Senior Analyst, QC Analytical

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

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:

The Senior Analyst QC Analytical 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.

Job 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 support of technology transfers; participate in transfer and qualification/validation studies; participate in equipment qualification/validation studies

  • Review/approve/authorize data and perform analysis and interpretation of test results

  • Participate in deviation and OOS investigations, including troubleshooting of test methods as needed

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

  • Participates in QC inspections and audits as necessary

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

  • Provides guidance to junior staff and applies technical knowledge daily

Other duties as required

Required Qualifications:

  • B.S. degree in Chemistry or Biological Sciences with 5+ years of relevant industry experience or M.S. degree in Chemistry or Biological Sciences with 3+ 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 working with biological products

  • A strong background in HPLC, separation science and physicochemical analysis of proteins and nucleic acids is required. Must have laboratory experience with a variety of analytical techniques including, but not limited to, HPLC utilizing a CDAS application such as Empower, dynamic light scattering, UV-VIS spectroscopy, sub-visible particulate analysis, pH, osmolality and other chromatographic and physicochemical techniques.

  • Proven experience analyzing experimental data, excellent technical writing skills, and must be capable of observing and adhering to lab safety standards and protocols

  • Prior experience utilizing a LIMS system

  • Successfully performs routine work independently with minimal instructions

  • Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion along with 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 and flexibility to cover off-shift work as needed may be required.


  • Knowledge in techniques including ddPCR, qPCR and/or ELISA

Working Conditions

  • This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs

  • This is an on-site role working in a cGMP regulated manufacturing facility

  • On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%)


  • Medical, Dental and Vision Insurance

  • Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

  • 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

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability


Category Sandford TC

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

EOE including Disability/Protected Veterans