QC Scientist I, Microbiology

Astellas is a global life sciences company committed to turning innovative science into value for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology, and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need.

About the role

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. This role will support the AIRM MA-TC GMP Environmental Monitoring (EM) program and microbial testing. The QC Scientist will be responsible for supporting review of EM and lab test results, technical writing/projects, and training/coaching team members.

Responsibilities

• Support day-to-day operations in QC Microbiology laboratories and the GMP facility.
• Review EM, lab test results, and documents for product testing, EM, and trend reports.
• Oversee the trending and reporting of environmental data.
• Serve as an SME/Trainer for microbial testing of media release, product testing for gram staining, pH, bioburden, bacterial endotoxin, and microbial identification.
• Act as an SME for EM/lab assays and assist with assay qualification, instrument troubleshooting, and procedure/report writing.
• Receive manufacturing samples for QC analysis, ship samples to contract labs for testing, and review data for lot disposition.
• Author non-conformance, deviations, and OOS investigations; work with the team to find root causes and corrective actions for out-of-specification results.
• Support cleanroom qualification, gowning qualification, aseptic process qualification, and personnel monitoring for manufacturing activities.
• Author and approve SOPs, protocols, reports, data summaries, and quality systems internally as well as at contract labs and CMOs.
• Support QC equipment validation, maintenance, calibration, and QC laboratories scheduling and maintenance.
• Participate in and own technical projects/documents for process improvement and implementation; experience with rapid assays (CCIT, Mycoplasma, and Sterility) is required.
• Represent QC in cross-functional meetings and provide support/feedback for microbial quality/contamination control of the facility.
• Collaboratively develop and maintain the facility’s contamination control strategy.

Requirements

• B.S. degree in Biology/Microbiology with 8 years or MS with 4 years of relevant industry experience in a QC lab.
• Demonstrated experience with aseptic techniques and common microbiological testing.
• Supports and mentors routine work; helps and coaches the team on testing or technical documents/projects.
• Strong documentation skills, data organization, attention to detail, and commitment to quality and timely batch release.
• Must be capable of observing and adhering to lab safety standards and procedures.
• Excels in a fast-paced team environment and completes assigned work in a timely fashion.
• Strong interpersonal skills; highly collaborative within a multi-disciplinary team and contributes to a supportive and positive work environment.

Preferred Qualifications

• Prior experience in a QC environment, knowledge of cGMPs, and regulatory requirements pertaining to the biotechnology and pharmaceutical industry.
• Alignment with Astellas core values: Be Bold, Care Deeply, and Get Stuff Done—while promoting team culture and compliance.

Location

This position is based in Westborough, MA.

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

Pay

Salary Range: $94,570–$135,100 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience, and organizational equity considerations.)

Schedule

This role is scheduled to work Monday to Friday, first shift (8 am to 5 pm), supporting GMP operations. Flexibility may be required to support GMP operations.