Scientist II - Manufacturing, Science, and Technology - Andelyn Biosciences, Inc

Overview of Andelyn Biosciences

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization. Located in the heart of Columbus, OH, the company has expanded to three buildings with more than 250,000 combined square feet of space.  The Andelyn Corporate Center (ACC) is dedicated to cGMP manufacturing, the Andelyn Development Center (ADC) for preclinical non-cGMP activities, and the Andelyn Plasmid Center (APC) for research and cGMP plasmid production.

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.

Scientist II will support tech transfer activities for plasmids, Gene Therapy Drug Substance (DS), and Drug Product (DP) manufacturing processes.  Scientist II will support upstream and downstream process development activities, including bioprocessing and analytics responsibilities. Working in close collaboration with Process Development, Manufacturing, and Supply Chain.  The Scientist II will support the execution of Engineering runs, Writing of Risk assessments, and Writing of Batch Records. Design of single-use assemblies and create recipes for bioreactor and chromatography systems. Also, supports process qualification and process improvement activities.

• Supports tech transfer activities for plasmids, and Gene Therapy Drug Substance (DS), and Drug Product (DP) manufacturing processes.
• Supports upstream and downstream process development activities, including bioprocessing and analytics responsibilities. Working in close collaboration with Process Development, Manufacturing, and Supply Chain.
• Supports the execution of Engineering runs, Writing of Risk assessments, and Writing of Batch Records. Design single-use assemblies and create recipes for bioreactor and chromatography systems. Also, supports process qualification and process improvement activities.
  • Process monitoring and general troubleshooting
• Post-Manufacturing Phase:
  • Close-out investigations and data analysis for on-time product release
• Performs Root Cause Analysis, writes change control justification, and drives continuous improvement and process improvement opportunities. 
• Exercise discretion, judgment, and personal responsibility
• Demonstrate a high level of integrity
• Maintain a positive attitude
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
• Attention to detail in all job functions
• Solving, correcting, and preventing problems and performing tasks as assigned by leadership, as well as assigning tasks to junior staff
• Works on specific measurable objectives requiring operational planning skills 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 the team and goals
• Documentation of all activities performed according to procedures
• Make decisions based on established procedures
• Infrequent travel required
• Moderate involvement in audits
• Moderate involvement in customer relations
• Other duties as assigned

What you bring to the team.

• B.S. Degree in Chemical / Biochemical / Biomedical Engineering, Biological Sciences, Molecular Biology, Virology, or other relevant major with 3+ years of progressive related industry experience. 
• Experience in biologics or gene therapy is preferred
• Experience in mammalian cell culture is preferred
• Experience in chromatography types: affinity, ion exchange, hydrophobic interaction, and multi-modal
• preferred
• Experience in Purification: depth filtration, tangential flow filtration, empty/full separation, chromatography, sterile filtration, and final fill of product.
• Prior experience in viral vector space is desirable
• Ability to communicate clearly with diverse groups of team members
• Ability to drive sound decision-making
• Ability to drive the project forward with collaboration
• Ability to manage projects using project management tools
• Experience in technical investigations
• Ability to analyze and resolve technical issues
• Analyzing, interpreting, and compiling data, logical conclusions, recommendations & decision making
• Naturally interested in strong documentation practices and detail-oriented
• Familiarity with software packages like: Visio®, JMP®, and MS Project®
• Experience in biologics or gene therapy is required
• 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 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.
• Four 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.