It’s an exciting time to join us!

The Andelyn Biosciences’ Quality Control group is seeking a motivated individual to join our growing team as a Project Manager - Quality Control.

The primary responsibility for the Project Manager - Quality Control is management of testing timelines to meet client requirements for in-process, release, stability, and R&D testing.  Project Manager will work with supervisors to ensure appropriate resources are available to support the required timelines to meet testing deadlines and adjust schedules as needed.  Project scheduling will require sufficient scientific experience to appreciate testing turnaround times as well as ability to multitask by technicians. 


Schedule: Full-time (Benefits Eligible)  

Location:  Central Campus 

                  575 Children's Crossroads

                  Columbus, OH 43205 


Under the guidance and direction of the Associate Director – Quality Control essential functions of the Project Manager - Quality Control include at a minimum:

  • 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.
  • Frequent involvement in audits
  • Frequent involvement in customer relations
  • Significant responsibility for inspection outcomes
  • Mentoring and professional development of staff.
  • Exercise crucial people skills.
  • 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.


Knowledge, Skills and Abilities required:

  • 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.
  • 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.

 

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


Andelyn Biosciences is currently operating under Executive Order 14042 that requires that employees of federal contractors and its affiliates be vaccinated against COVID-19, with some limited exemptions under the law.  As Andelyn is both an affiliate and will be a federal contractor, proof of vaccination status will be required prior to first date of employment.  Religious and medical exemptions may be considered depending upon the specific job duties and in accordance with applicable federal guidelines.


 


 

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