Senior Planner, Quality Control (cGMP Gene Therapy)

Location
Durham, NC, US
Posted
Aug 26, 2020
Ref
5454
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 Senior Planner, Quality Control, is responsible for planning work for all QC activities to support testing, lean initiatives, investigations and other deliverables.

Responsibilities
  • Liaise with internal stakeholders and obtain manufacturing production plans in order to prepare schedules, plans and forecasts.
  • Creates capacity plans which meet business targets and optimize laboratory efficiency
  • Analyzes capacity and undertake appropriate calculations to estimate job requirements, in terms of labor, materials and resources.
  • Executes proven continuous improvement methods to pilot ideas, and deliver bottom line, quantified results.
  • Escalates any issues to manager or others in the organization particularly when there is risk which could prevent the organization meeting customer needs or where there are over capacity concerns.
  • Facilitates project and Tier meetings.
  • Manages a portfolio of multiple projects simultaneously and accurately and act as a primary contact for project team related information.
  • Facilitates deep process analysis through value stream mapping to identify obstacles due to ineffective laboratory processes and can lead Kaizen to improve flow and performance.
  • Eliminates unnecessary complexity in our work through streamlining our laboratory processes and simplifying and leveraging technology.
  • Builds trust and develop new relationships with internal and external clients to effectively collaborate and achieve successful outcomes at a site/global level.
  • Supports quality initiates projects, investigations, and audits.
  • Other related job duties as assigned.

Qualifications
  • Bachelor's degree in Chemistry, Biology or related sciences and 5 years of relevant experience in GMP testing laboratory with 2 years of project lead experience.
  • Strong communicator, both verbal and written, with the ability to influence across functions and at all levels of an organizations
  • Strong understanding of cGMP regulations.
  • Demonstrated organized and structured thinking and execution, with the ability to manage multiple tasks simultaneously and adjust priorities as needed in order to meet deadlines, demonstrating a high level of independent judgment and proactivity.
  • Demonstrated ability to support laboratory management with experience in project management methodologies.
  • Strong problem-solving, organizational, analytical and critical thinking skills.
  • OpEx and Lean experience preferred.
  • Ability to present and communicate complex ideas clearly, concisely and easily understandable to stakeholders.
  • Approximately 10-15% travel.


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.