Senior Scientist – Infectious Disease Research
The Senior Scientist functions as a subject matter expert within the organization and has oversight of the scientific elements to ensure successful completion and/or implementation. This position analyzes and reports results for publication or to sponsor; provides instruction to other members of the project team; and collaborates with other senior members of the staff on projects/research. Highest level of individual contributor. Knowledgeable of emerging trends and may contribute to and influence best practice within discipline.
Essential Duties & Responsibilities
· Perform role of Study Director (SD) and Scientific Subject Matter Expert (SME) on commercial or large government contracts and grants.
· Directs in vivo and/or in vitro studies and oversees assay development/validation and other experiments conducted in Operations.
· Partners with Business Development, Project Management, and Proposals to ensure successful client engagement, proposal development, study execution, and deliverables upon study completion.
· In collaboration with the marketing support function in DDV, responsible for new pipeline development under IR&D funding.
· Within defined policies and procedures, provides resolution to complex scientific problems within a specified program.
· May serve as Pl on large government contract(s).
· Participates in all required Good Laboratory Practice (GLP) training.
· Works closely with Study Coordinator and/or Project Manager as Technical SME on assigned projects and will interface with client’s scientific staff as appropriate.
· May assume the role of SD or Principal Investigator (PI) on commercial and government contracts.
· Develops assays; completes study designs for infectious disease In Vitro and/or In Vivo studies.
· Oversees and serves as a technical advisor for lab operations to execute assay development and validation experiments.
· Writes study protocols and validation plans.
· Supports troubleshooting assay issues in validation and sample analysis.
· Participates in proposal generation and performs scientific/technical review.
· Follows GLP practices to ensure all experimental data, including observations of unanticipated responses are accurately recorded and verified.
· Ensures compliance to all regulatory and safety requirements for work with select agents.
· Observes appropriate safety and study requirements by reading, understanding, and following Standard Operating Procedures (SOP), GLP requirements, and study protocols.
· Accountable for some level of revenue generation.
· PhD in life sciences discipline plus at least 4 years’ relevant experience.
· Proven track record of leading large government or commercial proposal generation and securement of funding.
· Has advanced the field of knowledge in his/her specialty. Work directly impacts the present or future of the organization in significant ways.
· Proficient in assay development/qualification and directing/mentoring validation methodologies for clinical trial support in a GLP environment.
· Must demonstrate full competency under regulated environment (e.g. GLP, BSL-3/SA).
· Ability to work in A/BSL-1, 2, and 3 environments.
· Must be eligible to work in the U.S. without employer sponsorship.
Work Environment & Conditions
This position is in a laboratory environment (A/BSL 1, 2, & 3) and requires the use of personal protective equipment (PPE) including (but not limited to):
· Eye protection (Safety glasses and/or full face shield)
· Respirator (varies based on tasks and barrier requirements)
· Tyvek/scrub suits
· Nitrile (or equivalent) gloves (varies based on tasks)
· Hearing protection (varies based on tasks)
· Immunizations are required for this position and are determined by the study/agent. Some examples include Tetanus, Hepatitis B, Smallpox, Polio, and Influenza.
This position requires the following physical abilities including (but not limited to):
· Performing work with utilizing a computer for extended periods of time.
· Sitting for extended periods of time without being able to leave the work area.
· Standing for extended periods of time without being able to leave the work area.
Certifications, Licenses & Registrations
No certifications are required; however, training includes Good Laboratory Practices and annual training on safe handling of viruses. Radiation safety training may be required depending upon the assays utilized.