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 Operations, Documentation Specialist.  This role is responsible for overseeing documentation reviews, revisions and progression through its life cycle.  The Specialist will act as a technical writer in drafting cGMP documents for use by the manufacturing teams.  They will also be responsible for tracking the life cycle of the documents used by the manufacturing teams. This individual will work in tandem with the Operations Scientists and Quality Assurance to meet production the goals of Andelyn.  A successful candidate will be self-motivated with excellent organizational and writing skills. 

 

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 Operations, Documentation Specialist:

  • The Documentation Specialist will be responsible for learning processes of up stream, down stream and support processes sufficient to apply working knowledge to execute technical review of process documents.
  • Creating documents from notes and discussions with the Manufacturing staff.
  • Draft new documents while working with Subject Matter Experts and other functional areas to draft and polish the documents for use in the Manufacturing areas.
  • Using experience to provide consistent voice for processing documents.
  • Initiate Change Control Reports for new documents.
  • Maintain compliance with applicable regulatory requirements for gene therapy products.
  • Adhere to cGMP regulations and written procedures governing processes.
  • Writing technical reports.
  • Trend documentation errors and drive improvement to the documentation to reduce these errors.
  • Provide training to staff.
  • Coordinate with other functional areas to assist in meeting production goals.
  • Demonstrates positive customer service skills.
  • Communicates issues/concerns to Supervisor/ Senior Manufacturing staff as needed.
  • Provide support to the Manufacturing staff as needed.
  • Other duties as assigned to meet the organization’s goals.
  • Demonstrates proficiency in job related skills.
  • Moderate involvement in audits, customer relations, and responsibility for inspection outcomes.
  • Has fiscal responsibility for areas of oversight.
  • Support a cohesive, high- performing team.
  • Limited responsibility for inspection outcomes

 

Knowledge, Skills and Abilities required:

  • Relevant four-year degree OR relevant Masters.
  • Two years relevant (w/4 YR degree) OR one years (w/Masters).
  • Experience in the manufacture of biologics or gene therapy required.
  • Experience in highly regulated field preferred. (cGMP/ GLP)
  • Able to maintain a positive work environment.
  • Ability to work with highly confidential materials.
  • Ability to work with some independence based on applicable experience.
  • Experience in technical writing.
  • High degree of attention to detail.
  • Mastery of Microsoft Office suite as well as other software.
  • Familiarity in USP, EP and ISO are critical.

 

Preferred Skills:

  • Experience in a highly regulated field.
  • Experience with statistical analyses.
  • Experience using bioreactors.

 

Minimum Physical Requirements

  • Sitting Constantly (67-100%)
  • Talking on the phone/in person Constantly (67-100%)
  • Typing on a computer keyboard Constantly (67-100%)
  • Standing/walking Occasionally (0-33%)                                                             

 

EOE M/F/Disability/Vet

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