Engineer II, Process Development, Downstream

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

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.

The Role:

The primary purpose of the Process Development Engineer II role is to work with the Downstream Process Development team by executing studies and ensuring proper capture of data. The Process Development Engineer is expected to develop and drive projects forward from a technical perspective. Additional responsibilities include maintaining the labs and driving initiatives to improve lab efficiency.

Responsibilities:

• Executes purification studies at various scales and unit operations.


• Develop purification steps including but not limited to chromatography, tangentially flow filtration, normal flow filtration, clarification, lysis etc.…


• Capture study data in appropriate formats (including paper records, digital repositories), ensuring Good Documentation Practices are followed.


• Contributes to Process Development technical projects as assigned by manager.


• Prepares study buffers and reagents.


• Ensures lab instruments are maintained in proper working state by performing routine maintenance and coordinating vendor reports.


• Adheres to Process Development SOP/DOP documents.

Organizational Context:

• This position reports to the Team Lead, Downstream Process Development.


• This position is an individual contributor role.


• This position requires onsite work.