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Scientist I – GMP Operations - Viral Vector Manufacturing

Employer
Andelyn Biosciences
Location
Columbus, OH
Start date
Aug 10, 2022
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Job Details

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 Scientist I – Viral Vector Manufacturing.

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 by following appropriate Standard Operating Procedures (SOPs) for manufacturing biological products.  This role will be responsible for the production of viral vectors for gene therapy

 

Schedule: Full-time (Benefits Eligible)  

Location:  Central Campus 

                  575 Children's Crossroads

                  Columbus, OH 43205 

 

Under the guidance and direction of the Operations Manager, essential functions of the Supervisor include at a minimum:

  • Works in collaboration with GMP Management and Staff
  • Conduct manufacturing processes within GMP regulations to generate Viral Vectors for gene therapy
  • 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 Viral Vectors
  • 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
  • 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 required
  • 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
  • Strong aseptic technique preferred
  • Must be able to don PPE for extended periods of time (scrubs and full body cleanroom suit)

 

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 (100%)

 

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.

Company

Andelyn Biosciences is a biopharmaceutical CDMO Pioneering Solutions That Turn Hope into Reality™. With 20+ years of experience manufacturing viral vectors, Andelyn's scientific expertise for development and characterization has led to GMP material being produced for over 75+ worldwide clinical trials and 400+ cGMP clinical batches. Advanced quality systems, full regulatory support, and supply chain vertical integration help accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. The name "Andelyn" is a hybrid of two gene therapy pioneers who participated in pivotal Phase I clinical trials at Nationwide Children's Hospital. Andrew received the first U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006. Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. "Andelyn" combines their names, representing all the families who have courageously participated in the research that make today's gene therapies possible. Continuing Andelyn's patient-based mission, the company is opening two state-of-the-art commercial manufacturing and development sites. The Dublin-based Andelyn Development Center is set to open in May 2022 and will house Andelyn's preclinical and development services. The 185,000 square foot Andelyn Corporate Center located on The Ohio State University's Innovation District will open for production in mid-2022.  

Find Us
Website
Phone
614-580-8522
Location
515 E. Main St
Columbus
OH
43215
United States
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