Senior/ Principal Process Engineer/ Process Development Scientist, Process Innovation

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Job description

Why Work for Us

Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you'd like to be a part of this important mission, please apply to join our team.

About Astellas Gene Therapies

Astellas Gene Therapies is 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 the 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: .

Our Values:

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

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

Reporting to the Senior Director, Process Development, this position involves a unique opportunity to work in a process development cross cutting role, identifying and testing new technologies that enhance development strategies and manufacturing processes. In this role the engineer/' scientist will collaborate with research, process engineering, pilot plant, and vector manufacturing groups to realize impactful technology. This role will be located in South San Francisco.

Primary Responsibilities

• Designs and implements industry leading innovative solutions on assignments highly complex in scope spanning upstream and downstream process development, engineering, instrumentation, and manufacturing process/scale up in which analysis of data requires expert knowledge to evaluate a variety of complex/unknown factors
• Exercises judgment without requiring defined practices and policies to select methods and techniques for obtaining solutions
• Can manage many tasks/projects at one time meeting timeline goals
• Independently determines methods and procedures, proposes new ideas, and problem solves across upstream, downstream process development, and manufacturing
• Collaborates with senior scientists/colleagues in research, technical operations, and regulatory to develop solutions to complex cross-functional issues
• Performs statistical analysis of process development results and manufacturing data, and communicates process knowledge
• Identifies and tests innovative scientific methodologies/processes and technologies that benefit process development strategies and manufacturing speed, quality and COGS goals
• Highly skilled at communicating complex, scientific information to technical and non-technical audiences
• Generates CMC sections of regulatory filings, assists with QA investigations as needed
• Represents PD as an SME and Project team member for early and late stage programs
• Works with group mangers to Drive technical innovation in downstream process development to increase the speed of process development to provide high productivity, high quality, and predictable manufacturing processes

About you

Must Have/Required

• A minimum of 6 years of relevant experience (14+ with B.S., 12+ with M.S., 6+ with Ph.D.) successfully working in process development in the biopharmaceutical industry with proven track record of manufacturing technology development
• Extensive experience in either upstream or downstream Process Development of biopharmaceutical drug substance. Preference for experience in both upstream and downstream process development
• Experience with late and commercial stage biologics, with experience in process development, process characterization, PPQ, and other BLA enabling studies and CPV programs
• Strong background in statistical design of experiments (DoE) and associated analysis
• Positive, professional attitude with a passion for science
• Outstanding collaboration, problem solving team player with excellent communication and organizational skills
• History of managing multiple projects simultaneously while meeting project deadlines in fast moving environment
• Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done - is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

May Have/Preferred

• Prior AAV gene therapy vector or other viral particle production experience

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.