Senior Drug/Vaccine/Diagnostic/Clinical Development SME | Healthcare and Life Sciences

Senior Drug/Vaccine/Diagnostic/Clinical Development SME | Healthcare and Life Sciences

ProSidian Seeks a Senior Drug/Vaccine/Diagnostic/Clinical Development SME | Healthcare and Life Sciences - DPLH Est.: 1912 Hrs. ST | 0 Hrs. OT on a Exempt Full-Time Basis Mid Atlantic | ProSidian Labor Category - Subject Matter Expert Mid Level Professional aligned under services related to NAICS: 541611 - DPLH Est.: 1912 Hrs. ST | 0 Hrs. OT on a Exempt Full-Time Basis located CONUS - Washington DC Across The Mid Atlantic Region supporting Advanced Scientific Professional Staffing Support 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.

Seeking Senior Drug/Vaccine/Diagnostic/Clinical Development SME candidates with relevant Healthcare And Life Sciences Sector Experience (functional and technical area expertise also ideal) to support professional services engagement for Healthcare And Life Sciences Sector Clients such as HHS. This as a Full-Time ProSidian W-2 Healthcare and Life Sciences Functional Area - Healthcare And Life Sciences Supply/Service Initiative and an employed position with commensurate benefits and competitive salary.

JOB OVERVIEW

Provide services and support as a Healthcare And Life Sciences (Senior Drug/Vaccine/Diagnostic/Clinical Development SME) in the Healthcare And Life Sciences Industry Sector focusing on Human Capital Solutions for clients such as Department of Health and Human Services (HHS - ASPR | BARDA) | HHS Administration for Strategic Preparedness and Response (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA) Generally Located In CONUS - Washington DC and across the Mid Atlantic Region (Of Country/World).

RESPONSIBILITIES AND DUTIES - Senior Drug/Vaccine/Diagnostic/Clinical Development SME | Healthcare and Life Sciences [HHS116021]

• Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.
• Candidates with experience in the following areas are desired: 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.
• Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.
• Participate as subject matter experts on Program Coordination Teams (PCTs)
• Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed
• Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work
• Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.
• Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA's mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise.
• Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work Make suggestions on ways to improve those statements of work.
• Experience distilling complex information into informative and concise summaries, including providing risk/benefit analyses and balanced recommendations.
• Participate and aid 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.

Qualifications

Desired Qualifications For Senior Drug/Vaccine/Diagnostic/Clinical Development SME | Healthcare and Life Sciences [HHS116021] (HHS116021) Candidates:

• At least 10 years of biologics development and/or manufacturing experience in the biopharmaceutical industry.
• Senior Drug/Vaccine/Diagnostic/Clinical Development SME: At least 15 years of biologics development and/or manufacturing experience.
• Experience in CMC biologics product development from pre-clinical through full-scale production

Education / Experience Requirements / Qualifications

• Ph.D. in Pharmaceutical Sciences, Biochemistry, Virology, Microbiology, Chemistry, Engineering, or equivalent discipline preferred; or B.S./M.S. in biological sciences, chemistry, engineering, or related discipline with sufficient biopharmaceutical product development and manufacturing experience.
• 15 years of industry experience.

Skills Required

• Hands-on experience with CMC biologics product development.
• Expertise in drug formulation, manufacturing, process development, and troubleshooting technical issues related to quality, regulatory, and manufacturing.
• Knowledgeable in cleaning validation, analytical methods, technology transfer, and process validation.
• Experience in preparing CMC sections of INDs and BLAs.
• Ability to audit biologic drug product manufacturing facilities

Competencies Required

• Strong technical knowledge of biologics development from preclinical to commercialization.
• Excellent problem-solving skills to resolve issues related to quality, regulatory, and process development.
• Ability to articulate technical challenges and solutions in drug formulation and manufacturing.
• Proficiency in analytical and manufacturing technology transfer.
• Ability to communicate effectively in matrix and team-based environments

Ancillary Details Of The Roles

• Ability to travel up to 10% of the full-time schedule.
• Experience working in a matrix, team-oriented environment, particularly in CMC leadership roles.
• Prior experience in managing and advising on large-scale biologics manufacturing projects.
• Experience in regulatory affairs, including preparing and submitting CMC sections of INDs and BLAs to the FDA.
• Strong verbal and written communication skills
• Knowledgeable in late-stage CMC regulatory requirements and how they relate to commercialization.
• Involvement in identifying and resolving technical problems in manufacturing processes.
• Expertise in drug substance and drug product quality assessment, including specification development and validation methodology.
• Ability to work collaboratively with cross-functional teams to address technical, regulatory, and manufacturing challenges.

Other Details

• Expertise in biologics, diagnostics, vaccines, and other clinical development within the context of chemical, biological, radiological, and nuclear threats is essential.
• Ability to distill complex technical information into actionable insights for program management.
• Must be adept at advising federal teams on cost estimates, budget proposals, and recommendations for Total Life Cycle Cost (TLCC) management.
• Involvement in strategic discussions on the development of medical countermeasures for emerging infectious diseases and bioterrorism threats

Additional Information

CORE COMPETENCIES

• Teamwork – ability to foster teamwork collaboratively as a participant, and effectively as a team leader
• Leadership – ability to guide and lead colleagues on projects and initiatives
• Business Acumen – understanding and insight into how organizations perform, including business processes, data, systems, and people