Senior Process Development Engineer, Downstream

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.astellasgenetherapies.com

About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

Our Values:

• Be BOLD (Find a Way)
• Care Deeply -- for our patients, each other and our work
• #GSD (Get Stuff Done)THE ROLE

Reporting to the Senior Manager, Downstream Process Development, this position will contribute to the design, development, and optimization of the processes for manufacture of our Adeno-Associated Virus (AAV) vectors for human gene therapy. The Senior Process Development Engineer, Downstream will be responsible for the design and implementation of processes, instrumentation, and equipment from the laboratory through pilot plant and manufacturing scales, as well as assisting the manufacturing operation in problem solving with regards to equipment and systems. This is a hands-on laboratory-based position located in South San Francisco.

RESPONSIBILITIES

• Plan, execute, and analyze lab scale/pilot scale experiments to evaluate new process technologies.
• Experience with scale up/scale down, and tech transfer to manufacturing.
• Maintaining digital records of all activities using in-house systems and shared digital document repositories.
• Use of statistics to design experiments and analyze data
• Generate technical reports to summarize results of evaluations
• Ensure safe laboratory operations and good documentation practices
• Contribute to planning operations and scheduling activities
• Critically review external vendor offerings applied to viral vector and plasmid production