Metrologist

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 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] .

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 Facilities Metrology Supervisor, the Metrologist will be part of the SSF Site Operations Facilities & Engineering department supporting Manufacturing, Laboratories, Warehouse, and administrative facilities. This position will be part of a team that ensures proper calibrations are completed on time, in a GxP environment. Astellas Gene Therapies’ facilities are where groundbreaking products begin the journey to saving lives. This area of Astellas Gene Therapies offers the chance to collaborate in the purest form as you work alongside a diverse range of highly motivated and passionate people to develop state-of-the-art facilities. What you do will be fulfilling, impactful and meaningful – not least, you will be helping to deliver radical therapies to hopeful patients. The role is primarily located in South San Francisco, CA.

Responsibilities

• Perform routine or non-routine preventative maintenance
• Troubleshoot instrumentation issues and/or replace instrument as needed
• Third party vendors management/assistance
  • Third party vendors work onsite at AGT facilities
    • Coordinate for their onsite visit and make sure the instrumentation to be calibrated are ready with end user approval
    • Ensure the calibration documentation are received in timely manner
    • Ensure the performance of the third party met AGT’s requirement
    • Review and approve calibration document result
    • Follow AGT’s SOP to ensure the calibration document are uploaded/stored at the appropriate system
  • Third party vendors work outside AGT facilities
    • Coordinate to get the instrumentation properly collected, cleaned, packed and shipped to the vendor
    • Ensure the calibration work is performed in timely manner and calibrated instrumentation are returned in the original condition when shipped out
    • Review and approve calibration document result
    • Follow AGT SOP to ensure the calibration document are uploaded/stored at the appropriate system
• Ensure safe and compliant day-to-day operations of utility and support systems including use of BAS. Ensure facilities are fit for use by maintaining cGMP and safety standards.
• Respond to high priority service calls and document detailed service reports
• Provide input for creation and revision of calibration plans, spare parts inventory, and SOPs.
• Partner with internal customers and suppliers, colleagues and support services to achieve department goals.
• Document technical work performed accurately and completely.
• Understand and adhere to internal and external regulations, procedures & policies.
• Effectively communicate safety, quality, technical and training issues to team.
• Enforce and follow all safety rules and regulations.
• Interact with stakeholders, and vendors