Nationwide Children's Hospital

Andelyn Biosciences - Senior Facilities Specialist

Posted Date 2 months ago(7/17/2020 9:26 AM)
Requisition ID
2020-24463
Category
Research

Overview

JOB POSTING – Senior Facilities Specialist

Full time Exempt

 

We are seeking a Senior Facilities Specialist -The Clinical Manufacturing Facility at Nationwide Children’s Hospital is an industry 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, 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 on the minds of every patient and their families. The Clinical Manufacturing Facility (CMF) is primarily a full service manufacturer of Adeno Associated Virus (AAV). We work with over 100 clients each year to manufacture AAV at development, toxicology, clinical and commercial quality. The CMF supports Gene & Cell Therapy, as well as Tissue Engineered Vascular Graft products. The Scientist/Specialist will perform assigned tasks to support current GMP processes in the CMF. Working in collaboration with leadership and senior staff, the Scientist/Specialist will perform day-to-day operations, including execution of experiments, production processes, documentation, as well as facility and equipment maintenance as applicable to specific work area. A Scientist/Specialist will support efforts to deliver all products in a timely, compliant, and fiscally responsible fashion by performing and documenting assigned work, following appropriate practices, and reading and following Standard Operating Procedures (SOPs) for the manufacture of biological products.

Responsibilities

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.

What Will You Be Doing?

  • Solving, correcting, preventing problems and performs tasks as assigned by leadership, as well as assigning tasks to junior staff.
  • Work to specific measurable objectives requiring operational planning skill with little direct supervision.
  • Leads and supports a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of team and goals.
  • Attention to detail in all job functions.
  • Documentation of all activities performed according to SOPs.
  • Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed.
  • Has fiscal responsibility.
  • Influence in hiring, development and related personnel processes.
  • Make decisions based on established procedures.
  • Demonstrate high level of integrity.
  • Operate within the Quality Management System applicable to the manufacture of phase appropriate material in the CMF.
  • Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
  • Maintain positive attitude.
  • Other duties as assigned.

Qualifications

What Are We Looking For?

To fulfill this role successfully, you must possess these minimum qualifications and experience:

  • Requires a relevant four-year degree.
  • Requires at least six years of relevant experience or relevant masters and two years of experience or relevant PhD.
  • Experience in biologics or gene therapy required. Experience in highly regulated field preferred.
  • Highly skilled in Microsoft Office products including data interpretation and reporting.

 

 

Your Benefits, Your Wellness:

As an employer, Nationwide Children’s recognizes the importance of the benefits we offer. We also recognize the importance of balancing your work and personal needs.  Our benefits and Employee Wellness package is designed to:

  • Empower you to be a conscientious health care consumer through educational and wellness activities
  • Establish a work environment that promotes health and well-being
  • Support your financial protection and security in retirement
  • Most of our positions are benefits’ eligible from day 1.

 

Minimum Physical Requirements:

  • Needs to be able to lift 20-30 pounds occasionally (0-33% of the time).
  • May require ability to aseptically gown or wear other PPE on regular basis.
  • Must be able to stand for extended periods. 

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