Senior Bioassay Specialist, US Method and Tech Transfer
Astellas

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 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

Astellas Gene Therapies is seeking an experienced Senior Bioassay Specialist to join the US Method and Tech Transfer group (QC). Reporting to the Director, US Method and Tech Transfer, the Senior Bioassay Specialist will lead the following functions in the Method and Tech Transfer group with respect to regulatory and quality requirements for the Company's development and production of pre-clinical, clinical, and commercial therapeutics: bioassay test method transfer/qualification/validation testing, bioassay reference material/critical reagent standards and controls programs, assay troubleshooting, and as appropriate, document management and revision. This is a hands-on role that will involve close collaboration with and active support of the Quality Control, Quality Assurance, Regulatory, and Analytical Development groups. This role will be located in our South San Francisco, CA or Sanford, NC manufacturing facility.

Primary Responsibilities

• Proficiently execute bioassay techniques such as ELISA and cell-based assays

• Serve as the QC single point of contact between transferring and receiving laboratories for laboratory activities associated with new product introduction/transfer.
• Coordinate all laboratory readiness activities for incoming Bioassays including training material and SOP creation, initial reagent/supply identification/procurement by partnering with teams including the QC and Analytical development groups
• Partner with the South San Francisco QC laboratory, Sanford QC laboratory, and Analytical Development to co-validate/transfer bioassays in support of new product introduction into the Sanford and SSF sites.
• Draft transfer, qualification, and validation protocols and reports

• Lead bioassay investigations and troubleshooting
• Author and manage change controls
• Develop subject matter expertise on assigned bioassays

• Assist in the preparation and review of CMC regulatory submissions.
• Ensure compliance with applicable cGMP regulations, ICH guidelines, and SOPs, and support regulatory audits

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