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 Turning 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 bring to the team.

The Quality Control (QC) Specialist II – Documentation is an individual contributor role and provides compliance and quality improvement support to the Andelyn Quality Control (QC) department. This role will work in conjunction with QC Management to conduct data review as well as administrative tasks to support the quality management program and to assure that QC is compliant with applicable regulations, policies, and procedures. The QC Specialist II - Documentation will support a variety of quality improvement and process improvement initiatives.

  • Operate within the Quality Management System applicable to the manufacture of phase appropriate material in the CMF.
  • Works in close collaboration with QC Supervisor/Manager and senior QC staff to cultivate and enact strategic direction of the Quality Control department.
  • Review Quality Control data in support of release, stability, and client specific projects.
  • Provide day-to-day support to QC team to ensure analytical data review timelines are met.
  • Represent the QC group in continuous improvement committees or working groups. Incorporate process improvement tools to guide working groups.
  • Review and compare relevant documents and manufacturer’s CoA for suitability in order to release raw materials for use in manufacturing operations.
  • Assist with and provide QC support for changing controls and other related controlled documents in the eQMS.
  • Review of Quality Systems data for trends within assigned areas of support and report to Functional Area Management, QA and provides quality improvement training for staff as needed.
  • Perform QC functions including but not limited to product release data review, starting material data review and release, and stability report generation and data review.
  • Routinely identifies quality issues and reports to senior QC staff and management.
  • Assist with the material release process by assuring suitability of production materials.
  • Assist QC Management with identifying areas for quality improvement. Work with senior QC staff and management to develop action plans and metrics needed to monitor progress toward meeting quality improvement objectives.
  • Assist with investigations, deviations, CAPA, validation documents, change control and other related documents for the Quality Control laboratory.
  • SME for QC processes and procedures. Mentor junior QC staff as needed.
  • Provide support for audits.
  • Ability to work with some independence based on applicable experience.
  • Exercise discretion, judgment, and personal responsibility.
  • Demonstrate high levels of integrity in all aspects of the position.
  • Maintain positive attitude.
  • 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.
  • Solving, correcting, preventing problems and perform tasks as assigned by leadership, as well as assigning tasks to junior staff.
  • Work to specific measurable objectives requiring operational planning skill with little direct supervision.
  • Leads and supports a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of team and goals.
  • Documentation of all activities performed according to SOPs.
  • Make decisions based on established procedures.
  • Nominal fiscal responsibility.
  • Infrequent travel required.
  • Minimum involvement in audits.
  • Minimum involvement in customer relations.
  • Minimum responsibility for inspection outcomes.
  • Mentoring of junior staff.
  • Other duties as assigned.

 

What you bring to the team.

 

  • Must possess a relevant four-year degree OR relevant master’s OR relevant PhD
  • Three years relevant (w/4 YR deg) OR two years (w/Masters)
  • Experience in biologics or gene therapy required
  • Experience in a highly regulated field is preferred. Knowledge of regulatory (FDA) requirements and understanding of aseptic processes preferred.
  • Excellent communication, organization, and project management skills with the ability to manage multiple projects 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
  • 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 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.