Nationwide Children's Hospital

Andelyn Biosciences - Product Manager Quality Control

Posted Date 2 months ago(8/24/2020 9:19 AM)
Requisition ID
2020-24889
Category
Research

Overview

Full Time; Benefits Eligible 

 

We are seeking a Product Manager Quality Control

 

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.

Responsibilities

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.
  • Anticipating problems and removing obstacles to enable staff to perform tasks as assigned.
  • Work to specific measurable objectives requiring operational planning skill with little direct supervision.
  • Cultivate a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of department goals.
  • Developing and enforcing procedures and controls.
  • Approval of procedures established by junior staff
  • Has budgetary responsibility.
  • Moderate travel required.
  • Frequent involvement in audits
  • Frequent involvement in customer relations
  • Significant responsibility for inspection outcomes
  • Responsible for hiring, development and related personnel processes. 
  • Mentoring and professional development of staff.
  • Exercise crucial people skills.
  • Ability to manage and influence people in direct and lateral support structure.
  • Have significant latitude for making decisions for their operational or functional unit.
  • Drives timelines and development through broad influence.
  • Minimal interaction with legal services
  • Implements Quality Management System
  • 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 OR relevant Masters OR relevant PhD 
  • Eight years relevant (w/4 YR degree) OR four years with relevant graduate degree or certification. 
  • Experience in biologics or gene therapy preferred OR extensive experience in highly regulated field.
  • Prior supervisory experience is preferred
  • Effective communication and interpersonal skills required.
  • Skills in operating a personal computer, and word processor.
  • Must be familiar with various software packages (e.g., Word, Excel, PowerPoint).
  • Ability to work with highly confidential materials.

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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