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Job Details


Associate Engineer

Pharmaceuticals

All

Full Time

On Site

No

South San Francisco, California, United States

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: [Register to View]

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 [Register to View] style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">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)

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

As part of the Astellas Gene Therapy Center of Excellence (GTCOE) Engineering & Facilities enterprise team, the Associate Engineer will support day-to-day operations in our brand-new South San Francisco based Pilot Plant. The Pilot Plant affords a flexible, dynamic environment to execute small scale bioprocess operations for non-clinical material supply and to test innovative new processes and equipment to enable the next generation of manufacturing processes at Audentes. 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.

Primary Responsibilities

  • Support drafting of batch documentation, SOPs, experimental test plans, and reports
  • Coordinate with facilities and lab management to ensure equipment is properly maintained
  • Partner with lab management to ensure raw material stocks are maintained to support lab needs
  • Perform routine troubleshooting on Pilot Plant equipment and systems
  • Partner with Process Engineering and MSAT to communicate process performance
  • Maintain a safe and organized work environment for both self and colleagues
  • Execute non-clinical test article production in accordance with procedures, production schedule, and material supply needs
  • Execute at-scale production runs to test and verify new technologies and processes
  • Assist with defined process development experiments and process engineering scale up initiatives
  • Assist in the evaluation and incorporation of new technologies
  • Ensure timely turnaround and reporting of data to inform material allocation strategy and knowledge transfer to process recipients
  • Coordinate with analytical testing groups on sample submission and testing from experimental and production runs
  • Contribute to process and facility continuous improvement initiatives and implementation of such plans
  • Other lab duties as assigned