General Description

 

The Specialist I will complete the principal duties and responsibilities outlined below. Working in collaboration with leadership and senior staff, the Specialist I will participate in the execution of critical cleanroom contamination control strategies. Activities will include the performance of status change activities, document review, materials oversight, execution of projects/tasks, and reviewing technical and procedural documents. The Specialist I will support efforts to deliver all products in a timely, compliant, and fiscally responsible fashion.   

Locations:  Andelyn Plasmid's Center

                    575 Children's Crossroads

                    Columbus, Ohio 43215

Principal Duties and Responsibilities

 

·       Execute and coordinate cleanroom status change activities to ensure all critical tasks are executed after manufacturing campaigns/lots and before initiation of subsequent manufacturing activities

·        Review documentation for completion and accuracy, file documentation for timely retrieval

·        Monitor in-use inventory of critical cleanroom PPE and/or cleaning/disinfection supplies, coordinate supply ordering/stocking.

·        Identify gaps in facility operation processes that may increase contamination risk. Report possible issues to Facility Management.

·        Provide introductory, ongoing, and on-demand training for cleanroom operators

·        Participate in cross-functional quality event investigations related to facility operations and status change as necessary

·        Exercise discretion, judgment, and personal responsibility

·        Demonstrate a high level of integrity

·        Maintain a positive attitude

·        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 the general supervision of senior staff and leadership

·        Works in a 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

·        Other duties as assigned

Knowledge, Skills, and Abilities Required

·        Must possess a relevant four-year degree, background in the life sciences, biotechnology, or gene therapy industries preferred

·        No minimum experience

·        Understanding of GxP is desirable

·        Experience in highly regulated field preferred

·        Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change

·        Must be literate in Microsoft Office (PowerPoint, Excel, Word)

·        Ability to work independently as well as collaboratively in a diverse and inclusive work environment.

·        Must possess a client-focused mindset in daily tasks

·        Must possess prior experience handling confidential information and the ability to maintain confidentiality

 Minimum Physical Requirements

 

·        Occasionally Sitting

·        Constantly Walking/Standing/Stooping

·        Occasionally Talking on the phone or in-person

·        Occasionally Typing on a computer keyboard

·        Ability to wear cleanroom gowning and other PPE regularly

 

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, 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.      

 

Andelyn Biosciences is committed to a diverse and inclusive workplace. Andelyn is an equal opportunity employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or another legally protected status. 

 

Andelyn may require proof of COVID-19 vaccination prior to your first date of employment depending on whether your role would require performing under federal contracts on behalf of Andelyn.  If required and in accordance with applicable federal guidelines, either proof of completion of an approved vaccine series will be required upon hire, or a religious and medical exemptions may be considered depending upon the specific job duties