GMP Scientist - Plasmids

Andelyn Biosciences, Inc; Columbus (OH); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Competitive compensation

Eligible medical, dental and vision on

401(k) match

Company paid short and long-term dis‑

Job summary

Andelyn Biosciences is seeking a Scientist I to provide hands-on support for day-to-day plasmid production operations in Columbus, OH. You will follow SOPs, document activities, and help maintain batch records to ensure compliant manufacturing of plasmids for research and early-stage programs.

You will collaborate with a diverse team, prepare critical solutions, and assist in troubleshooting and process improvements while maintaining high accuracy and regulatory alignment.

Qualifications

• Bachelor's degree in life sciences or biotechnology, preferred for this role.
• Experience in highly regulated environments is a plus.
• Excellent communication, organization, and project management skills.

Responsibilities

• Support day-to-day plasmid production operations following SOPs.
• Document activities and maintain batch records for compliance.
• Prepare and inventory solutions used in plasmid production.
• Troubleshoot issues and work with management on process improvements.

Skills

Communication

Project management

Organization

Team collaboration

Confidentiality

Education

Bachelor's degree in life sciences

Tools

Microsoft Office

Job description

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that specializes in advancing novel gene therapies from concept to commercialization.Located inColumbus, 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 therapypatientswho 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.

COMPASSIONATE in our thinking.

RUSTWORTHY in our communications.

SUPPORTIVE of one another.

Employees are expected to perform the following essential functions under the framework of ourACCTSions.

What you will do.

The primary responsibility is to provide hands-on assistance for all day-to-day plasmid production operations, including the execution of production processes, documentation, as well as preparation and inventory maintenance of solutions prepared in-house for use in plasmid production processes. This role will support production efforts to deliver all products in a timely, compliant, and fiscally responsible fashion by following appropriate practices, batch records, and Standard Operating Procedures (SOPs) for manufacturing biological products. The Scientist I will work with other Plasmid Production staff to expand the knowledge base and skill set. Additionally, the Scientist I, will learn to troubleshoot issues as well as trend errors and work with management to identify areas for process improvement.

• Respond to, and take action from, alarm notifications from the applicable monitoring system(s) for laboratory temperature-controlled storage units that occur at any point during the assigned period of responsibility.
• Responsible for assisting in the support of the production of plasmids used for basic research and toxicology studies.
• Coordinating and preparation of critical solutions used in the production of plasmids for research studies,
• Ability to work with some independence based on applicable experience.
• Functional working in a diverse and collaborative team environment utilizing clear communication to deliver high productivity.
• Exercise discretion, judgment, and personal responsibility.
• Demonstrate a high level of integrity.
• Operate within the Quality Management System applicable to the manufacture of phase appropriate material.
• 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.
• Identifies problems and performs tasks as assigned.
• Work under the general supervision of senior staff and leadership.
• Works in a 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.

• Must possess a relevant four-year degree, background in the life sciences, biotechnology, or gene therapy industries preferred.
• 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 employerand 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 everyoneACCTS.