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Astellas Pharma Analyst I, QC Analytical in South San Francisco, California

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines with the potential to deliver transformative value for patients. Based on an innovative scientific approach and industry leading internal manufacturing capability and expertise, we are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown and will also advance additional Astellas gene therapy programs toward clinical investigation. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. Please visit our website at .

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

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 Analyst I join the Quality Control Analytical group. The Analyst I will be responsible for implementing and executing analytical testing in support of clinical and commercial viral vector products in compliance with GMP requirements. The Analyst I will also support testing for stability studies, methods validation/qualification, method transfer studies and equipment validation. This role will be located in our South San Francisco Quality laboratories.

Primary Responsibilities

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

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

  • Perform analytical testing in supporting technology transfers

  • Review data and performs analysis and interpretation of test results

  • Participate in method development, transfer, and qualification/validation studies

  • Participate in equipment qualification/validation studies

  • Participate in deviation and OOS investigations

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

Must Have/Required

  • B.S. degree in Biological Sciences plus 1+ years of relevant industry experience or M.S. degree in Biological Sciences plus 0-1+ years of relevant industry experience in quality control role

  • Prior experience in GMP QC environment and strong understanding of data integrity requirements and regulatory requirements pertaining to biotechnology and pharmaceutical industries

  • Demonstrated experience in molecular/cell biology required

  • Prior laboratory hands-on experience with a variety of analytical techniques including, but not limited to, ddPCR, qPCR, DNA/RNA purification/detection, protein quantification, ELISA and Western Blotting

  • Demonstrated experience with mammalian cell culture and cell-based assays

  • Proven experience analyzing experimental data

  • Excellent technical writing skills

  • Must be capable of observing and adhering to lab safety standards and protocols

  • Successfully performs routine work independently with minimal instructions

  • Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion

  • Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment

  • Highly self-motivated and goal oriented

  • This role is scheduled to work during normal business hours, typically starting at 7:30 AM, Monday -- Friday

  • Occasional weekend work may be required

May Have/Preferred

  • Experience with U/HPLC techniques (e.g., RP- & SEC) with Empower software knowledge is highly recommended


  • Medical, Dental and Vision Insurance

  • Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

  • 401(k) match and annual company contribution

  • Company paid life insurance

  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

  • Long Term Incentive Plan for eligible positions

  • Referral bonus program

Category DP Manufacturing

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans