Astellas Pharma
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QC Scientist I Raw Materials
role at
Astellas Pharma .
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.
Purpose 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.
Essential Job Responsibilities
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
Organizational Context The QC Scientist I Raw Materials typically reports to the Senior Manager, Quality Control Raw Materials.
Qualifications Required
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 21CFR, 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.
Preferred
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.
Working Conditions
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.
Salary Range $91,000 – $130,000 (final salary may vary based on experience).
Benefits
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.
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QC Scientist I Raw Materials
role at
Astellas Pharma .
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.
Purpose 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.
Essential Job Responsibilities
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
Organizational Context The QC Scientist I Raw Materials typically reports to the Senior Manager, Quality Control Raw Materials.
Qualifications Required
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 21CFR, 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.
Preferred
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.
Working Conditions
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.
Salary Range $91,000 – $130,000 (final salary may vary based on experience).
Benefits
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.
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