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.
The Program Manager supports 5-10+ client programs, with up to 2 client programs in the cGMP clinical manufacturing phases at any given point in time. The ideal individual comes with biopharmaceutical and/or cell and gene therapy process development and analytical development understanding, working directly with/having familiarity with PD/AD agreements and contracts. This person is well versed in seamlessly integrate agreements, development programs, and clinical manufacturing client discussions with an eye towards commercial client program support. As the Program Manager, you are measured against objectives which include acting as the primary customer contact during the delivery phase of the project, leading and/or facilitating multifunctional teams, and ensuring the successful delivery of complex customer projects.
What you will do.
- Ensuring on time, on budget/on quality delivery of a portfolio of gene therapy programs, typically involving multiple platform technologies as well as customized solutions
- Acting as the main customer interface and customer advocate during project delivery
- Ensuring an excellent customer experience
- De-risking project timelines and deliverables using risk management methods
- Ensuring project execution is performed in compliance with existing procedures
- Utilize project management tools and processes
- Operate within the Quality Management System applicable to the manufacture of phase appropriate material in the facilities
- Maintain compliance with applicable regulatory requirements for cellular and gene therapy products
- Operates in alignment with established policies, procedures, and techniques, requiring relevant training, practical experience, or a working knowledge of the tasks involved.
- Anticipating problems and removing obstacles to enable staff to perform tasks as assigned
- Work to specific measurable objectives requiring operational planning skills with little direct supervision
- Cultivate a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of department goals
- Enforcing procedures and controls
- Moderate travel required
- Occasional involvement in audits
- Consistent involvement in customer relations
- Have significant latitude for making decisions for their operational or functional unit
- Drives timelines and development through the broad influence
- Minimal interaction with legal services
- Other duties as assigned
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
- Four years relevant experience (w/4 YR deg) OR two years experience with relevant graduate degree or certification
- Experience in biologics or gene therapy preferred OR extensive experience in a highly regulated 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) 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
- Demonstrate a high level of integrity
- Maintain a positive attitude
- Attention to detail in all job functions
- Exercise discretion, judgment, and personal responsibility
- Exercise crucial people skills
- Ability to manage and influence people in lateral support structure
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 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.