Principal Scientist - Infectious Disease Research

PRINCIPAL SCIENTIST  - INFECTIOUS DISEASE RESEARCH

General Summary

The Principal Scientist functions as a study director and subject matter expert on commercial and government contracts and has oversight of the scientific elements to ensure successful completion and/or implementation in the area of emerging viral infectious diseases. A Principal Scientist will have experience in in vivo studies for evaluating vaccines and therapeutics and will be competent in the execution and monitoring of GLP regulations as applied to various projects as well as monitoring project work for timely completion, deliverable tracking, budget maintenance, and quality standards. This position analyzes, interprets and produces final study reports for our sponsors; provides instruction to other members of the project team; collaborates with other senior members of the staff on projects, and provides training to others. The Principal Scientist provides coverage for client-facing activities and communications.  The position works closely with assigned project team members and related management for studies. The Principal Scientist is fully trained in the position's key responsibilities as it applies to work areas and may require training on new processes as they arise. The Principal Scientist is the highest level of individual contributor and is knowledgeable of emerging trends and may contribute to and influence best practice within Infectious Disease Research. The position serves as technical lead for project proposals and may serve as Principal Investigator in government proposals.

Essential Duties & Responsibilities

• Performs role of Study Director (SD) and Scientific Subject Matter Expert (SME) on infectious disease projects.
• Develops in vivo and in vitro experimental study design for vaccines and therapeutics
• Acts as a key scientific resource and point of control for our clients.
• Directs and oversees in vivo and/or in vitro studies, 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 Business Development, Client Engagement and marketing, develops new service offerings according to market need
• Within defined policies and procedures, provides resolution to complex scientific problems within a specified program.
• Works closely with Study Coordinator and/or Project Manager as Technical SME on assigned projects and interfaces with client's scientific staff as appropriate.
• Oversees and serves as a technical advisor for lab operations to execute assay development and validation experiments.
• Drafts protocols, amendments, and departmental notifications for projects; formats documents for correct grammar, punctuation, consistency in format and style, and adherence to regulatory requirements and contract language.
• May create and maintain the study file (electronic) and/or study binders (hard copy).
• May create and maintain the ACUP and BPR as needed.
• Distributes study protocols, amendments, and departmental notifications; prepares/reviews data collection systems/forms as needed; schedules and conducts pre-study meetings.
• Identifies and incorporates exceptions to GLP conduct into GLP study protocols as applicable (e.g., systems/processes that are not validated).
• Submits protocols, study records, and applicable data/reports to QA for review; manages and coordinates completion of audit responses.
• Completes review of Standard Operating Procedures (SOP) associated with study conduct and incorporates appropriate language into the protocol when necessary to provide detail on procedures not included.
• Reviews contract for use in execution of studies and proactively notifies Study Director or Project Manager of any issues.
• 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 including 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.
• Conducts data analysis and prepares study reports
• Authors, updates, and/or reviews area-specific Standard Operating Procedures (SOP), ensuring that SOP reflect current practices.
• May be asked to serve as System Administrator, assist on validation teams, ad hoc committees, represent at internal meetings, or contact sponsors regarding study specific issues.

Requirements/Minimum Qualifications

• PhD in life sciences discipline plus at least 10 years' relevant experience or DVM plus at least 12 years' relevant experience
• At least 4 years of experience as Study Director on In Vivo studies in CROs or Pharmaceutical Company or Academic Institutions
• Proven track record of leading large commercial or government proposal generation and securement of funding.
• Has advanced the field of knowledge in his/her specialty with strong publication record and patents.  Work directly impacts the present or future of the organization in significant ways.
• Broad experience in infectious disease research with in vitro and in vivo models is a must.
• Prior experience with Immunogenicity and efficacy testing in Animal models such as mice, ferrets, hamsters, monkeys
• Presentation and statistical analysis of data
• 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.
• As a Federal contractor, Southern Research may be required to comply with a Federal COVID-19 vaccination mandate.  In that event, Southern Research will require that all newly hired employees show proof of full COVID vaccination or authorized exemption prior to their start date.

Work Environment & Conditions

This position is in a laboratory environment (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. 

Physical Demands

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.