Job Requisition:Viral Diagnostics and Assay Development Manager
Leidos is seeking a Viral Diagnostics and Assay Development Manager who will direct testing and develop assays for viral products manufactured at a manufacturing facility in Silver Spring, MD. S/he will manage, oversee, and perform assays for the detection of viruses in various matrices, such as culture media, animal and human plasma/blood/serum, and other tissues.
This position is contingent upon contract award.
- Oversee a group of qualified technicians that are responsible for all aspects of testing for quality and safety of viral products that are required in the development process.
- Maintain a validated and calibrated laboratory that will generate data used for Investigational New Drug submissions to the FDA.
- Development of new assays including potency and safety assays for products intended for human use.
- Write and review standard operating procedures.
- Conduct testing, which may include assay of infectivity, protein and antigen content, potency, purity and other characterization assays required for complete analysis of final products or intermediates.
- Qualification or validation of assays dependent upon the level of regulatory scrutiny
- Participate in the generation of product testing summary reports and Certificates of Analyses.
- MS degree in biochemistry or related science and at least six years of experience in viral testing desired
- At least six years of experience in viral assay development and testing of viral products
- GLP and GMP experience.
- Must possess skills using various types of analytical and laboratory equipment, as well as proficiency with IBM compatible software including spreadsheet programs and word processing programs.
- Must also have four years of managerial/supervisory experience.
- All proposed personnel to perform services contractor must verify employment eligibility (E-Verify) and obtain a favorable National Agency Check (NACI).
External Referral Bonus:Ineligible
Potential for Telework:No
Clearance Level Required:NACI
Scheduled Weekly Hours:40
Job Family:Research Scientist2000Health
Leidos is a Fortune 500® information technology, engineering, and science solutions and services leader working to solve the world's toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company's 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported annual revenues of approximately $10.19 billion for the fiscal year ended December 28, 2018. For more information, visit www.Leidos.com.
Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here.
Leidos will never ask you to provide payment-related information at any part of the employment application process. And Leidos will communicate with you only through emails that are sent from a Leidos.com email address. If you receive an email purporting to be from Leidos that asks for payment-related information or any other personal information, please report the email to firstname.lastname@example.org.
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.