GMP Plasmids Scientist II

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.

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.

Scientist II will be responsible for adhering to policies, protocols, and SOPs and following appropriate documentation procedures for GMP manufacturing. Secondary responsibilities include peer review of Production documentation, assisting with laboratory investigations, SOP generation or revision, training of junior staff, and other tasks needed to support the primary responsibilities.

• Provide leadership in daily operational activities related to the GMP manufacturing of biological products, ensuring efficient execution of production processes while maintaining compliance with regulatory standards.
• Mentor, train, and supervise junior staff to ensure proper operation of facility equipment and adherence to accurate documentation of activities and product quality.
• Work closely with GMP Management to drive continuous improvement and innovation.
• 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.
• Ensure the availability of materials and oversee proper documentation surrounding GMP activities and product quality.
• Write, review, and maintain Standard Operating Procedures (SOPs) related to equipment, processes, and laboratory operations, ensuring compliance with regulatory guidance.
• Operate and perform calibration, validation, cleaning, and maintenance of facility equipment and systems as specified in SOPs.
• Identify problems, assist in troubleshooting, and present solutions to address issues efficiently.
• Respond to and act on alarm notifications from applicable monitoring systems for laboratory temperature-controlled storage units during assigned periods of responsibility.
• Manage and review the compilation of all data, ensuring accuracy and completeness.
• Work in a diverse and collaborative team environment, utilizing clear communication to maintain high productivity.
• Contribute to the success of team goals by ensuring adherence to best practices and regulatory standards in GMP manufacturing.
• Works in a diverse and collaborative team environment utilizing clear communication to deliver high productivity and contributes to the success of team and goals
• Ability to work with some independence based on applicable experience
• Exercise discretion, judgment, and personal responsibility
• Demonstrate a high level of integrity
• Maintain a positive attitude
• Attention to detail in all job functions
• Make decisions based on established procedures
• Documentation of all activities performed according to SOPs
• Limited involvement in audits and customer relations
• Other duties as assigned

• Must possess a relevant four-year degree OR relevant master’s OR relevant Ph.D., background in the life sciences, biotechnology, or gene therapy industries preferred
• Three years relevant (w/4 YR deg) OR 2 years relevant experience with (w/Masters)
• Knowledge and experience in aseptic technique, fermentation, cell culture, Chromatography, TFF, liquid separation techniques, and/or fluid handling
• Experience in biologics or gene therapy (plasmid manufacturing 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 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
• Attention to detail in all job functions
• Infrequent travel required

• 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)

As an organization, we are committed to creating an environment where everyone ACCTS.