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.
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.
What Are We Looking For?
· Relevant four-year degree experience.
· 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).
Minimum Physical Requirements:
· Sitting for extended periods, Constantly (67-100%)
· Talking on the phone/in person, Constantly
· Typing on a computer keyboard, Constantly
· 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.