Nationwide Children's Hospital

Andelyn Biosciences - Quality Control Scientist I

Posted Date 2 months ago(7/16/2020 1:21 PM)
Requisition ID
2020-24439
Category
Research

Overview

JOB POSTING – Quality Control Scientist l

Full time 2nd shift

 

We are seeking a Quality Control Scientist l - The Clinical Manufacturing Facility specializes in the cGMP production of recombinant adeno-associated virus (rAAV) vectors for use by faculty at Nationwide Children's Hospital, The Ohio State University Medical Center and external collaborators. The primary responsibility for the Scientist 1 Quality Control position is the execution of various molecular biology, chemistry, microbiology, and protein chemistry assays to support quality control testing of manufactured products. All work is conducted under strict adherence to standard operating procedures and following good documentation practices. Secondary responsibilities include assist in peer review of routine QC testing documentation, deviation documentation, SOP generation or revision, and other tasks needed to support the primary responsibilities.

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?

  • 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.
  • Attention to detail in all job functions.
  • Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed.
  • Identifies problems and performs tasks as assigned.
  • Work under general supervision of senior staff and leadership.
  • Works in diverse and collaborative team environment utilizing clear communication to deliver high productivity and contributes to the success of team and goals.
  • Documentation of all activities performed according to SOPs.
  • Make decisions based on established procedures.
  • Nominal fiscal responsibility. 
  • Exercise discretion, judgment and personal responsibility.
  • Demonstrate high level of integrity.
  • 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:

  • Relevant four-year degree in a scientific related field.
  • No minimum experience.
  • Effective communication and interpersonal skills required.
  • Experience in highly regulated field preferred
  • Skills in operating a personal computer, and word processor.
  • Must be familiar with various software packages (e.g., Word, Excel, PowerPoint).

 

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:

  • Sitting for extended periods Constantly (67-100%)
  • Talking on the phone/in person Constantly (67-100%)
  • Typing on a computer keyboard Constantly (67-100%)
  • Standing/walking Occasionally (0-33%)

 

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.

 

EOE M/F/Disability/Vet

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