Overview of Andelyn Biosciences

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that specializes in advancing novel gene therapies from concept to commercialization.  Located in Columbus, OH, the company operates out of the Andelyn Corporate Center (ACC) for clinical and commercial cGMP manufacturing of viral vectors and plasmids and the Andelyn Development Center (ADC) for preclinical non-cGMP activities.

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.

Specialist II will complete the principal duties and responsibilities outlined below. Working in collaboration with leadership and senior staff, Specialist II will participate in the implementation and execution of critical cleanroom sterility assurance strategies. Activities may include the performance of routine environmental monitoring (EM), supporting EM data entry / review / reporting, coordination of project timelines / tasks, authoring / reviewing technical and procedural documents, as well training and mentoring junior staff. Specialist II will support efforts to deliver all products in a timely, compliant, and fiscally responsible fashion.

  • Execute routine environmental conditions / environmental monitoring sampling.
  • Review documentation for completion and accuracy, file documentation for timely retrieval.
  • Prepare data summaries for quarterly environmental conditions trending reporting – scope may include but is not limited to, microbial environmental monitoring, non-viable particle monitoring, temperature, and differential pressure.
  • Identifies adverse environmental conditions / environmental monitoring trends.
  • Provides support for cross-functional quality event investigations related to environmental conditions / environmental monitoring.
  • Assist the Quality Assurance department with product disposition by providing any necessary data summaries.
  • Author/revise/review GxP documentation related to environmental conditions / environmental monitoring and associated reporting and trending practices – documentation may include but is not limited to, standard operating procedures, work instructions, technical protocols, and technical reports.
  • 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 manufacturing operations.
  • Maintain compliance with applicable regulatory requirements for cellular and gene therapy products • Attention to detail in all job functions.
  • Operates in alignment with established policies, procedures, and techniques, requiring relevant training, practical experience, or a working knowledge of the tasks involved.
  • 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 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 audits.
  • Limited involvement in customer relations
  • Limited responsibility for inspection outcomes.
  • Weekend availability as needed.
  • Other duties as assigned.

 

What you bring to the team.

  • Must possess relevant four-year degree OR relevant master’s OR relevant Ph.D., background in the life sciences, biotechnology, or gene therapy industries preferred.
  • Three years relevant (w/4 YR deg) OR no experience with (w/Masters).
  • Strong understanding of GxP is required.
  • Experience with microbiology and/or monitoring cleanroom environmental conditions is preferred.
  • Experience in biologics or gene therapy preferred.
  • 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 that have over 10 years in the gene therapy field.
  • Competitive compensation
  • Eligible 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 Paid Holidays plus 2 floating holidays annually.
  • Company-paid 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.