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.

The Data Specialist (LIMS) will be responsible for the day-to-day operations and setting up studies.  Overall account management, creation and revision, as well as review and approval of master data within the LabVantage Laboratory Information Management System (LIMS).  This position will be responsible for providing end-user support for all analytical groups as well as compliance to internal policies and procedures.

  • Creation/revision, review and approval of master data, including but not limited to products, specifications, test methods, parameters, and arrays per site procedures and specifications.
  • Creation/revision, review and approval of transactional data including but limited to batches, sample plans, consumable types, consumable lots, instruments, instrument models, array methods and stability protocols.
  • Assist in the development, implementation, enhancement of the overall process for requesting, creating/revising, and reviewing of master data.
  • Assist in the development, implementation, and maintenance of a site process for the scheduling and status tracking of all LIMS Master Data, including needs for Raw Material, Finished Goods, and Stability testing.
  • Development and/or revision of LabVantage Standard Operating Procedures & Work Instructions
  • Train end users on the system and proper functionality of the application.
  • First-line support for end-user questions and data entry issues.
  • Collaborate with Digital & Technology Solutions (DTS) team and project stakeholders to define needs and achievable solutions and/or justifications to system requirements.
  • Evaluation of system release notes with DTS to guide business on new enhancements, system fixes, process improvements to define system upgrade requirements.
  • Assist in the development, implementation, and interfacing of laboratory instruments with TetraScience SDMS and LabVantage.
  • Assist in the development and/or execution of validation documentation including but not limited to user requirements, functional specifications, unit tests, integration tests and regressions test scripts.
  • Assist with developing business reports with system data in LIMS and Andelyn’s Data Warehouse.
  • Perform analytical testing as necessary.
  • Assists laboratories with the management of laboratory investigations related to LIMS.
  • Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
  • All other duties as assigned.
  • Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed.

 

What you bring to the team.

  • Bachelor's degree program at an accredited university/college focusing on any of the following disciplines: Biology, Chemistry, Engineering, Information Technology, or related discipline.
  • Experience with working in LIMS systems
  • GMP experience required
  • Excellent communication, organization, and project management skills.
  • Superior attention to detail in all work products.
  • Dynamic, self-starter with strong interpersonal skills.
  • Ability to work independently and prioritize projects.
  • Ability to collaborate on a team towards accomplishing business goals.
  • Willingness to undertake assignments involving unfamiliar subjects.
  • Ability to complete complex tasks efficiently and react with appropriate urgency to situations that require a quick turnaround.
  • Demonstrate a high level of integrity.
  • Attention to detail in all job functions.
  • Skilled in Microsoft Office (PowerPoint, Excel, Word).

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.