Leidos is seeking a Viral Products Lead who will lead the Viral Products Section at a manufacturing facility in Silver Spring, MD. The virologist is responsible for managing/leading the process development and manufacture of viral vaccines and other viral products for human use. Current vaccine projects include dengue, Japanese encephalitis, and HIV. Vaccine candidates may be whole virus-inactivated, live-attenuated, recombinant subunit or live-vectored immunogens.
This position is contingent upon contract award.
- Responsible for all viral vaccine candidate development and production. Research discoveries will be implemented for this process.
- Optimize growth of virus in cell cultures and scale these processes to the desired level of production.
- Operate bioprocess equipment under strict adherence to cGMP, OSHA and required policies and regulations.
- Recognizes and escalates bioprocess operational risks to team lead or Manager prior to failure, to ensure safety and compliance requirements.
- Recommends and executes projects and changes to bioprocess operations to reduce risk and increase efficiency.
- Performs in-process assays to monitor process performance.
- Responsible basic trouble-shooting of technical issues and other problems encountered within the manufacturing process. Write deviation incident reports as needed.
- Carry out the manufacturing review (as delegated) of the completed batch record logbooks in a timely manner per established targets.
- Collaborate with the QA group to fulfill quality management goals and ensure the highest quality manufacturing processes. Participates in QA training programs as required.
- Prepare master and production seeds.
- Develop any processes such as concentration and purification required for the desired product.
- Write Standard Operating Procedures (SOPs) and Batch Production Records for full GMP documentation of production.
- Direct the appropriate safety tests required for the product and provide documents for FDA submission.
- BS/MS in microbiology with at least 10 years of experience in virology and cell culture technology. Experience may substitute for formal education.
- Must also have four years of managerial/supervisory experience.
- Knowledge and implementation of Good Manufacturing Practices (GMP) and manufacture of vaccines are desirable
- Current documented training in GMP regulations, preferred
- Specific knowledge and experience in cell culture husbandry, virus seed preparation, and aseptic procedures.
- Experienced in the use of laboratory equipment including centrifuges, tangential flow filters, autoclaves, and other standard equipment.
- Knowledge and use of viral plaque assays, hemagglutination, ELISA, and other standard viral assays.
- All proposed personnel to perform services contractor must verify employment eligibility (E-Verify) and obtain a favorable National Agency Check (NACI).