Massachusetts Healthcare Jobs

QC Scientist I, 2nd Shift 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, 2nd Shift Microbiology opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

QC Scientist I, Microbiology (2nd Shift) will provide support to the AIRM MA-TC GMP Environmental Monitoring (EM) program, and microbial testing. QC Scientist I will be responsible for supporting review of EM and lab test results, technical writing, quality systems management and training. This role is scheduled for Monday to Friday second shift (12 pm to 8 pm) supporting GMP operations. This work schedule is subject to change to support business operations.

Essential Job Responsibilities:

• Responsible for EM, lab test results, and documents for product testing, EM, and trend reports.

• 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.

• Own Incident reports, deviation, Change Controls, CAPAs and OOS investigations-work with the team to find a root cause and implement corrective actions.

• Update laboratory procedures and help in data trending/summarization of the EM trend reports.

• Support cleanroom qualification, gowning qualification, aseptic process qualification, and personnel monitoring for manufacturing activities.

• Participate and own technical projects for QC process improvement and implementation.

• Represent QC in cross functional meetings and provide support/feedback for microbial quality/contamination control of the facility.

Quantitative Dimensions:

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

Organizational Context:

The QC Scientist I Microbiology will typically report to the Associate Director, 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.

Qualifications:

Required:

• B.S. degree in Biology/Microbiology with 8+ years or MS with 4+ years of relevant industry experience in a Quality Control 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 second shift (12 pm to 8 pm) on Monday to Friday and flexibility may be required to support GMP Operations. This work schedule is subject to change to support business operations.

• The ability to work weekends is required; while most of the schedule will be during a standard work week, there will be regular weekend work.

Preferred:

• Prior experience in QC environment, knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industry.

• Models our core values- Be Bold, Care Deeply, getting stuff done- while promoting the team culture and compliance.

Working Conditions:

• 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.

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

• 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

• Referral bonus program

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Category Massachusetts TC

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

EOE including Disability/Protected Veterans