It’s an exciting time to join us!

The Andelyn Biosciences MS&T department is seeking two motivated college students to join us who have either scientific or engineering backgrounds. The interns will learn how pharmaceutical manufacturing facilities operate. You will be supporting engineers and scientists as we prepare for our new facilities.  

Under the guidance and direction of the Head of MS&T essential functions of the Undergraduate Summer Interns include:

• • Develop sufficient knowledge and technical expertise for the production and purification of multiple serotypes of Adeno Associated Virus (AAV) using adherent and suspension platforms using stacks, shaking flasks, and bioreactors.
  • Develop specific knowledge of process-related and product-related impurities.
  • Develop expertise in aseptic technique and growth of cells lines.
  • Develop knowledge of AMBR and Single-Use Bioreactor bioprocessing.
  • Develop technical skills in AAV Purification: depth filtration, tangential flow filtration, chromatography, sterile filtration, and final fill of product.
  • Understand scale up using single-use equipment/consumables for large-scale production and purification.
  • Understand Analytics: qPCR, ddPCR, DLS, HPLC, and related physical and functional analyses.
  • Acquire cGMP cleanroom experience.
  • Develop expertise in the documentation: Completion of GMP tech transfer and authoring Standard Operating Procedures, Technical Reports, Phase III documentation, Risk Assessments, and Equipment Validations.
  • Support equipment validation activities

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  General Responsibilities:

  • 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.
  • Attention to detail in all job functions.
  • Perform in accordance with established policies, procedures, and techniques.
  • Performs tasks as assigned by leadership.
  • Work collaboratively in a diverse team.  Maintain positive relationships, utilize clear communication, and operate with a high level of integrity to deliver high productivity and success in the team and PD goals.
  • Documentation of all activities performed according to SOPs.
  • Make decisions based on established procedures.
  • Exercise discretion, judgment, and personal responsibility.
  • Has nominal fiscal responsibility.
  • May require limited travel, limited involvement in client-related projects, limited involvement in audits, and limited involvement in inspection outcomes.

   

   

  Knowledge, Skills, and Abilities required: 

  • Sophomore college standing and above
  • Chemistry and other scientific related coursework
  • Effective communication and interpersonal skills are required.
  • Experience with scale-up preferred.
  • Experience with AAV or related production, tech transfer, aseptic technique, method development preferred.
  • Experience with statistical analyses is preferred.
  • Skills in operating a personal computer.  Must be familiar with various software packages (e.g., Word, Excel, PowerPoint, Prism Graph-Pad, MATLAB). Knowledge of programming software a plus.

   

  Minimum Physical Requirements

  • Sitting for extended periods occasionally (67-100%).
  • Talking on the phone/in person.
  • Typing on a computer.
  • Standing/walking (0-33% of the time).        

   

  
  

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, 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 which 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 the first date of employment.  Religious and medical exemptions may be considered depending upon the specific job duties and in accordance with applicable federal guidelines.

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