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Company | Resilience |
Address | , East Norriton, Pa |
Employment type | FULL_TIME |
Salary | $85,000 - $111,250 a year |
Expires | 2023-07-16 |
Posted at | 11 months ago |
RESILIENCE (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.
For more information, visit
www.resilience.com
.Position Summary & Role:
Resilience seeks a Senior Specialist I, QC Microbiology, supporting the Microbiology department of QC. The successful candidate will aid in microbiological release testing of final product as well as performance of microbiological method development, feasibility, and qualification/validations of new matrices as well as corresponding data analysis and reporting.
The Senior Specialist I, QC Microbiology will partner and collaborate with Manufacturing, QC and analytical development operations, Project Management and external stakeholders to ensure streamlined and efficient operations of microbiological release testing and method development, meeting partner needs and complying with standard operating procedures.
This position is a first shift role, however will need to be flexible to support potential weekend work. The position will be in our East Norriton, PA facility.
Job Responsibilities
- Review / release of GMP experimental data.
- Will require occasional early morning, late evening, and/or weekend work.
- Analyze, document, and report experimental data in accordance with Resilience requirements.
- Other activities as assigned.
- Assist in compiling data for review and discussion within Technical Operations team.
- Sample testing and analysis of Cell Therapy products using microbiological methods (rapid ATP detection, endotoxin detection, and mycoplasma detection by qPCR).
- Maintain, calibrate, and operate required equipment.
- Participate in method qualification/validation activities, as necessary.
- Maintain laboratory supplies.
Minimum Qualifications:
- Basic understanding of cGMP requirements
- Experience in microbiological testing.
- Minimum bachelor’s degree in scientific discipline (i.e. Microbiology)
- 4+ years of relevant experience
- Demonstrated knowledge / thorough understanding of microbiological methods and relevant regulatory guidelines
Preferred Qualifications:
- Proven record of cross-functional and matrix team leadership
- Experience with NOVA-EM, LIMS and electronic environmental monitoring databases
- Excellent attention to detail
- Strong planning and organizational skills
- Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders
- Experience in application of lean methodologies and operational excellence principles
- Excellent interpersonal, verbal and written communication skills
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