibration and preventive maintenance.
  • Tracks and trend select operational laboratory performance metrics to inform continuous improvement initiatives including coordinating with other labs in the network to complete investigation projects.
  • Identifies and implements supply chain optimization projects to improve business planning and customer service.
  • Tracks key metrics related to the health and performance of the laboratory supply chain and formulate key and effective improvement strategies for the area.
  • Proactively communicating status, issues and actions to senior management.
  • May work with area Environmental Health and Safety personnel to ensure the lab is in a compliant manner.
  • Other related job duties as assigned.

Qualifications
  • Bachelor's Degree in Business, Supply Chain Management, Program Management or similar discipline with 2 years of direct experience in complex, manufacturing and/or supply chain.
  • Experience with project management systems or other operational/organizational planning tools.
  • Strong teamwork and interpersonal skills.
  • Strong communication skills (verbal and written).
  • Ability to work effectively across different functions within the organization.
  • Experience and knowledge of organizational structure, workflow and operating procedures.


The level of this position will be based on the final candidate's qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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