QC Scientist I, Microbiology

 

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 heath 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 QC Scientist I, Microbiology opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

 

Purpose:

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.

 

Essential Job Responsibilities:

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.

 

Quantitative Dimensions:

The QC Scientist, Microbiology routinely interacts with Manufacturing, QC Analytical, Quality Assurance, and management for microbiological testing and special projects.

 

Organizational Context:

The QC Scientist Microbiology reports to the Manager, QC Microbiology.  This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas organization.