Barda Jobs in Silver Spring, MD (NOW HIRING)

ProSidian is a Management and Operations Consulting Services Firm focusing on providing value to clients through tailored solutions based on industry leading practices. ProSidian services focus on the broad spectrum of Risk Management, Compliance, Business Process, IT Effectiveness, Energy & Sustainability, and Talent Management.  We help forward thinking clients solve problems and improve operations. 
Launched by former Big 4 Management Consultants; our multidisciplinary teams bring together the talents of nearly 190 professionals globally to complete a wide variety of engagements for Private Companies, Fortune 1,000 Enterprises, and Government Agencies of all sizes.  Our Services are deployed across the enterprise, target drivers of economic profit (growth, margin and efficiency), and are aligned at the intersections of assets, processes, policies and people delivering value. 
ProSidian clients represent a broad spectrum of industries to include but are not limited to Energy, Manufacturing, Chemical, Retail, Healthcare, Telecommunications, Hospitality, Pharmaceuticals, Banking & Financial Services, Transportation, Federal and State Government Agencies.  Learn More About ProSidian Consulting at www.ProSidian.com.

ProSidian Seeks a Senior Drug/Vaccine/Diagnostic/Clinical Development SME | Healthcare and Life Sciences [HHS116021] - 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. 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 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.

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

#TechnicalCrossCuttingJobs #Consulting #Nuclear #GovernmentSupportServices #ProfessionalAnalyticalSupport #Jugaad #Copitas #PokaYoke

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
• Communication - ability to effectively communicate to stakeholders of all levels orally and in writing
• Motivation - persistent in pursuit of quality and optimal client and company solutions
• Agility - ability to quickly understand and transition between different projects, concepts, initiatives, or work streams
• Judgment - exercises prudence and insight in decision-making process while mindful of other stakeholders and long-term ramifications
• Organization - ability to manage projects and activity, and prioritize tasks

------------ ------------ ------------

OTHER REQUIREMENTS

• Business Tools -  understanding and proficiency with business tools and technology, including Microsoft Office. The ideal candidate is advanced with Excel, Access, Outlook, PowerPoint and Word, and proficient with Adobe Acrobat, data analytic tools, and Visio with the ability to quickly learn other tools as necessary.
• Business Tools - understanding and proficiency with business tools and technology, including Microsoft Office. The ideal candidate is advanced with Excel, Access, Outlook, PowerPoint and Word, and proficient with Adobe Acrobat, data analytic tools, and Visio with the ability to quickly learn other tools as necessary.
• Commitment - to work with smart, interesting people with diverse backgrounds to solve the biggest challenges across private, public and social sectors
• Curiosity - the ideal candidate exhibits an inquisitive nature and the ability to question the status quo among a community of people they enjoy and teams that work well together
• Humility - exhibits grace in success and failure while doing meaningful work where skills have impact and make a difference
• Willingness - to constantly learn, share, and grow and to view the world as their classroom

------------ ------------ ------------

BENEFITS AND HIGHLIGHTS

ProSidian Employee Benefits and Highlights: Your good health and well-being are important to ProSidian Consulting. At ProSidian, we invest in our employees to help them stay healthy and achieve work-life balance. That's why we are also pleased to offer the Employee Benefits Program, designed to promote your health and personal welfare. Our growing list of benefits currently include the following for Full Time Employees:

• 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:P...