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 a Specialist to join the US Method and Tech Transfer group. The primary purpose of the Specialist, US Method and Tech Transfer role is to 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. The role includes yet is not limited to contract test lab managements, support test method validation/co-validation/transfer/qualification/verification, and as appropriate, document management and revision in support of commercial viral vector products in compliance with cGMP requirements. This role typically reports to the Manager, Associate Director, or Director QA, US Method and Tech Transfer. As determined by the manager, this role may be located at the South San Francisco, CA manufacturing facility or Sanford, NC manufacturing facility. This role is typically on on-site role and based on business assessment, may be considered as a hybrid role.

Primary Responsibilities

• Responsible for contract testing lab (CTL) schedules
• Regularly interacts with CTLs and Site QC teams to ensure timely testing of samples
• Initiates work orders and purchase orders for contract lab testing
• Serves as the single point of contact between Astellas and CTLs to review protocols and reports, routine testing data, and investigations from a technical perspective.
• Leads internal CTL investigations: deviations, invalid results, unexpected results, OOS/OOT, lab investigations, and contract lab discrepancies
• Authors and manages change controls
• Partners with the South San Francisco QC laboratory, Sanford QC laboratory, and Analytical Development to draft transfer, verification, qualification, and validation protocols and reports in support of new product introduction into the Sanford and SSF sites.
• Ensures compliance with applicable cGMP regulations, ICH guidelines, and SOPs, and supports internal and regulatory audits

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