Scientist II - Plasmid Production

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. ACCOUNTABLE in our actions. 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 ACCTS ions. Scientist II will be responsible for the execution of Good Manufacturing Practices (GMP) Plasmid production . Working in close collaboration with management and senior staff, Scientist II will execute all aspects of day-to-day production operations, including the execution of production processes and documentation. Scientist II documentation: They will be able to lead and coordinate their execution. Secondary responsibilities include technical review of documentation, assisting with investigations, SOP generation or revision, training of junior staff, and other tasks needed to support the primary responsibilities. What you bring to the team. Responsible for assisting and leading operations in the support of the production of plasmid product Respond to, and take action from, alarm notifications from the applicable monitoring system(s) for laboratory temperature-controlled storage units that occur at any point during the assigned period of responsibility Works in close collaboration with Management and Senior Staff to support the strategic direction of the GMP area including determination of schedule and project timelines/capabilities Responsible for setting and maintaining a professional standard Responsible for leading and performing daily operational activities related to the manufacturing of biological products, by executing production processes including assuring the availability of materials and the proper documentation surrounding activities and product quality Exercise discretion, judgment, and personal responsibility Anticipate, solve, correct and prevent problems including error trending and CAPA implementation Draft and revise SOPs and controlled documents Demonstrate a high level of integrity Operates within the Quality Management System applicable to the manufacture of phase appropriate material Maintain compliance with applicable regulatory requirements for cellular and gene therapy products Attention to detail in all job functions Operates in alignment with established policies, procedures, and techniques, requiring relevant training, practical experience, or a working knowledge of the tasks involved. Works in a diverse and collaborative team environment utilizing clear communication to deliver high productivity and contributes to the success of team and goals Adhere to Good Documentation principles and ALCOA in the support of all production activities Nominal fiscal responsibility May require some travel Limited involvement in audits Limited involvement in customer relations Limited responsibility for inspection outcomes 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 Three years relevant (w/4 YR deg) OR 2 years relevant experience with (w/Masters) Knowledge and experience in aseptic technique, fermentation, cell culture, liquid separation techniques, and/or fluid handling Experience in Biologics, Gene Therapy, or Plasmids required. Experience in 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 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 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