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.
The primary responsibility for the Project Manager Quality Control is the management and coordination of client needs relating to quality control testing. This includes developing testing protocols, defining project timelines, writing/reviewing documents, and collaboration with external clients and vendors. The Project Manager will work within Quality Control to ensure appropriate resources are available to support the projects to meet deadlines. Project management will require sufficient scientific experience to appreciate testing timelines as well as the capacity of available scientists.
- Operate within the Quality Management System applicable to the manufacture of cGMP material.
- Maintain compliance with applicable regulatory requirements for cellular and gene therapy products
- Assist the QC dept. in the organization, maintenance, and control of the Quality Management System
- Ensure products meet customer expectations and align with company objectives
- Performs following established policies, procedures, and techniques and requires training, common experience, or working knowledge related to the tasks performed
- 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
- Approval of procedures established by junior staff
- Has budgetary responsibility
- Frequent involvement in customer relations
- Significant responsibility for inspection outcomes
- Communicate the results of audits/inspections and put forward corrective actions
- Support mentoring and professional development of staff
- Exercise crucial people skills
- Demonstrate a high level of integrity
- Maintain a positive attitude
- Exercise discretion, judgment, and personal responsibility
- Ability to influence people in the direct and lateral support structure
- Attention to detail in all job functions
- Have significant latitude for making decisions for the QC functional unit.
- Drives timelines and development through broad influence
- Minimal interaction with legal services
- Moderate travel required
- Other duties as assigned
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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
- Eight years relevant (w/4 YR deg) OR four years with relevant graduate degree or certification
- Experience in biologics or gene therapy preferred OR extensive experience in a highly regulated field
- Prior supervisory experience is 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
What you can expect when working at Andelyn.
- The pride in contributing to the development and manufacturing of lifesaving therapies.
- The invaluable experience of being a part of building the foundation of a new organization.
- The opportunity to collaborate with 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.