Established as an affiliate companyof Nationwide Children’s Hospital and its Research Institute, AndelynBiosciences is a product of Nationwide Children’s Hospital’s success inclinical manufacturing and gene therapy. Nationwide Children’s Hospital isinvesting in Andelyn Biosciences to support Phase III studies for clinicalmanufacturing with these capabilities scheduled to begin in the third quarterof 2020. Andelyn Biosciences is targeting 2023 for the completion of a state ofthe art, GMP, manufacturing facility capable of early stage development throughcommercial scale manufacturing.
What Will You BeDoing?
- 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.
What Are WeLooking For?
To fulfill this role successfully,you must possess these minimum qualifications and experience:
- Relevant four-year degree OR relevant master’s 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.
- 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%)