Scientific Program Manager

We are seeking a Scientific Program Managerto support the National Institutes of Healths (NIH) world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda MD. Our NIAID professional technical and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with groundbreaking research. Candidates will work at a prominent and vibrant NIAID worksite to directly support exciting ongoing research activities as a contractor team member. Accelerate your career and apply below to help us make a difference.

CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through highquality costeffective programs and research management services. We combine our proven systems with todays most effective evidencebased best practices. Our core practice areas include: clinical research; vaccine research microbiology and infectious disease research development and production; biodefense; global health security; and HIV/AIDS programs.

Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS you will notably improve the lives of people at home and abroad.

The position is for 6 months.

• Apply expert scientific knowledge of the pharmaceutical product development process to guide VRC product portfolio management. This includes clarifying critical problems developing and implementing solutions resolving gaps in skills or capacity of the project management staff needed to accomplish the work assessing options and their impact on project costs quality of work products and timeliness of completion of tasks.
• Ensure that project plans are consistent with the longterm mission and available resources of the Office of Strategic Development (SPD) VRC and the VRC Office of the Director (OSD) and specify the responsible organizational component and staff to be assigned to each task and/or activity.
• Assist the Director of the Vaccine Production Program in the development and technology transfer of manufacturing processes formulations and analytical procedures to enable Good Manufacturing Practices (GMP) production of various vaccines antibodies and adjuvants.
• Oversee the Vaccine Clinical Materials Program (VCMP) in the GMP production of vaccines antibodies and adjuvants to meet VRC clinical trial objectives.
• Generate high producing cell lines and optimize their growth conditions to enable sufficient expression to meet program goals for clinical trial material.
• Develop robust downstream processes to ensure purity and potency of the clinical trial material is suitable for human use as well as provides sufficient viral clearance to meet regulatory requirements (as needed).
• Establish analytical assays including purity potency and identity assays to confirm the quality of material is suitable for human use and are sufficient to monitor the stability of the material.
• Support strategic initiatives of VRC leadership including establishment of project management resource tools to enable dissemination of project progress across the entire VRC portfolio.
• Establish and coordinate the flow of dependencies between project tasks and ensure that project plans are well organized and there are adequate tools to manage the project among the various functional and organizational components involved in the project.
• Monitor assess and communicate to VRC leadership project management staff interagency partners external collaborators and VRC project teams the status and progress of all projects within the VRC development portfolio issues/problems emerging scheduling conflicts or opportunities to accomplish the work.
• Use critical path analysis and/or comparable project management tools to track progress and make recommendations on prioritization of projects.
• Monitor deadlines and other benchmarks to ensure that VRC activities are meeting stipulated obligations.
• Apply situationally appropriate project management practices to guide research teams to successfully complete projects to keep activities on schedule and to facilitate an effective project that best meets VRC and NIAID goals.
• Originate formulate and disseminate project information assessments and evaluations to ensure that VRC leadership is properly apprised of progress and their views concerning project activities are properly disseminated in order to integrate project activities across the
  organization.
• Identify current or emerging issues affecting projects tasks/activities and/or the accomplishment of scientific objectives the sequencing of activities activity completion times.
• Generate a range of project planning options and relevant information to assist in the formulation of effective policies and procedures and ensure that each plan is a complete and accurate expression of all necessary tasks to accomplish the projects objectives.
• Provide expertise and guidance designing and conducting preclinical safety toxicology studies preclinical tissuecross reactivity studies and other INDenabling proof of concept research.
• Serve as a technical and scientific advisor to SPD Vaccine Production Program (VPP) and VRC OSD on the translational processes leading to the manufacture of a pharmaceutical product particularly as pertinent to biologics and vaccines and to coordinate the design and conduct of projects where the specifics of the project are difficult to determine in advance.
• Facilitate communication and resolution of conflicts among different organizational groups with varying interests or concerns that may conflict with project timetables scientific requirements availability of staff and/or staff time available resources and sequencing demands.
• Continuously collaborate with the VRC managers laboratory heads principal investigators and other personnel to identify devise implement and maintain improvements in the management of vaccine development and manufacturing projects.

• Masters degree in biological sciences is required.
• Minimum of fifteen (15) years of experience in project management working with small molecules therapeutic antibodies vaccines and other protein products in infectious diseases and biodefense is required.
• Experience with clinical trials.
• Experiencing analyzing assays including purity potency and quality.
• Experience producing cell lines.
• Strong organizational and time management skills.
• Strong communication skills.

Physical Requirements:

The physical requirements described here are representative of those that must be met by a candidate to perform the essential functions of this job. Reasonable accommodations may be provided to enable individuals with disabilities to perform essential job functions.

• Ability to lift or carry less than 25 pounds push or pull less than 25 pounds reach above shoulder level and use both hands.
• Required to stand or walk more than 25 of 30 minutes and to bend repeatedly and climb.
• Must have depth perception and correctable near vision. Must be able to distinguish basic colors and perform repetitive activities.
• Ability to work alone or closely with others.
• Requires working on ladders or scaffolding.
• Requires working with hands in water.
• Will be required to be in contact with lasers in instruments corrosive substances inorganic dust and powders heavy metals plastics solvents and sanitizing agents.
• Must be able to wear personal protective equipment (PPE) including gloves face shields/goggles safety glasses safety shoes lab coat and disposable dust/surgical mask.

Please submit your resume online at . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin age protected veteran status disability status or any other characteristic protected by any applicable federal state or local law.

CAMRIS offers a comprehensive benefits package including medical dental and vision insurance for individuals and families FSAs HSA life and AD&D insurance short and longterm disability legal services voluntary hospital indemnity critical illness and accident insurances EAP pet insurance 401(k) with employer match and Roth option tuition and professional reimbursement public transportation support in the DMV area a referral bonus program vacation with tenurebased increases PTO 11 paid holidays paid bonding leave and paid supplemental shortterm disability.

Employment is contingent upon successful completion of a Public Trustlevel background check a requirement for this position under an active federal contract. The background check process may include but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment education and credentials; (3) a criminal background check; (4) use/abuse of federallycontrolled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fullycomplete any required background check questionnaire during initial onboarding.