Job Description
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. 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 thedevelopment and manufacturing of innovative therapies to bring more treatments to more patients. We are Turning Hope Into Reality™ through our ACCTS ions. A****CCOUNTABLE in our actions. C****URIOUS to discover. C****OMPASSIONATE in our thinking. T****RUSTWORTHY in our communications. S****UPPORTIVE of one another. Employees are expected to perform the following essential functions under the framework of our ACCTS ions. What you will do. 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 skilled at aligning development and clinical manufacturing with commercial goals during client discussions. 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 facilitating multifunctional teams, and ensuring the successful delivery of complex customer projects. 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 Utilize project management tools and processes Operate within the Quality Management System applicable to the manufacture of phase 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 Moderate travel required Occasional involvement in audits Consistent involvement in customer relations 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 Must be highly skilled in Project Planning software (Smartsheet preferred) Ability to work independently as well as collaboratively in a diverse and inclusive work environment Must possess a client-focuse