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 .

Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products.

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

Astellas is announcing a System Administrator opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose

The System Administrator supports the implementation, operation, and maintenance of digital and computerized systems within a cGMP manufacturing environment. Acting as the primary link between Operations and IT, this role manages system configuration, user access, and master data for core applications such as LIMS and EBR. The position ensures ongoing data integrity and 21 CFR Part 11 compliance across manufacturing and laboratory systems.

Essential Job Responsibilities

Administer and maintain site computerized systems, including configuration, access control, and master data management.
Serve as first-line support for user issues and coordinate system troubleshooting, change control, and periodic maintenance.
Develop and maintain documentation including URS, configuration guides, validation protocols, SOPs, and training materials.
Partner with IT, QA, and system vendors to manage system qualification (IQ/OQ/PQ), updates, and change management activities.
Ensure systems operate in compliance with cGMP and data integrity standards; support internal/external audits and inspections.
Support onboarding and training for system users and monitor compliance metrics for continuous improvement.

Quantitative Dimensions

This role directly impacts digital system uptime, data integrity, and compliance readiness. The position collaborates closely with IT technical leads to ensure systems operate reliably and efficiently in a validated state.

Organizational Context

Reports to the Associate Director, Manufacturing Technical Support. Collaborates cross-functionally with IT, QA, Validation, and Manufacturing teams to maintain compliant, validated, and reliable systems in support of Astellas mission.

Qualifications

Required:

B.S. in biological sciences, chemistry, or related field with 5+ years (or M.S. with 3+ years) experience managing analytical or manufacturing computerized systems.
Strong knowledge of GMP, 21 CFR Part 11, and data integrity principles.
Experience with LIMS and/or EBR system administration and validation.
Familiarity with Windows environments, networks, and laboratory system integration.
Excellent technical writing, communication, and troubleshooting skills.
Demonstrated ability to work collaboratively and manage multiple priorities in a regulated setting.

Preferred

Experience in a fast-paced, high-growth biopharma or gene therapy environment.
Experience with additional digital platforms (SAP, BMRAM, Labware LIMS, Tempo).
Hands-on experience with instrument integration or data capture workflows.

Working Conditions

Experience in a fast-paced, high-growth biopharma or gene therapy environment.
Experience with additional digital platforms (SAP, BMRAM, Labware LIMS, Tempo).
Hands-on experience with instrument integration or data capture workflows.

Salary Range : $79,800-$125,400 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)

Benefits

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
Company fleet vehicle 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.

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Category Massachusetts TC

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

EOE including Disability/Protected Veterans

Astellas Pharma

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