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.

The Plasmid Development Senior Scientist is responsible for aiding development activities within the Pre-clinical Plasmid team. The Senior Scientist has a working knowledge of microbial systems, bacterial metabolism, current bioprocessing technologies, and preferably has a track record of developing processes for expression of plasmid DNA using microbial fermentation systems.
Working in close collaboration with leadership, the Senior Scientist Responsibilities include devising and executing various development projects for both upstream manufacturing and downstream purification of plasmid DNA. The Senior Scientist will also be expected to contribute to developing and reviewing procedures and Batch Record forms for fermentation processes as well as assist in the technical transfer of fermentation processes from process development to research grade and GMP manufacturing.

Additionally, the Senior Scientist will troubleshoot issues as well as trend Critical Process Parameters and Critical Quality Attributes to aid in control of the process. Trend errors and work with management to implement the appropriate CAPAs to drive process improvement.

• Identify and Coordinate development of experiments to fill knowledge gaps
• Responsible for providing technical guidance in daily operational activities related to the development of manufacturing processes.
• Leads and supports a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of team and goals.
• Work with vendors to design and source new materials
• Anticipate and troubleshoot issues with operations to avoid interruptions in production
• Work with management to answer client questions regarding their product
• Solving, correcting, preventing problems, and performing tasks as assigned by leadership, as well as delegating tasks to junior staff
• Work to specific measurable objectives requiring operational planning skills with little direct supervision
• Responsible for the mentoring, training, and supervision of junior staff to ensure the proper operation of facility equipment as well as the adherence to appropriate and accurate documentation surrounding activities and product quality
• Works in close collaboration with Management to ensure continuous improvement objectives are identified and met using metrics and other statistical means
• Works in close collaboration with Management to ensure new projects and technologies are sought for incorporation into the Plasmid area
• Exercise discretion, judgment, and personal responsibility
• Demonstrate a high level of integrity
• Maintain a positive attitude
• Attention to detail in all job functions
• Performs in accordance with established policies, procedures, and techniques and requires training, common experience or working knowledge related to the tasks performed
• Documentation of all development activities performed according to SOPs
• Make decisions based on established procedures
• Has fiscal responsibility
• Infrequent travel required
• Moderate involvement in audits
• Moderate involvement in customer relations
• Moderate responsibility for inspection outcomes
• Influences hiring, development, and related personnel processes
• Mentoring and professional development of staff
• Other duties as assigned