Senior Program Manager
Valid8 Financial, Inc.
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 development and manufacturing of innovative therapies to bring more treatments to more patients. We are Turning Hope Into Reality™ through our ACCTS actions. Employees are expected to perform the following essential functions under the framework of our ACCTS actions. The Sr. Program Manager supports 6‑8+ client programs, with up to 3 client programs in the cGMP 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 integrating agreements, development programs, and clinical manufacturing client discussions with an eye toward 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 Assessing and costing new customer project opportunities Ensuring project execution is performed in compliance with existing procedures Build and maintain project management tools and processes Operate within the Quality Management System applicable to the manufacture of phase‑appropriate material in the facility Maintain compliance with applicable regulatory requirements for cellular and gene therapy products Performs in accordance with established policies, procedures, and techniques Anticipating problems and removing obstacles to enable staff to perform tasks as assigned Work on 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 Developing and enforcing procedures and controls Approval of procedures established by junior staff Has moderate budgetary responsibility Consistent involvement in customer relations Responsible for hiring, development, and related personnel processes. Mentoring and professional development of staff 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 Eight years relevant (with 4 YR degree) OR four years 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 Exercise discretion, judgment, and personal responsibility Demonstrate a high level of integrity Exercise crucial people skills Ability to manage and influence people in the direct and lateral support structure Attention to detail in all job functions 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. We are required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self‑identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at #J-18808-Ljbffr Valid8 Financial, Inc.
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