Senior Quality Affairs Subject Matter Expert

Summary

Join BryceTech as a BARDA Senior Quality Affairs Subject Matter Expert and contribute to the development of vaccines, therapeutics, diagnostics, and innovative technologies for public health emergencies. You will leverage your extensive experience in quality assurance and control within the pharmaceutical industry to advise BARDA leadership and staff. Responsibilities include providing subject matter expertise, training, and guidance on regulations and compliance. This remote position requires at least 15 years of relevant experience in senior quality assurance/control roles and a scientific degree. BryceTech offers a competitive salary and a comprehensive benefits package.

Requirements

• At least fifteen (15) years of relevant industry experience at senior quality assurance and /or quality control positions in the pharmaceutical industry
• Application of scientific degree in biology, chemistry, or pharmacy with commensurate experience

Responsibilities

• 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
• 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
• Provide subject matter expertise in quality assurance and control regulations in all GXPs supporting MCM development pathways
• Advise BARDA senior leadership on critical programmatic and project level quality issues
• Provide training and advisement to BARDA staff on regulations, compliance to government regulations, and interactions with quality and manufacturing contacts at contract facilities

Preferred Qualifications

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)

Benefits

• Competitive salary
• A comprehensive health plan including dental and vision coverage
• Company-paid life & disability insurance policies
• 401(k) plan with company match
• An educational reimbursement program
• This is remote position