Senior Chemical SME | Healthcare and Life Sciences [HHS112017]

ProSidian Consulting•Washington, DC

13d

About The Position

ProSidian Seeks a Senior Chemical SME | Healthcare and Life Sciences [HHS112017] - DPLH Est.: 1912 Hrs. ST | 0 Hrs. OT on a Exempt Full-Time Basis Mid Atlantic | ProSidian Labor Category - Senior Consultant 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. 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.. Seeking Senior Chemical 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 Chemical 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).

Requirements

Minimum of 15 years of relevant experience in chemical threats, pharmacology, or toxicology.
Proven track record in developing and managing advanced development and acquisition programs for chemical threat medical countermeasures.
Doctoral degree in Chemistry, Pharmacology, Toxicology, or similar fields.
EC118 Equivalent commensurate experience in related scientific disciplines is acceptable.
Expertise in preclinical development (animal models, pharmacology, toxicology) and advanced clinical development.
Proficiency in regulatory policy, process optimization, scale-up manufacturing, and chemistry, manufacturing, and controls (CMC).
Experience with Total Life Cycle Cost (TLCC) management, market research, and cost estimation.
Ability to prepare expert summary reports, technical evaluations, and risk/benefit analyses tailored to BARDA’s mission
Strong advisory capabilities for federal staff on project management and portfolio alignment with BARDA’s strategic objectives.
Effective communication and summarization skills for technical evaluations, enabling informed decision-making.
Leadership in technical evaluation panels, program coordination teams, and collaborative discussions with federal leadership

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.
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.

Benefits

Competitive Compensation: Pay range begins in the competitive ranges with Group Health Benefits, Pre-tax Employee Benefits, and Performance Incentives.
For medical and dental benefits, the Company contributes a fixed dollar amount each month towards the plan you elect. Contributions are deducted on a Pre-tax basis.
Group Medical Health Insurance Benefits: ProSidian partners with BC/BS, to offer a range of medical plans, including high-deductible health plans or PPOs.
Group Dental Health Insurance Benefits: ProSidian dental carriers - Delta, Aetna, Guardian, and MetLife.
Group Vision Health Insurance Benefits: ProSidian offers high/low vision plans through 2 carriers: Aetna and VSP.
401(k) Retirement Savings Plan: 401(k) Retirement Savings Plans help you save for your retirement for eligible employees. A range of investment options are available with a personal financial planner to assist you. The Plan is a pre-tax Safe Harbor 401(k) Retirement Savings Plan with a company match.
Vacation and Paid Time-Off (PTO) Benefits: Eligible employees use PTO for vacation, a doctor’s appointment, or any number of events in your life. Currently these benefits include Vacation/Sick days – 2 weeks/3 days | Holidays - 10 ProSidian and Government Days are given.
Pre-Tax Payment Programs: Pre-Tax Payment Programs currently exist in the form of a Premium Only Plan (POP). These Plans offer a full Flexible Spending Account (FSA) Plan and a tax benefit for eligible employees.
Purchasing Discounts & Savings Plans: We want you to achieve financial success. We offer a Purchasing Discounts & Savings Plan through The Corporate Perks Benefit Program. This provides special discounts for eligible employees on products and services you buy on a daily basis.
Security Clearance: Due to the nature of our consulting engagements there are Security Clearance requirements for Engagement Teams handling sensitive Engagements in the Federal Marketplace. A Security Clearance is a valued asset in your professional portfolio and adds to your credentials.
ProSidian Employee & Contractor Referral Bonus Program: ProSidian Consulting will pay up to 5k for all referrals employed for 90 days for candidates submitted through our Referral Program.
Performance Incentives: Due to the nature of our consulting engagements there are performance incentives associated with each new client that each employee works to pursue and support.
Flexible Spending Account: FSAs help you pay for eligible out-of-pocket health care and dependent day care expenses on a pre-tax basis. You determine your projected expenses for the Plan Year and then elect to set aside a portion of each paycheck into your FSA.
Supplemental Life/Accidental Death and Dismemberment Insurance: If you want extra protection for yourself and your eligible dependents, you have the option to elect supplemental life insurance. D&D covers death or dismemberment from an accident only.
Short- and Long-Term Disability Insurance: Disability insurance plans are designed to provide income protection while you recover from a disability.