DESCRIPTION

Andelyn Biosciences is an industry leading cGMP production facility dedicated to advancing the field of gene therapy. Our mission is to use our knowledge, resources, technology, and experience in the field of translational and regulatory science, to develop new, safe, and effective long-term treatments for diseases. There is no disease too rare and no challenge too difficult as we strive to make a difference with every product and to leave hope on the minds of every patient and their families. Andelyn is primarily a full-service manufacturer of Adeno Associated Virus (AAV).  We work with over 100 clients each year to manufacture AAV at development, toxicology, clinical and commercial quality.

We are seeking a GMP Scientist I – Operations.  The GMP Scientist I role will learn all aspects of the adeno associated viral (AAV) vector production and purification procedures.  They will work to master procedures and be able to work in a team environment to achieve their goals. The incumbent will be responsible for adhering to cGMP principles in the production and purification of AAV drug substances.  They will work with Management and Senior Staff to plan and execute operations goals.

 

 

Schedule: Full-time (Benefits Eligible) 

 

Location: 

Central Campus 

700 Children's Drive

Columbus, OH 43205 

 

Under the guidance and direction of the Associate Director of Manufacturing, essential functions of the GMP Scientist I – Operations:

  • The GMP Scientist I will be responsible for assisting in operations in the support of the production of viral vectors used in clinical trials.
  • Display high degree of attention to detail.
  • Contribute to material inventory tracking.
  • Learn all areas of operation involved in our production scheme.
  • Be able to learn and grow in the position.
  • Aid in problem solving.
  • Uphold a clean and safe work environment.
  • Operate within the Quality Management System applicable to the manufacture of phase appropriate material in a clean room environment.
  • Maintain compliance with applicable regulatory requirements for gene therapy products.
  • Develop the ability to identify problems and contribute to their resolution.
  • Follow directions provided by Senior Operations staff and Management.
  • Adhere to good documentation principles and ALCOA in the support of all production activities.
  • Has fiscal responsibility with regards to the work performed.
  • Other duties as assigned to meet the organization’s goals.
  • Support a cohesive, high- performing team.
  • Maintain positive attitude.

 

Knowledge, Skills and Abilities required:

  • Relevant four-year degree.
  • Ability to work with highly confidential materials.
  • Familiarity with biochemical principles. 
  • Experience with eukaryotic cells is preferred.
  • Familiarity in USP, and ISO are preferred.
  • Ability to work in teams of diverse backgrounds and experiences.
  • Skilled in MS Office suite.
  • Ability to demonstrate discretion, judgement and personal responsibility.
  • Demonstrate a high level of integrity.
  • Display attention to detail in all job functions.
  • Maintain positive attitude.

 

Preferred Skills:

  • Experience in a highly regulated field.

 

Minimum Physical Requirements

  • Sitting Constantly (0-33%)
  • Talking on the phone/in person Constantly (0-33%)
  • Typing on a computer keyboard Constantly (0-33%)
  • Standing/walking Occasionally (67-100%)
  • Lifting weights of 40lbs repeatedly (0-33%)
  • Ability to wear clean room PPE (100%)

                                                           

 

EOE M/F/Disability/Vet

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