Senior Analyst I, Quality Control

General Company Description

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

The Senior Analyst I, Quality Control, will be responsible for method development, transfer qualification, validation, and performing variousin vitroassays to support drugs and clinical product development. These products will include recombinant vaccines, viral-based vaccines, antibodies, and other therapeutic biopharmaceuticals. This position requires working with cross-functional teams.

Job Responsibilities

Tasks include, but are not limited to:

• Working in QC GLP and/or cGMP BSL-2 (and BSL 3) laboratory facilities and operations.
• Timely development and qualification of viral and other in vitro assays
• Transfer test protocols from the Analytical development lab (or clients) to the cGMP-compliant QC laboratory​.
• Perform QC release and in-process tests on many samples.
• Perform QC tests in support of Viral banking.
• Prepare and review virology SOPs, protocols, and reports.
• Routine operation and management of BSL2 (and BSL3) labs.
• Participate in other activities such as testing deviations, non-conformances, Out of Specification (OOS) failure investigations, etc.

*All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.

Preferred Experience, Education & Qualifications

• Bachelor’s degree in Biological Sciences, Virology, Microbiology, Biotechnology, or a related field. Advanced degree preferred.
• Knowledge and experience of cGMP and GLP.
• Experience working with mammalian cells, bacteria, live viruses, and viral-based vaccines (different infectivity assays, plaque assays, TCID50, neutralization assays, etc.).
• Experience writing and reviewing test methods, SOPs, protocols, and reports.
• Experience with viral disinfection efficacy studies is a plus.
• Capable of working independently with minimal supervision.
• Willing to work in a teamwork environment where individual collaboration and accountability are valued.

Minimum Qualifications

• Experience in basic molecular biology (RNA/DNA/plasmid extraction, qPCR, and Droplet Digital PCR).
• Six (6) years of related experience in a regulated laboratory environment.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential function of this job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is occasionally required to

• Stoop, crouch, reach, walk, pull, push, stand, lift, do repetitive motions, grasping, and talking.Sitting long hours performing assays working in biosafety cabinets
• Exposure to the following hazards: Electrical current, moving mechanical parts, exposure to chemicals, packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 2 and 3, including for emergency response. Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.
• Occasionally be required to perform sedentary, light, medium, heavy, and very heavy work (Exerting in excess of 100 pounds of force occasionally, and/or in excess of 50 pounds of force frequently, and/or in excess of 20 pounds of force constantly to move objects).
• Preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; working under microscopes for continuous hours.
• On several occasions task may also require use of full face or half face respiratory protection like, Personal Air Purifying Respirators (PAPR)

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EOE STATEMENT

National Resilience Inc. is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, or military/veteran status or any other characteristics protected by law. EEO Minorities/Women/Disabled/Veterans

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 annualized base pay hiring range for this position is $69,000.00 - $87,000.00. 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.