QC Scientist I, Microbiology

Astellas Pharma; Westborough (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company is seeking a QC Scientist I in Microbiology to support GMP operations at their Westborough site. The role involves overseeing environmental monitoring, microbial testing, and ensuring compliance with industry standards. Ideal candidates will have a strong background in microbiology and quality control, with experience in aseptic techniques and documentation.

Qualifications

• 8 years industry experience with BS or 4 years with MS in QC.
• Experience with aseptic techniques and microbiological testing.

Responsibilities

• Support daily operations in QC Microbiology laboratories.
• Review EM, lab test results, and documentation.
• Author investigations for non-conformance and deviations.

Skills

Aseptic Techniques

Microbiological Testing

Documentation

Attention to Detail

Interpersonal Skills

Education

BS in Biology/Microbiology

MS in Biology/Microbiology

Job description

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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. 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. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, including macular degeneration and other ocular indications, vascular, and autoimmune diseases. AIRM's intellectual property portfolio includes pluripotent stem cell platforms and other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

This role is based at the Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA, and is titled QC Scientist I, Microbiology.

Purpose

QC Scientist, Microbiology will support the AIRM MA-TC GMP Environmental Monitoring (EM) program and microbial testing. Responsibilities include reviewing EM and lab test results, technical writing, projects, and training team members. The schedule is Monday to Friday, 8 am to 5 pm, supporting GMP operations.

Essential Job Responsibilities

• Support daily operations in QC Microbiology laboratories and the GMP facility.
• Review EM, lab test results, and documentation for product testing, EM, and trend reports.
• Oversee trending and reporting of environmental data.
• Serve as SME/Trainer for microbial testing, including media release, product testing (gram staining, pH, bioburden, bacterial endotoxin, microbial ID).
• Assist with EM/lab assay qualification, troubleshooting, and documentation.
• Receive, ship, and review manufacturing samples for QC analysis and lot disposition.
• Author investigations for non-conformance, deviations, and OOS, working on root cause and corrective actions.
• Support cleanroom and personnel qualification activities.
• Author and approve SOPs, protocols, reports, and data summaries.
• Support QC equipment validation, maintenance, calibration, and scheduling.
• Lead technical projects for process improvements, with experience in rapid assays (CCIT, Mycoplasma, Sterility).
• Represent QC in cross-functional meetings, providing microbial quality and contamination control feedback.
• Develop and maintain contamination control strategies for the facility.

Qualifications

• BS in Biology/Microbiology with 8 years or MS with 4 years of industry experience in QC.
• Experience with aseptic techniques and microbiological testing.
• Ability to mentor and support testing and technical documentation.
• Strong documentation, data organization, and attention to detail.
• Adherence to lab safety standards.
• Ability to work efficiently in a fast-paced team environment.
• Excellent interpersonal skills and collaboration.
• Availability for day shift, Monday to Friday, with flexibility for GMP support.

Preferred Qualifications

• Prior QC experience, knowledge of cGMPs and industry regulations.
• Alignment with core values: Be Bold, Care Deeply, Get Stuff Done, fostering team culture and compliance.

Working Conditions

• Long hours sitting, standing, and manual tasks, including bending, stooping, lifting up to 35 lbs.
• Gowning required inside cleanrooms.
• Use of PPE to prevent biohazard exposure.
• On-site role in a cGMP manufacturing facility.