QC Scientist Raw Materials

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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.

The Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focuses on the development and commercialization of stem cell and regenerative medicine therapies.

The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead and mentor junior analysts.

• Develop, author, and revise technical reports and laboratory procedures (SOPs, methods)
• Execute and troubleshoot raw material testing in support of production activities
• Perform routine release sampling and manage testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures
• Design and perform testing in support of method transfer, validation, qualification, and verification
• Review, authorize data, and perform analysis and interpretation of test results and trends
• Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations
• Perform QC lab support activities including sample management, reagent preparation, instrumentation maintenance, and instrument calibration
• Support and mentor junior team members
• Collaborate with other network sites to share best practices
• Complete other duties as required

The QC Scientist I Raw Materials typically reports to the Senior Manager, Quality Control Raw Materials.

• B.S. degree in chemistry, biological sciences or related field with 6+ years of relevant experience in a GMP Quality Control role, or M.S. degree with 4+ years of relevant experience.
• Prior laboratory hands‑on experience with a variety of techniques such as FTIR, Raman, Near‑IR, HPLC analysis and other compendial assays.
• Technical knowledge of 21
  
  CFR, ICH, USP, Ph. Eur. and FDA guidance documents and cGXPs in support of clinical and commercial manufacturing.
• Proven knowledge in cGMP raw material program (sampling plans and testing requirements).
• Knowledge of data integrity requirements and regulatory requirements for biotechnology and pharmaceutical industries.
• Experience using LIMS as an end user.
• Excellent technical writing and verbal communication skills.
• Adherence to lab safety standards and procedures.
• Ability to work independently with minimal instructions.
• Strong interpersonal skills and collaborative mindset.
• Self‑motivated and goal‑oriented, capable of handling multiple tasks in a fast‑paced environment.
• Demonstrated quality standards and readiness for additional duties or special projects.

• Experience in a biotech/pharmaceutical company with a high‑growth, fast‑paced environment.
• Experience in qualification of analytical equipment, including computerized systems.
• Experience in method validation, qualification, verification, and transfer.

• Requires long periods of sitting, standing, and use of hands; regular motion including bending, stooping, lifting up to 20 lbs.
• On‑site role in a cGMP regulated manufacturing facility.

$91,000 – $130,000 (final salary may vary based on experience).

• Medical, Dental and Vision Insurance
• Generous Paid Time Off (Vacation, Sick time, national holidays, including Heritage Days, and Summer/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 disability. Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.