DESCRIPTION

The Clinical Manufacturing Facility at Andelyn Biosciences is a Leading cGMP production facility dedicated to advancing the field of Gene and Cellular Therapy. Our Mission is to use our knowledge, resources, technology, and experience in the field of translational and regulatory science, in collaboration with our clients, to develop new, safe, and effective long-term treatments for diseases. There is no disease too rare and no challenge too difficult as we strive to make a difference with every product and to leave hope with every patient and family.

 

Established as an affiliate company of Nationwide Children’s Hospital and its Research Institute, Andelyn Biosciences is a product of Nationwide Children’s Hospital’s success in clinical manufacturing and gene therapy. Nationwide Children’s Hospital is investing in Andelyn Biosciences to support Phase III studies for clinical manufacturing with these capabilities scheduled to begin in the third quarter of 2020. Andelyn Biosciences is targeting 2023 for the completion of a state of the art, GMP, manufacturing facility capable of early stage development through commercial scale manufacturing.

The Operational Excellence Specialist is responsible for the continuous improvement of processes to reduce waste, increase efficiency and improve overall productivity throughout the organization. This role will serve as a subject matter expert in Lean Six Sigma principles, the DMAIC process, value stream mapping, 5S and visual management to reduce variability, eliminate waste and make processes more standardized and efficient. The Operational Excellence Specialist will lead and facilitate projects across the organization and work collaboratively with employees to create a culture of continuous improvement.

 

Schedule: Full-time (Benefits Eligible) 


Location: 

Central Campus 

700 Children's Drive

Columbus, OH 43205 

 

Under the guidance and direction of the Head of Supply Chain, essential functions of the Operational Excellence Specialist:

  • Serve as a subject matter expert in operational excellence through the utlization of lean six sigma tools and methodologies.
  • Identify opportunities for improvement and determine the categorization of the project (e.g. dedicated project team, Six Sigma Project, Kaizen event, etc.)
  • Prioritize projects based on impact, timeline and available resources.
  • Create project charters outlining the business need/justification, project scope, team members, deliverables, timeline and tracking of status.
  • Identify the right personnel, with the appropriate subject matter expertise, to participate on the project team.
  • Schedule and facilitate team meetings with clearly identified agendas, action items and documented meeting minutes.
  • Use the DMAIC process to reduce variability and implement sustainable improvements.
  • Implement 5S and visual management throughout the organization to promote awareness and standardization.
  • Analyze data to determine root cause, appropriate actions, effectiveness of improvements and realization of benefits.
  • Utilize process maps to establish current / future state workflows and to identify opportunities to make process more efficient and standardized.
  • Assist hands on with implementation activities, including change control, procedural updates, creation of forms, etc.
  • Ensure that improvements are fully implemented, sustainable and in compliance with GMP requirements.
  • Promote engagement across the organization to establish a collaborative culture of continuous improvement.
  • Establish and maintain a communication plan to inform the organization of project status, implementation of improvements and realized benefits. 
  • Develop lean six sigma training and mentor others to develop a continuous improvement mindset and culture.
  • Identify and align projects/improvements with associated metrics.  
  • Evaluate cost to determine budgetary impact and projected savings.
  • Perform in accordance with established policies, procedures, and techniques and utilize training, common experience or working knowledge related to the tasks performed.
  • Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
  • Utilizes clear and concise communication to ensure high productivity and contribution to the success of department goals.
  • Limited travel may be required.
  • Utilizes business acumen and considers business impacts in planning and problem solving.
  • Other duties as assigned.


Knowledge, Skills and Abilities required

  • Bachelor’s degree in related field with 5 years of work experience in operational excellence.
  • Sound knowledge of Lean Six Sigma tool and methodologies with the ability to both use in projects and teach others.
  • Six Sigma Black Belt certification and Lean experience is required.  
  • Effective communication and interpersonal skills required.
  • Proficient in all Microsoft Office Applications.


 Minimum Physical Requirements

  • Talking in person/on phone constantly (30-60%)
  • Project facilitation (20-30%)
  • Working directly with associates observing processes (20-30%)
  • Working at a computer constantly (30-60%)
  • Standing/walking occasionally (0-33%)

                                                                                   

 

EOE M/F/Disability/Vet

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