Quality Assurance Summer Intern, Supplier Quality

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.

This position will be responsible for supporting the Supplier Quality Management program at Andelyn Biosciences. This role involves collaborating with internal teams and suppliers to ensure that all products and services meet quality standards, regulatory requirements, and contractual obligations. The Specialist will assist in the development, implementation, and continuous improvement (as needed) of the supplier qualification, evaluation, and performance monitoring processes to maintain a high level of quality and compliance in the supply chain.

• Support the qualifications of new and existing suppliers for clinical and commercial manufacturing.
• Assist in conducting supplier audits, assessments, and site inspections to ensure adherence to GMP, quality standards, and regulatory requirements.
• Coordinate corrective and preventive actions (CAPAs) following audit findings.
• Track and evaluate supplier performance, including on-time delivery, quality metrics, and non-conformance rates.
• Work closely with suppliers to resolve quality-related issues and implement continuous improvement initiatives.
• Identify and assess risks associated with suppliers and supply chain operations.
• Support the development and implementation of risk mitigation strategies in collaboration with internal stakeholders.
• Maintain accurate records of supplier audits, assessments, and performance data.
• Ensure that all supplier documentation is up to date and in compliance with GMP, regulatory standards, and internal procedures.
• Collaborate with sourcing, procurement, quality control, manufacturing, and regulatory teams to ensure the seamless integration of supplier quality requirements.
• Provide support for the resolution of quality issues that may arise during production or in the supply chain.
• Other duties as assigned.

What you bring to the team.

• Seeking a Bachelor’s degree in Life Sciences, Engineering, or related field.
• 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)
• 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 the ability to handle 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.

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.