GMP Scientist II

Andelyn Biosciences, Inc.; Columbus (OH); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Paid Time Off

Holidays

401(k) Match

Parental Leave

Tuition Reimbursement

Student Loan Assistance

Life Insurance

Disability Insurance

Flexible work options

Job summary

Andelyn Biosciences in Columbus, OH seeks a Scientist II Production to learn and oversee AAV vector production, ensuring cGMP compliance and leading a production team. You will coordinate materials, documentation, and SOP updates while guiding junior staff and maintaining a safe, compliant environment.

The role requires a life sciences degree (PhD/Master’s preferred) and experience in regulated bioprocessing; strong communication and project management are essential for success in this

Qualifications

• Excellent communication, organization, and project management skills.
• Must possess a four-year degree or higher in life sciences (or related field).
• Experience in biologics or gene therapy preferred; highly regulated environment experience a plus.

Responsibilities

• Learn all aspects of adeno associated viral (AAV) vector production and lead/coordinate execution.
• Oversee GMP manufacturing of biological products and ensure material availability and proper documentation.
• Train junior staff and provide guidance to production teams.
• Draft and revise SOPs; maintain ALCOA documentation and clean, safe work environment.
• Ensure compliance with regulatory requirements for cell and gene therapy products.

Skills

Project management

Communication

Organization

Team collaboration

Data interpretation

Education

Four-year degree / Master’s / PhD in life sciences

Tools

Microsoft Office

Job description

Andelyn Biosciencesis 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 thedevelopmentand manufacturing of innovative therapies to bring more treatments to more patients. We are Pioneering Solutions that Turn Hope into Reality™ through ourACCTSions.

ACCOUNTABLEin our actions.

COMPASSIONATEin our thinking.

TRUSTWORTHYin our communications.

SUPPORTIVEof one another.

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

What you will do.

The Scientist II Production role will learn all aspects of the adeno associated viral (AAV) vector production. They will master procedures and be able to lead and coordinate their execution. The Scientist II will be responsible for adhering to cGMP principles while overseeing production teams in the production of AAV drug substances. They will work with Management and Senior Staff to plan and execute operations goals.

• Responsible for assisting and leading operations in the support of the production of viral vectors used in clinical trials
• Responsible for leading and performing daily operational activities related to the GMP manufacturing of biological products, by executing production processes including assuring the availability of materials and the proper documentation surrounding GMP activities and product quality.
• Contribute to material inventory tracking
• Learn all areas of operation involved in production activities
• Provide training to staff
• Anticipate, solve, correct, and prevent problems including error trending and CAPA implementation
• Solving, correcting, preventing problems, and performing tasks as assigned by leadership, as well as assigning tasks to junior staff
• Draft and revise SOPs and controlled documents
• Uphold a clean and safe work environment
• Understanding of Industry guidelines for drug product fill is required
• Working knowledge of various aseptic filling methods, including automatic and manual is essential
• 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
• Oversee and train junior staff in GMP operations in a regulated work environment.
• 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 in the CMF
• 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 proposes solutions. Perform tasks as assigned by leadership
• Ability to work with some independence based on applicable experience
• 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
• Adhere to good documentation principles and ALCOA in the support of all production activities
• Make decisions based on established procedures
• Nominal fiscal responsibility
• May require some travel
• Limited involvement in audits
• Limited involvement in customer relations
• Limited responsibility for inspection outcome

What you bring to the team.

• Must possess 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 no experience with (w/Masters)
• Experience in biologics or gene therapy 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 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 on 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 Biosciencesembraces 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.