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Development Scientists/Engineering Summer Intern (Undergraduate or Grad)

Employer
Andelyn Biosciences
Location
Columbus, OH
Start date
Feb 24, 2024

Job Details


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
  •  

    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 an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, genetic information, disability, status as a protected veteran, or other characteristics protected by federal or state law.


 




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.  

Company info
Website
Phone
614-580-8522
Location
1180 Arthur E. Adams Dr.
Columbus
OH
43221
United States

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