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 the development 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.

ACCOUNTABLE in our actions.

COMPASSIVE

TRUST WORTHY

SUPPORTIVE

Employees are expected to perform the following essential functions under the framework of our ACCTS
ions.

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…