GMP Senior Scientist

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 Pioneering Solutions that Turn Hope into Reality™ through our ACCTS ions. A CCOUNTABLE in our actions. 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 GMP Senior Scientist is responsible for leading production activities within a cGMP clean room environment. This role will closely collaborate with Operational Leadership on daily priorities and provide hands-on leadership for production activities, production, and project timelines, as well as staffing requirements. Senior Scientists are looked to be the subject matter experts and will ensure training, documentation, and regulatory and fiscal compliance. Expect excellence from the production team. Lead from a position of influence, coaching, and collaboration alongside production staff. Assign tasks to production staff to ensure schedules and metrics are met for client and company deliverables. Conduct adherent and suspension cell line scale-up to support ongoing large-scale manufacturing. Troubleshoot production issues, escape all needs and provide potential resolutions to maintain successful production activities Work with the supply chain to requisition and dispose of materials. Ensure material timelines are met to achieve production goals. Create, lead, and manage change requests (CR) and corrective and preventive actions (CAPA) needed to ensure production changes and improvements are implemented in a timely manner. Lead all aspects of the production documentation/client batch record requirements, adhering to GDP standards set forth by the company. Regularly engage with QA staff and management to investigate deviations in manufacturing processes. Actively engage with project teams to bring new projects and processes to GMP production in a timely manner. Respond to equipment alarms for relevant areas, escalating issues as required to ensure product quality and safety. Operate with high regard to all policies and procedures to ensure adherence to regulatory and quality standards. Exercise great attention to detail, integrity, discretion, leadership, and personal responsibility. Utilize clear and concise communication to deliver high productivity and contribute to the success of the team and its goals. Moderate involvement in audits, inspection outcomes, and client communications. Mentor and develop other Operations staff. All other duties assigned. What you bring to the team. Must possess a relevant four-year degree OR relevant Masters OR relevant PhD, background in the life sciences, biotechnology or gene therapy industries preferred. Working knowledge of team function within the organization. First-level leadership. Coordinates and leads daily team activities. May spend a portion of time performing the work of those they supervise. Prior supervisory experience is preferred. Excellent detailed knowledge of cGMP, GLP, and FDA guidelines 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. 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. #J-18808-Ljbffr Andelyn Biosciences