Overview of Andelyn Biosciences

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization. Located in the heart of Columbus, OH, the company has expanded to three buildings with more than 250,000 combined square feet of space.  The Andelyn Corporate Center (ACC) is dedicated to cGMP manufacturing, the Andelyn Development Center (ADC) for preclinical non-cGMP activities, and the Andelyn Plasmid Center (APC) for research and cGMP plasmid production.

Our Values are founded in our origin story.

The name “Andelyn” is a hybrid of two gene therapy patients 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 to represent all the families who have courageously participated in the research that makes today’s gene therapies possible. 

 

Through this journey, we have been able to accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. We are Pioneering Solutions that Turn Hope into Reality™ through our ACCTSions.

 

ACCOUNTABLE in our actions.

CURIOUS to discover.

COMPASSIONATE in our thinking.         

TRUSTWORTHY in our communications.

SUPPORTIVE of one another.

 

Employees are expected to perform the following essential functions under the framework of our ACCTSions.

 

What you will do.

A Scientist II, in Process Devlopment, will support upstream and downstream process development activities including responsibilities in bioprocessing and analytics. Working in close collaboration with PD leadership and PD scientists, scientist II will support the execution and completion of projects involving platform development, optimization, in-process characterization, and tech transfer following appropriate regulatory practices, timelines, documentation, and standard operating procedures. Prior experience in the purification of biologics is preferred. He/She will keep abreast with state-of-the-art technologies and scientific advancements in the field and participate in discussions on scale-up of processes, process qualification, and strategies for process improvement.

  • Rapidly develop sufficient expertise to function independently with minimal supervision
  • Participate in research and development for the production and purification of gene therapy vectors.
  • Participate in the production of gene therapy vectors using adherent and/or suspension platforms utilizing stacks, shaking flasks, and/or bioreactors with specific knowledge of process-related and product-related impurities.
  • Develop expertise in the growth of cell lines and isolation of mammalian cells, aseptic technique.
  • Facilitate and support optimization of processes/process qualification for Phase 3; determination of CPPs and CQAs using in-process data.
  • Support completion of GMP tech transfer and author Standard Operating Procedures, Technical Reports, Phase III documentation, Risk Assessments, and Equipment Validations.
  • Participate in experimental design, planning, and execution.
  • Participate in a team environment, including fostering a culture of collaboration
  • Support development activities in other departments in the organization to resolve issues related to product manufacturing, testing, and performance
  • Exercise discretion, judgment, and personal responsibility
  • Demonstrate a high level of integrity
  • Maintain a positive attitude
  • Maintain compliance with applicable regulatory requirements for cellular and gene therapy products
  • Attention to detail in all job functions
  • Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed
  • Identifies problems and proposes solutions.  Performs tasks as assigned by leadership
  • Ability to work with some independence based on applicable experience
  • Works in a diverse and collaborative team environment utilizing clear communication to deliver high productivity and contributes to the success of the team and goals
  • Documentation of all activities performed according to SOPs
  • Make decisions based on established procedures
  • Nominal fiscal responsibility
  • May require some travel
  • Limited involvement in customer relations
  • Other duties as assigned

 

 

What you bring to the team.

  • Must possess relevant four-year degree OR relevant master’s OR relevant PhD; background in the life sciences, biotechnology or gene therapy industries preferred
  • Three years relevant (w/4 YR deg) OR no experience with (w/Masters)
  • Experience in biologics or gene therapy preferred
  • Experience in mammalian cell culture preferred
  • Experience in chromatography types: affinity, ion exchange, hydrophobic interaction, and multi-modal preferred
  • Experience in Purification: depth filtration, tangential flow filtration, empty/full separation, chromatography, sterile filtration, and final fill of product.
  • 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 skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting
  • 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

 

What you can expect when working at Andelyn.

  • The pride of contributing to the development and manufacturing of life-saving therapies.
  • The invaluable experience of being a part of building the foundation of a new organization.
  • The opportunity to work alongside experts who have over 10 years in the gene therapy field.
  • Competitive compensation
  • Eligible on day one for medical, dental, and vision insurance plans with basic vision at 100% company-paid
  • 160 hours of Paid Time Off annually
  • 11 Company Paid Holidays plus 2 floating holidays annually.
  • Company Paid Life Insurance
  • 401(k) Match
  • Company Paid short and long-term disability.
  • 4 weeks of Paid Parental Leave for birth and adoption
  • Adoption Assistance
  • Tuition Reimbursement and Student Loan Repayment Assistance
  • Company Paid LinkedIn Learning access.
  • Employee Assistance Programs
  • Flexible work options (role specific)

 

Andelyn Biosciences embraces diversity and is an equal opportunity employer and does not discriminate based on race, religion, national origin, gender, gender identity, genetic information, sexual orientation, protected veteran status, disability, age, or another legally protected status. As an organization, we are committed to creating an environment where everyone ACCTS.