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.


The Scientist II- Plasmid Operations role will learn all aspects of DNA plasmid production.  They will master procedures and be able to lead and coordinate their execution. The Scientist 2 will be responsible for adhering to cGMP principles while overseeing production teams in the production of DNA plasmids.  They will work with Management and Senior Staff to plan and execute operations goals.


What Will You Be Doing?

  • The Scientist 2 will be responsible for assisting and leading operations in the support of the production of plasmids used for basic research and toxicology studies.
  • Additional responsibilities include coordinating and leading operations in the formulation of critical solutions used in the production of plasmids for research studies.
  • Contribute to material inventory tracking.
  • Learn all areas of operation involved in our production scheme.
  • Provide training to staff.
  • Anticipate, solve, correct, and prevent problems including error trending and CAPA implementation.
  • Draft and revise SOPs and other process documents.
  • Uphold a clean and safe work environment.
  • Maintain compliance with applicable regulatory requirements for gene therapy products.
  • Perform tasks as assigned by leadership, as well as delegating assignments to junior staff.
  • Ability to work with some independence based on applicable experience.
  • Adhere to good documentation principles and ALCOA in the support of all production activities.
  • Has fiscal responsibility for areas of oversight.
  • Other duties as assigned to meet the organization’s goals.
  • Support a cohesive, high- performing team.
  • Limited responsibility for inspection outcomes
  • May require some travel
  • Limited involvement in customer relations.


What Are We Looking For?

To fulfill this role successfully, you must possess these minimum qualifications and experience:

  • Relevant four-year degree OR relevant Masters OR relevant PhD in microbiology, molecular biology, biochemistry or related field required.
  • Four years relevant (w/4 YR degree) OR two years (w/Masters).
  • Experience in the manufacture of biologics or gene therapy required.
  • Experience in highly regulated field preferred. (cGMP/ GLP)
  • Ability to work with highly confidential materials.
  • Familiarity with biochemical procedures used in biological manufacturing.
  • Experience with eukaryotic cells is essential.
  • Familiarity in USP, and ISO are beneficial.
  • Understanding of large-scale plasmid production is preferred.
  • Ability to lead teams of diverse backgrounds and experiences.
  • Experience in performing in highly skilled teams is preferred.

 

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 weight at 45lbs or greater (33-67%)


EOE M/F/Disability/Vet

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