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 I – Process Development.

The Scientist I position will support upstream and downstream process development and responsibilities in bioprocessing and analytics. The Scientist I will provide hands-on assistance for day-to-day process development production operations, including execution and development of production and purification processes, development of in-process assays for physical and functional characterization of the product, documentation, and participate in scientific discussions.

Schedule: Full-time (Benefits Eligible)  

Location:  Andelyn Development Center

                  5185 Blazer Pkwy

                  Dublin, OH 43017 


*Multiple positions available* 


Under the guidance and direction of the Associate Director – Process Development essential functions of the Scientist I – Process Development include:

  • Respond to, and take action from, alarm notifications from the applicable monitoring system(s) for laboratory temperature-controlled storage units that occur at any point during the assigned period of responsibility
  • Develop sufficient knowledge and technical expertise for the production and purification of gene therapy vectors (e.g., AAV and lentivirus) 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 technical skills in Viral 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 used for in-process characterization: e.g., 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.
  • Exercise discretion, judgment, and personal responsibility
  • Demonstrate a high level of integrity
  • Maintain a positive attitude
  • 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
  • Performs following established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed
  • Identifies problems and performs tasks as assigned
  • Work under the general supervision of senior staff and leadership
  • Works in a diverse and collaborative team environment utilizing clear communication to deliver high productivity and contributes to the success of team and goals
  • Documentation of all activities performed according to SOPs
  • Make decisions based on established procedures
  • Nominal fiscal responsibility
  • Other duties as assigned

 

 

Knowledge, Skills and Abilities required: 

  • Must possess a relevant four-year degree, background in the life sciences, biotechnology, or gene therapy industries preferred
  • No minimum experience
  • Experience in highly regulated field preferred
  • Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change
  • Must be literate in Microsoft Office (PowerPoint, Excel, Word)
  • Ability to work independently as well as collaboratively in a diverse and inclusive work environment.
  • Must possess a client-focused mindset in daily tasks
  • Must possess prior experience handling confidential information and the ability to maintain confidentiality

 

Minimum Physical Requirements

  • Frequently Sitting
  • Frequently Walking/Standing/Stooping
  • Occasionally Independently lifting up to 50 pounds
  • Frequently Talking on the phone or in-person
  • Frequently Typing on a computer keyboard

 

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.    

 

Andelyn Biosciences is committed to a diverse and inclusive workplace. Andelyn is an equal opportunity employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or another legally protected status.
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