Senior Scientific Program Manager

Location
Bethesda, MD, United States
Posted
Apr 12, 2021
Ref
2021-10039
Hotbed
BioCapital
Required Education
Doctorate/PHD/MD
Position Type
Full time
Overview

We are currently searching for a Senior Scientific Program Manager to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Bethesda, MD.

Duties & Responsibilities

  • Basic research to clinical evaluation and towards potential licensure by providing all aspects of oversight and programmatic assistance to support teaching, training, and in vivo research for program laboratories.
  • Represent the department in various departmental and interdepartmental committees that address scientific and administrative
  • Plan, manage, and analyze data from animal and clinical studies evaluating immunogenicity of vaccine candidates entering product
  • Develop assays to support development and/or QC testing as needed to support Analytical program.
  • Perform a wide range of complex procedures and techniques (may include, but are not limited to; cell culture, clinical/diagnostic microbiology, DNA analysis, DNA isolation, DNA purification, DNA sequencing, flow cytometry, gene cloning, immunohistochemistry, manipulation of radioactive isotopes, natural product isolation, organic synthesis, peptide synthesis, protein analysis, protein purification, )
  • Analyze unique problems involved with regulatory requirements and related scientific analysis.
  • Interact and collaborate with scientists from other organizations or institutions involved in similar or related research
  • Interact with and coach students, post-doctoral fellows and non-doctoral research technicians on experimental design and laboratory-based
  • Design experimental approaches provide critical evaluation of scientific data, integrates and starts up of new technologies within the
  • Direct special project activities with particular emphasis on coordinated research efforts among NIH and private, non-governmental
  • Facilitate collaborative efforts with stakeholders, HHS, Centers for Disease control and Prevention (CDC), Food and Drug Administration (FDA), academic institutions and private organizations and industries dedicated to expanding the state of knowledge of vaccine health, globally, so as to enhance research and clinical readiness, and promote synergy.
  • Provide guidance to senior management officials regarding unusual and novel issues relating to broad policy matters and the potential impact on the program mission and strategic objectives for the intramural
  • Apply strategic and scientific expertise to oversee integrated pre-clinical development plans for vaccines against HIV, HCV, HPIVs, HCMV, malaria,
  • Formulate policies, standards, procedures, and guidelines and ensures dissemination to laboratory staffs for
  • Review and assess science policy regulations and guidelines relating to
  • Develop implementing policies and provides leadership and the necessary oversight to ensure the following:
  • Quality assurance of products and/or services produced by the Center,
  • Compliance of Center-wide program execution with HHS and NIH policies and regulatory guidance,
  • Allocation of financial resources to the Center's consistent workload and the efficient use of personnel,
  • Scientific/technical review processes are established within the
  • Develop stable formulations for vaccine products, including (but not limited to) antibodies, virus-like particles and recombinant proteins. Oversee multiple development projects, primarily (but not limited to) early phase.
  • Support formulation/fill/finish technical transfer to Vaccine Clinical Materials
  • Collaborate effectively with other groups, including Cell Line, Cell Culture, Purification, Analytical, Quality Control, Regulatory, Clinical, and
  • Design immunizations regimens for vaccine study in mice, guinea pigs and non-human
  • Write reports of findings, stating methods and procedures, including any modifications employed specimens and materials involved, and results of
  • Perform comparability assessments of bioanalytical
  • Development of functional nanobody as diagnostic and therapeutic reagents against infectious pathogens, such as SARS-CoV2, HIV,
  • Conduct structural-functional analysis of pathogen-host interaction. Utilize X-ray crystallographic and electron microscopic methods to determine structures of proteins from infectious
  • Lead vaccine project team, coordinate intramural and extramural collaboration. Present critical scientific result to facilitate decision making by program
  • Write and publish peer-review scientific papers on the research projects conducted.
  • Provides leadership and coordination the Electron Microscopic analysis of pathogen-antibody interaction and immunogen-antibody recognition, as an ongoing platform to support vaccine design and
  • Provide leadership and coordination for the malaria RIFIN
  • Provide leadership and coordination for the nano-mouse vaccination studies, which are part of an ongoing collaborative effort with Casellas group to develop antibody-related therapeutics against target pathogens such as
  • Create new research protocols.


Requirements

  • Ph.D. in a Scientific discipline
  • Minimum of five (5) years of experience in a science-related field.
  • Demonstrated expert knowledge working in the research laboratory.
  • Experience in vaccine and therapeutic development research, rodents, and nonhuman primates; familiarity with principles of Good Laboratory Practices (GLP) animal studies and regulatory compliance; and a record of independent research with authorship in peer-reviewed publications.
  • Experience with protein blotting techniques such as dot/slot and western blots; agarose andacrylamide gel electrophoresis procedures; high-throughput epitope-screening and characterization assays such as Octet biolayer interferometry; flow cytometry techniques and analysis techniques; immunological assays such as neutralization and ELISA assays.
  • Experience with tissue culture procedures such as culture of immortalized cell lines, and preparation of tissue culture reagents; culture of primary lymphocyte and cell lines.
  • Expertise on structure-based analysis of viral entry, antibody neutralization mechanism.
  • Expertise on structure-based vaccine design and antibody efficacy improvement.

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Company Description

We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.

The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth.

What you'll get...
  • Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
  • Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
  • Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
  • Discovery! With our tuition assistance and training programs, we support your career advancement.
  • Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
  • Support! Working parents and busy professionals - we've got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
  • Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
  • A Voice! A unique culture where you can influence decisions and have your voice heard.


We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.