Specialist II, QC Microbiology

locations: USA - PA - East Norriton

time type: Full time

posted on: Posted Yesterday

job requisition id: R-105259

A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Position Summary:

Resilience seeks a Specialist II, 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 Specialist II, 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 and reports to the Director of Microbiology Quality Control. The position will be in our East Norriton, PA facility.

Position Responsibilities:

Sample testing and analysis of Cell Therapy products using microbiological methods (rapid sterility, endotoxin detection, and mycoplasma detection by qPCR).
Participate in method qualification/validation activities, as necessary.
Assist and perform environmental monitoring activities including but not limited to routine and in process monitoring during productions, aseptic simulations, and environmental monitoring performance qualifications, as necessary.
Observe and growth promote environmental monitoring plates in addition to media generated from Aseptic Process Validations.
Analyze, document, and report experimental data in accordance with Resilience requirements.
Review of GMP experimental data.
Assist in compiling environmental monitoring data for review and discussion within Technical Operations team.
Assist in investigations as they relate to microbiological testing and/or environmental monitoring
Maintain, calibrate, and operate required equipment.
Maintain laboratory supplies.
Other activities as assigned.
Will require occasional early morning, late evening, and/or weekend work.

Minimum Qualifications:

Experience in microbiological testing
Basic understanding of cGMP requirements
Several years of relevant experience within a GMP environment

Preferred Qualifications:

Demonstrated knowledge / thorough understanding of microbiological methods and relevant regulatory guidelines
Strong planning and organizational skills
Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders
Excellent attention to detail
Proven record of cross-functional and matrix team leadership
Experience with LIMS and/or electronic environmental monitoring databases
Excellent interpersonal, verbal and written communication skills
Experience in application of lean methodologies and operational excellence principles

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $65,000.00 - $87,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

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Specialist II, QC Microbiology