Scientist I - GMP Operations

It’s an exciting time to join us!

The Andelyn Biosciences’ Manufacturing group is seeking a motivated individual to join our growing team as a GMP Operations Scientist I.

The GMP Operations Scientist I is responsible for supporting all aspects of Good Manufacturing Practices (GMP) production in the Clinical Manufacturing Facility (CMF). Working in collaboration with the Manager of GMP Operations and staff. The Scientist I will provide hands on assistance for all day-to-day GMP production operations, including execution of production processes, documentation, as well as facility and equipment maintenance. The Scientist I will support production efforts to deliver all products in a timely, compliant, and fiscally responsible fashion by following appropriate Standard Operating Procedures (SOPs) for manufacturing biological products. 

Schedule: Full-time (Benefits Eligible)  

Location:  Central Campus 

                  575 Children's Crossroads

                  Columbus, OH 43205 

Under the guidance and direction of the Associate Director - Manufacturing essential functions of the Scientist II - Manufacturing include at a minimum:

• Works in collaboration with GMP Management and Staff to cultivate and enact the strategic direction of the GMP area including determination of schedule and project timelines/capabilities
• Maintain Eukaryotic cell line
• Utilize biochemical techniques to purify vector
• Supports GMP resources and supply chain including maintaining materials inventory control to meet production goals
• Performs daily operational activities related to the GMP manufacturing of biological products, by executing production processes and assuring the proper documentation of GMP activities
• Assists in process documentation review, revision, remediation, and process change controls
• Learn the skills necessary for performing critical operations in the GMP manufacturing facility
• Develop the ability to lead auxiliary operations
• Adhere to good documentation principles and ALCOA in the support of all production activities
• Assists the GMP Management and staff with deviation investigations, OOS results and process troubleshooting
• Exercise discretion, judgment, and personal responsibility
• Demonstrate high level of integrity
• Maintain positive attitude
• Learn procedures under guidance of senior staff
• 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
• Display a high degree of attention to detail in all job functions
• 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
• Make decisions based on established procedures
• Remain adaptive to changes in schedule
• Other duties as assigned

Knowledge, Skills and Abilities required:

• Must possess relevant four-year degree, background in the life sciences, biotechnology or gene therapy industries preferred
• No minimum experience
• Experience in highly regulated field beneficial
• 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 collaboratively in a diverse as well as independently in inclusive work environment.
• Must possess a client-focused mindset in daily tasks
• Must be able to don PPE for extended periods of time (scrubs, gloves and full body cleanroom suit)
• Familiarity in eukaryotic cell culture techniques beneficial
• Familiarity in chromatography beneficial
• Strong aseptic technique preferred

Minimum Physical Requirements

• Sitting (0-66%)
• Walking/Standing/Stooping (100%)
• Independently lifting up to 50 pounds (33-66%)
• Talking on phone or in person (0-33%)
• Typing on a computer keyboard (25-75%)

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.    

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

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.