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 primary responsibility for the Metrology Specialist II is the application of measurement science, mathematics, and electronics for calibration inspection, measurement, and test equipment of various cGMP/non GMP disciplines ensuring measurement functional accuracy. Identify and utilize appropriate measurement, preventative maintenance activities for critical manufacturing processes. Adapt equipment, standards/procedures to accomplish critical measurements and preventative maintenance deliverables. Performing corrective actions to address identified measurement and reliability problems, including activities developing writing/reviewing documents in support of the change control process. Additional responsibilities include managing the receipt/shipment of equipment, managing outsource calibration by vendors, preparing/reviewing deviation documentation, providing support during audits, and other tasks as needed to support department and business functions.

 

  • Preserve equipment readiness so that customer needs relating to the conduct of testing are met in a suitable manner
  • Maintain equipment within established parameters governing regulatory compliance expectations
  • Make certain all equipment is entered, scheduled, and maintained in the appropriate CMMS system
  • Ensure all equipment documentation is complete, up-to-date, and stored properly
  • Maintain and update calibration data as required
  • Evaluate calibration/qualification records supplied by third party vendors
  • Document all findings in compliance with cGMP standards
  • Coordinate outside calibration testing for equipment as needed
  • Assume lead role in Out of Tolerance Investigations when necessary
  • Participate in department and/or company-wide medium projects designed to improve the nature of customer service
  • Participate in customer audits as directed by Quality Management
  • Authors and reviews department SOP’s, risk assessments, and equipment calibration protocols
  • Communicates with equipment users for procedure updates
  • Cultivates a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of department goals
  • Mentors’ equipment users on new equipment
  • Ability to work through GMP processes for equipment failures
  • Exercises crucial people skills
  • Exercise discretion, judgment, and personal responsibility
  • Demonstrate high level of integrity
  • Maintain 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 in accordance with 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 general supervision of senior staff and leadership
  • Works in 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

 

 

What you bring to the team.

  • BA/BS in a scientific field plus 2 years’ job experience. In lieu of degree, four years relevant laboratory, cleanroom, and or manufacturing experience in a regulated environment and dealing with general and biological process equipment required.
  • Thorough knowledge of scientific principles required (general SOPs, GMP/GLP and ISO regulations).
  • 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.

 

 

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.