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: www.astellasgenetherapies.com.
* 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.
As part of the Astellas Gene Therapies Research & Technical Operations Organization's Enterprise Engineering & Facilities team, the process engineer will report to the pilot plant manager and will provide technical engineering leadership in support of pilot plant day to day operations producing both scale up and test article material for non-clinical use and deployment of new equipment, systems, and processes of varying complexity while meeting safety, sustainability, and quality objectives. Responsibilities will include execution of test article production, engineering runs, and new process equipment evaluation. The role will include close collaboration with Process Development, Lab Management, Project Engineering, MSAT, and external vendors. This position is located in South San Francisco, CA.
* Author process descriptions, technical reports, test plans, batch documentation, and SOPs in support of process scale up, tech transfer, and test article production activities
* Lead the evaluation and incorporation of new technologies and methods improvements at the pilot plant and stay current with advances in technologies and engineering best practices
* Perform routine troubleshooting on pilot plant equipment and systems and coordinate with facilities and lab operations teams to ensure equipment and facility is properly maintained
* Assist with defined process development experiments and process engineering scale up initiatives and ensure a safe and organized work environment for both self and colleagues is maintained at all times
* Execute non-clinical test article production in accordance with procedures, schedule, and material supply needs and at-scale production runs to test and verify new technologies and processes
* Ensure timely turnaround and reporting of data to inform knowledge transfer to process recipients, facilitating sample submission processing for analytical testing, as required.
* Work with enterprise engineering and PMO colleagues in the planning and execution of manufacturing new equipment introductions and facility fit evaluations
* Lead engineering activities as they pertain to pilot plant changes and equipment acquisition (equipment design/commissioning, consumables design/procurement, tech transfer)
* Support cross site engineering forums focused on promoting collaboration, process performance review, gap remediation, single use technology program development, and continuous improvement initiatives
* Define, initiate, and execute project-related change control processes with input from cross functional team members and coordinate with multiple interdisciplinary groups, as required
* May mentor and train junior pilot plant engineers and associates
* BS in Chemical/Mechanical/Biological Engineering or other life science discipline with minimum of 5 years of relevant experience, or minimum of 3 years with MS
* Thorough knowledge of equipment and systems used for bioprocess operations
* Demonstrated history of working independently, and managing multiple projects
* Demonstrated ability to learn and apply new engineering disciplines
* Experience leading or supporting commissioning and qualification-related activities such as FAT, SAT, and IQ/OQ
* Experience with scale-up/scale-down and tech transfer
* Self-reliant, a good problem solver, and results oriented
* Demonstrated success and desire to work with a diverse team in a fast-paced environment under challenging timelines
* Strong attention to detail supported by excellent time management and organizational skills
* Proficiency with MS Office (Excel, PowerPoint, Word, Project, and Visio).
* Must be willing to work a flexible schedule and be on-call to support onsite teams, as needed. This could include, evenings, weekends and holidays, as needed
* Models our Core Values: Be Bold, Care Deeply, #GetStuffDone -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted
* Experience leading or supporting facility startup engineering activities
* Experience with single-use equipment and systems
* Detailed knowledge of cGMPs and good documentation practices (GDP)
* Experience with process equipment and facility design
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
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