Scientific Technical Advisors

Leidos is seeking Scientific Technical Advisors contingent upon contract award to be performed hybrid onsite in Washington DC.

Candidate MUST:

Be a US Citizen or Green Card Holder with the ability to obtain a Public Trust Clearance

Be located w/in 50 miles of location for hybrid/onsite work.

Duties:

Provide expertise and advisory support related to medical countermeasures being utilized for federal public health emergency responses.

Provide advance services including but not limited to: Data cleaning Data transfers Data quality control Data integration and validation Data analysis and report package preparation Statistical simulation Statistical toolbox for advanced data modelling tabulation and visualization

In addition this position will provide ad hoc statistical support to BARDA projects under the guidance of BARDA statisticians.

Directs tasks and leads technical efforts and scientific projects. Acts as an SME on scientific subjects. Contributes subject matter expertise to programs with technical or program management expertise.

Provide advisory support to BARDA Program Division(s); Prepare draft work statements (SOW SOO PWS IGCE & Cost Estimates) for solicitations Request for Information (RFIs) Request for Proposals (RFPs) Sources Sought Notices (SSN) et al.

Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts technical proposals and budget proposals.

Participate on Program Coordination Teams (PCTs)

Provide assessments recommendations and guidance as well as educational material to PCT and COR as needed

Participate in strategic discussions working with USG in building new program areas in alignment with BARDAs mission space.

Provide recommendations for project development level portfolio management and oversight as required.

Provide recommendations or advise on development implement and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.

Analyze protocols study reports regulatory documents presentations proposals and related documents as needed.

Additional duties related to programmatic support for MCM maybe assigned.

Candidates must demonstrate experience in: the understanding of medicinal chemistry; preclinical development (animal models pharmacology toxicology); advanced clinical development (medical officers immunologists clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry manufacturing and controls); process development process scale-up and process optimization; device development and manufacturing reliability engineering Software Assay chemistry microbiology virology immunology. Plastic consumable design and manufacturing. Experience in manufacturing scalability and capacity expansion and sterile/aseptic technic sterile manufacturing/filling and sterile facilities (sterile gowning) Provide guidance and recommendations on key issues related to the area(s) identified above.

Minimum Requirements:

Bachelors degree (graduate preferred) appropriate life sciences field (immunology molecular biology biochemistry microbiology or similar) or Bachelors (with commensurate experience) of science in a physical science field (engineering physics computer science or similar) Or relevant industry experience (listed) in pharmaceutical industry regulatory affairs and/or quality assurance and /or quality control positions application of degree in biology chemistry or pharmacy with commensurate experience.

Or a bachelors degree in chemistry Engineering or Biology including five (5) years of direct experience in pharmaceutical facility architecture and application in commercial building construction or a degree in business with experience in pharmaceutical product development and Total Life Cycle Cost (TLCC) management. *Or equivalent*

Programmatic / Technical Advisor Qualifications:

Minimum of Five (5) years of relevant industry experience with Bachelor s degree Graduate (preferred) in biological and/or chemical sciences with relevant experience or post graduate degree(s) in medicine or pharmacy or with commensurate experience(s) bachelors degree in computer science Statistics or related fields Extensive knowledge and experience in clinical trials and epidemiological research including three (3) years of direct statistical programming experience with strong programming skills in SAS R and other statistical software.

Extensive knowledge of FDA/ICH guidelines and CDISC data standards preferred.

Waiver maybe issued by the government if the proposed candidate has a combination minimum of years of industry experience and/or degree in desired discipline ALONG with a minimum of one year (52 weeks) of direct experience supporting organizations related to Advanced Research and Development (ARD) and Medical Countermeasures (MCM).

PHHS

Come break things (in a good way). Then build them smarter.

Were the tech company everyone calls when things get weird. We dont wear capes (theyre a safety hazard) but we do solve high-stakes problems with code caffeine and a healthy disregard for how its always been done.

Original Posting:

Pay Range:

The Leidos pay range for this job level is a general guideline onlyand not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job education experience knowledge skills and abilities as well as internal equity alignment with market data applicable bargaining agreement (if any) or other law.