Sr. QC Biochemical Operations at Astellas in Sanford, North Carolina

Job Description:

Sr. QC Biochemical Operations

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

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: www.astellasgenetherapies.com.

The Role

Astellas Gene Therapies is seeking an experienced Senior Analyst to join the Quality Control Biochemical Operations group. The Senior Analyst will be responsible for implementing and executing analytical testing in support of clinical and commercial products in compliance with GMP requirements. The Senior Analyst will also support testing for stability studies, methods validation/qualification, method transfer studies and equipment validation.

Responsibilities

• Perform release, stability, and in-process testing in supporting production activities


• Author/revise technical reports and laboratory procedures (SOPs and methods)


• Perform analytical testing in supporting method transfer/validations


• Review/authorize data and performs analysis and interpretation of test results


• Participate in method development; equipment qualification/validation studies; deviation and OOS investigations; troubleshoot methods, as needed


• Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration


• Participates in QC inspections and audits as necessary


• Assists in the preparation and review of CMC regulatory submissions as needed


• Support and mentor junior team members


• Other duties as required

Quantitative Dimensions:

• The Senior Analyst, Quality Control Biochemical Operations is responsible for implementing and executing analytical testing, support testing for stability studies, methods/validation/qualification, method transfer studies, and equipment validation.