It’s an exciting time to join us!

The Andelyn Biosciences’ Process Development group is seeking a motivated individual to join our growing team as a Scientist II – Process Development.

The Scientist II position will support upstream and downstream process development and responsibilities in bioprocessing and analytics. The Scientist II will participate in discussions on process qualification, development of production methods and analytical assays for evaluation of in-process and final product, as well as the evaluation of run-to-run variability. 


Schedule: Full-time (Benefits Eligible)  

Location:  Central Campus 

                  575 Children's Crossroads

                  Columbus, OH 43205 


Under the guidance and direction of the Associate Director – Process Development essential functions of the Scientist II – Process Development include at a minimum:

  • Rapidly develop sufficient expertise to function independently with minimal supervision. Research and development for the production and purification of multiple serotypes of Adeno Associated Virus (AAV).
  • Production of AAV using adherent and suspension platforms using stacks, shaking flasks, and bioreactors with specific knowledge of process related and product related impurities.
  • Growth of cells lines and isolation of mammalian cells; aseptic technique.
  • AMBR and Single Use Bioreactor bioprocessing.
  • AAV Purification: depth filtration, tangential flow filtration, empty/full separation, chromatography, sterile filtration, and final fill of product.
  • Chromatography types: affinity, ion exchange, hydrophobic interaction, and multi-modal.
  • Optimizing processes / process qualification for Phase 3; determination of CPPs and CQAs using in process data.
  • Single use equipment/consumables for large scale purification.
  • Analytics: Experience with analysis of qPCR, ddPCR, DLS, HPLC, and related analyses.
  • Statistical analysis software such as GraphPad Prism, MATLAB.
  • cGMP Cleanroom experience.
  • Documentation Experience: Completion of GMP tech transfer and authoring Standard Operating Procedures, Technical Reports, Phase III documentation, Risk Assessments, and Equipment Validations.


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.
  • Identify problems and propose solutions.  Performs tasks as assigned by leadership.
  • Ability to work with some independence based on applicable experience.
  • 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: 

  • Four years relevant experience with Chemistry, Biochemistry, or similar 4-YR degree.  Alternatively, no experience with relevant graduate degree. 
  • Experience in highly regulated field preferred
  • Effective communication and interpersonal skills required.
  • Experience of with AAV production using single use bioreactors, cleanroom procedures, tech transfer, aseptic technique, method development of analytics required.
  • Experience with statistical analyses strongly 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 so classified, 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.


EOE M/F/Disability/Vet


Andelyn Biosciences is currently operating under Executive Order 14042 that 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 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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