Technical Advisors - Various Capabilities in Pharma & Biotech at Tunnell Government Services

Bethesda, Maryland, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Jan, 26

Salary

0.0

Posted On

08 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medicinal Chemistry, Preclinical Development, Clinical Development, Analytical Testing, Quality Control, Regulatory Policy, Manufacturing, Process Development, Statistical Programming, Clinical Trials, Epidemiological Research, FDA Guidelines, CDISC Standards, Microbiology, Immunology, Data Analysis

Industry

Pharmaceutical Manufacturing

Description

Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us. Applicants must be US based with US working authorization Positions – Multiple Technical Advisors needed to support Critical Operations, Research & Expertise (CORE) Scientific & Programmatic Assistance Services in the various areas of interest within the Medical Countermeasures field of Research and Development (R&D)/Analytical Research and Development (AR&D) of biotechnology and biopharmaceuticals supporting BARDA. These services are critical in support of BARDA’s mission to conduct R&D and AR&D efforts to provide medical countermeasures that address the public health medical consequences of chemical, biological, radiological, and nuclear (CBRN) events, pandemic influenza, and emerging infectious diseases. Responsibilities: 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. Direct tasks and lead technical efforts and scientific projects. Act as an SME on scientific subjects. Contribute subject matter expertise to programs with technical or program management expertise. Facilitates meetings as directed. 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 BARDA’s 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 may be assigned. Requirements/Qualifications: 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 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) bachelor's 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. Or Bachelor's 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 Bachelor's 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. Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.

Responsibilities

Provide expertise and advisory support related to medical countermeasures for federal public health emergency responses. Lead technical efforts and scientific projects while contributing subject matter expertise to programs.