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.

The Specialist II – Quality Assurance (Operations) role supports the Andelyn Plasmids Center Manufacturing Facility by providing Quality Assurance oversight of manufacturing processes. This position will be responsible for ensuring compliance with current Good Manufacturing Practices (cGMP) regulations, policies, and procedures applicable to the Operations department.  The Specialist II – Quality Assurance (Operations) reports to the GMP Supervisor of Quality Assurance.

.

  • Maintain compliance with applicable regulatory requirements for gene therapy products.
  • Operates within the Quality Management System applicable to the manufacture of phase appropriate materials in the Manufacturing Facility
  • Provides day-to-day support, including QA on-the-floor oversight, to the Operations team so production timelines are met.
  • Serves as QA support for cross-functional projects supporting manufacturing activities at the Andelyn Corporate Center (ACC)
  • Supports AAV and Diluent product releases to meet target disposition dates.  
  • Reviews and approves master and executed batch record documents.
  • Conducts approval of pre-start-up activities including line/room clearance and initial equipment checks
  • Ensures that documentation is maintained following internal procedures and regulatory requirements.
  • Supports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departments.
  • Discusses errors directly with ACC Operations personnel so corrections can be made if required.
  • Reviews production logbooks for accuracy and compliance
  • Assists the GMP Supervisor in identifying and supporting areas for continuous quality improvement and the development of action plans and metrics needed to monitor progress toward meeting quality improvement objectives.
  • Supports GMP product releases from the manufacturing facility by providing review of required documents as needed.
  • Provides additional support as directed by Quality Assurance Management
  • Works with Plasmids Operations to address client comments and/or questions related to batch records.
  • Exercise discretion, judgment, and personal responsibility.
  • Demonstrates a high level of integrity.
  • Maintains a positive attitude.
  • Attention to detail in all job functions is required.
  • Documentation of all activities performed according to SOPs.
  • Makes decisions based on established procedures.
  • Infrequent travel may be required.
  • Other duties as assigned.

 

What you bring to the team.

  • Must possess Bachelor of Science degree, background in the life sciences, biotechnology or gene therapy industries preferred.
  • Minimum of two (3) years’ experience (w/4 YR degree) in a regulated field OR no experience (w/Masters)
  • Knowledge of aseptic processes in a cleanroom environment is preferred.
  • Excellent communication, organization, and project management skills with the ability to manage multiple tasks efficiently and adjust as priorities change.
  • Must be highly 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.
  • Attention to detail and ability to execute multiple tasks successfully.
  • 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 in contributing to the development and manufacturing of lifesaving therapies.
  • The invaluable experience of being a part of building the foundation of a new organization.
  • The opportunity to collaborate with 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.

 

 

This position has been filled. Would you like to see our other open positions?