Nationwide Children's Hospital

Andelyn Biosciences - Operations Senior Scientist (Mammalian cell culture, and Prepared Solutions)

Posted Date 4 months ago(1/24/2020 8:23 AM)
Requisition ID
2019-21498
Category
Research

Overview

JOB POSTING - Operations Senior Scientist (Mammalian cell culture, and Prepared Solutions)

 

Full Time; Benefits Eligible

 

We are seeking a Senior Scientist for GMP Operations – This role will support the strategic goals of our team to produce transgenic adeno-associated viral vectors.  The Senior Scientist is responsible for leading and supporting the gene therapy team by overseeing both the mammalian cell culture. Responsibilities include coordinating the preparation and inventory maintenance of solutions made in-house for use in vector production processes. The Sr. Scientist will work with the junior staff to expand the knowledge base and skill set to further their work capacity.  Additionally, the Sr. Scientist will troubleshoot issues as well as trend errors and work with management to implement the appropriate CAPAs to drive process improvement.

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?

  • The Senior Scientist will be responsible for coordinating and leading operations in mammalian cell culture in the support of the production of viral vectors used in clinical trials.
  • Additional responsibilities include coordinating and leading operations in the formulation of critical solutions used in the production of viral vectors for clinical trials.
  • Anticipate and troubleshoot issues with the cell line and maintain inventory of reagents.
  • Trend data in relation to cell growth and performance.
  • Solving, correcting, preventing problems including error trending and CAPA implementation.
  • Uphold a clean and safe work environment.
  • Train and foster a highly functioning team of technicians in the production of phase 1/2a and phase 3 viral vector products.
  • Operate within the Quality Management System applicable to the manufacture of phase appropriate material in a clean room environment.
  • Maintain compliance with applicable regulatory requirements for gene therapy products.
  • Perform tasks as assigned by leadership, as well as delegating assignments to junior staff.
  • Maintain documentation of all activities performed according to SOPs.
  • Moderate involvement in audits, customer relations, and responsibility for inspection outcomes.
  • Has fiscal responsibility for areas of oversight.
  • Other duties as assigned to meet the organization’s goals.
  • Support a cohesive, high-performing team.

Questions about this opening or other career opportunities with Andelyn Biosciences? Email andelyncareers@nationwidechildrens.org to connect with a Talent Acquisition Partner.

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 Master OR relevant PhD.
  • Six years relevant (w/4 YR degree) OR two years (w/Masters).
  • Experience in the manufacture of biologics or gene therapy required.
  • Experience in highly regulated field preferred.
  • Ability to work with highly confidential materials.
  • Experience with eukaryotic cells is essential.
  • Familiarity in USP, and ISO are critical.
  • Must understand best practices in the preparation of aqueous reagents for use in phase appropriate clinical trials.
  • Understanding of AAV vector science is preferred.
  • Ability to lead teams of diverse backgrounds and experiences.

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 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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