GMP Plasmids 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 OMPASSIVE

T RUSTWORTHY

S UPPORTIVE

Employees are expected to perform the following essential functions under the framework of our ACCTS ions. What you will do. The GMP Plasmids Senior Scientist is responsible for guiding all aspects of Good Manufacturing Practices (GMP) and production in the Clinical Manufacturing Facility (CMF). Working in close collaboration with the GMP Plasmids Supervisor, the Senior Scientist will provide hands‑on support and leadership for all day‑to‑day GMP production operations, including project timeline management and personnel. The Senior Scientist will aid in production efforts to deliver all products in a timely, compliant, and fiscally responsible fashion by providing leadership to staff working in the manufacturing facility as well as hands‑on training to facilitate operations consistently following appropriate practices, batch records, and Standard Operating Procedures (SOPs) for manufacturing. Provide leadership in daily operational activities related to the GMP manufacturing of biological products by leading and executing production processes, including assuring the availability of materials and the proper documentation surrounding GMP activities and product quality. Work with GMP Management to enact the strategic direction of the GMP area. Maintain compliance with applicable regulatory requirements for cellular and gene therapy products. Set and maintain a professional standard within the GMP area. Mentor, train, and supervise junior staff to assure the proper operation of facility equipment as well as the adherence to appropriate and accurate documentation surrounding activities and product quality. Guide the Operations Staff in deviation investigations, OOS results, and process troubleshooting while working with GMP management and Quality Assurance. Collaborate with GMP Management to ensure new projects and technologies are sought for incorporation into the GMP area. Work with Management to ensure continuous improvement objectives are identified and met using metrics and other statistical means. Support GMP resources and the supply chain, including maintaining materials inventory to meet production goals. Write and review the creation and maintenance of Standard Operating Procedures that affect the conduct of operations within the Plasmid laboratory (equipment and process SOPs) and ensure they are written with proper scope, detail, and format to meet guidance. Work to specific measurable objectives requiring operational planning skills with little direct supervision. Solve, correct, and prevent problems, perform tasks as assigned by leadership, and delegate tasks to junior staff. Work with management to answer client questions regarding their product. Exercise discretion, judgment, and personal responsibility Operate within the management System applicable to the manufacture of phase appropriate material Demonstrate a high level of integrity Attention to detail in all job functions Make decisions based on established procedures Moderate involvement in customer relations Influences hiring, development and related personnel processes Other duties as assigned What you bring to the team. Must possess relevant four-year degree OR relevant Masters OR relevant PhD, background in the life sciences, biotechnology or gene therapy industries preferred Five years relevant (w/4 YR deg) OR two years (w/Masters) Experience in biologics or gene therapy (plasmid manufacturing preferred) Experience in highly regulated field 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 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 that 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 Paid Holidays plus 2 floating holidays annually. Company-paid 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