Quality Control Scientist I

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. Learn more at Astellas.com.

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

QC Scientist, Microbiology will provide support to the AIRM MA-TC GMP Environmental Monitoring (EM) program, and microbial testing. QC Scientist will be responsible for supporting review of EM and lab test results, technical writing/projects, and training/coaching team members. This role is scheduled for Monday to Friday First shift (8 am to 5 pm) supporting GMP operations.

• →Support day-to-day operations in QC Microbiology laboratories and the GMP facility.
• →Reviews EM, lab test results, and documents for product testing, EM, and trend reports.
• →Oversee the trending and reporting of environmental data.
• →Be an SME/Trainer for microbial testing of media release, products testing for gram staining, pH, bioburden, bacterial endotoxin, and microbial identification.
• →Be an SME for EM/lab assays and help with assay qualification, instrument troubleshooting, and procedure/report writing.
• →Receive manufacturing samples for QC analysis, ship samples to the contract labs testing, review data for lot disposition.
• →Author any non-conformance, deviations, and OOS investigations-work with the team to find a root cause 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 SOP’s, 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 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 facilities contamination control strategy.

• B.S. degree in Biology/Microbiology with 8 years or MS with 4 years of relevant industry experience in a QC lab.
• Demonstrated experience of aseptic techniques and common microbiological testing.
• Supports/Mentors routine work, help/coach the team for testing or technical documents/projects
• Good documentation, data organization, detail oriented, and for 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 timely fashion.
• Strong interpersonal skills, highly collaborative within a multi-disciplinary team and contributes to a supportive and positive work environment
• This role is scheduled to work during day shift (8 am to 5 pm) on Monday to Friday and flexibility may be required to support GMP Operations.

• Prior experience in QC environment, knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industry.
• Model our core values- Be Bold, Care Deeply, getting stuff done- while promoting the team culture and Compliance.

• This role frequently requires long hours of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting to 35lbs.
• Requires gowning inside the cleanroom for extended periods of time.
• Use of gloves and mask is required to prevent exposure to biohazards and viruses.
• This is an on-site role working in a cGMP regulated manufacturing facility.

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

$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)