- Execute viral infectivity, viral antigen, and viral microneutralization assays according to standard operating procedures (SOPs).
- Quantify viruses using plaque assays using the aseptic technique within a BSC.
- Prepare cell cultures for virus inoculation and prepare viral seeds.
- Initiate and complete viral detection assays independently.
- Author and review method development and experimental reports for work performed.
- Independently perform cell and viral expansion.
- Develop and lead method verification, qualification, and validation activities.
- Author and review SOPs for quality control (QC) laboratory procedures.
- Develop detection and neutralization assays for novelty viruses.
- Support the QC group as directed by the head of Quality Control.
- Participate as ASAT lead in multiple projects concurrently.
- Assist in non-viral analytical transfer, method development, and assay qualification.
- Review and contribute to technology transfer and experimental plan documents, design experiments, perform material procurement market research, and generate transfer reports.
- Review and contribute to process descriptions, process deep dives, and technology transfer initiatives as assigned.
- Generate and review analytical results and supporting documentation to ensure quality standards are met for release and stability testing of starting materials, drug substances, and drug products.
- Analyze lab results, determine the success or failure of assays, and determine the next steps required.
- Develop, coordinate, plan, and execute development and cGMP testing at PBF as required.
- Generate and pre-review various assay data designated for clinical trials.
- Perform IQ/OQ/PQ and maintain lab equipment.
- Maintains a safe workplace, ensuring that they know and observe appropriate safety and occupational health rules and regulations. The employee must attend safety training relative to their position and report any infractions of safety procedures to the facility Safety Officer.
- Performs other related duties as required and assigned.
- Support lab resource management, including monitoring, directing, and managing lab activities and technicians as needed.
- A doctoral degree in biology or a related field and eight years of relevant experience or an equivalent combination of education and experience.
- Four or more years of experience in cell culture and virology research.
- Required Knowledge, Skills, and Abilities: Knowledge of applicable highly complex scientific procedures and techniques relating to the position.
- Must be knowledgeable in the use of laboratory equipment, including centrifuges, pH meters, spectrophotometers, microplate washers, incubators, and purification columns.
- Good Manufacturing Practices experience.
- Must possess general knowledge of virology, cell culture laboratories, cell culture husbandry, and aseptic techniques.
- Must be eligible to work in the United States and have lived in the United States for three of the past five years if a non-US citizen.
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ASAT Viral Senior Scientist - Silver Spring, United States - CAMRIS
Description
We are seeking an Analytical Sciences and Technology (ASAT) Viral Senior Scientist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaged in next-generation development for cutting-edge companies and government agencies. The professionals at PBF engage in trailblazing endeavors every day. Most exciting, the end products vary, so every year brings multiple opportunities for professional enrichment in original projects.
CAMRIS International, LLC, is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs.
Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.
Responsibilities
Qualifications
CAMRIS International LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.
Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.
Employment is contingent upon the successful completion of a background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to, the following: (1) contacting your professional references; (2) verification of previous employment, education, and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully complete any required background check questionnaire during initial onboarding.
