Scientist II

Scientist IIJob ID: req4436Employee Type: exempt full-timeDivision: Clinical Research ProgramFacility: Rockville: 9800 MedCtrDrLocation: 9800 Medical Center Dr, Rockville, MD 20850 USA The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases. Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.PROGRAM DESCRIPTION Within Leidos Biomedical Research Inc., the Clinical Research Directorate (CRD) provides project and operational management of initiatives in support of the National Center for Advancing Translational Sciences (NCATS). NCATS supported efforts include management of the Therapeutics Development Branch (TDB) drug development programs such as gene therapies and antiviral therapeutic candidates. NCATS stimulates drug discovery and development collaboration between NIH, Leidos, academic scientists, nonprofit organizations, and pharmaceutical and biotechnology companies.  KEY ROLES/RESPONSIBILITIES A PhD-level scientist with experience, expertise, and training to support the discovery and development of chemistry, manufacturing, and controls (CMC) for preclinical and clinical development including gene therapy, biologic, and small-molecule therapeutic candidates. The responsibilities will include evaluating process development, formulation development, analytical development, and regulatory compliance for preclinical and GMP phase production.  Responsibilities include but are not limited to: Support the Drug Discovery and Development (DDD) program initiatives using experience and technical expertise by contributing to project planning, monitoring subcontractor performance, and meeting expectations for operational performance Work closely with the DDD leadership and NIH team members to implement research and development practices, including developing overarching project plans with scope and timelines and setting expectations for operational performance Initiate and direct the development or technology transfer of manufacturing processes and analytical methods for production at non-GMP and GMP quality to support therapeutic development of DDD projects Ensure candidates meet key quality attributes throughout CMC development using data from external and internal sources including subcontractor provided testing and internal (FNL or NIH) laboratories Facilitate with minimal supervision the onboarding of new therapeutic candidates for CMC development by interacting with other FNL and NCATS scientists Serve as scientific/technical lead for evaluation of experiment design and data analysis Support the quality management of manufacturing in non-GMP and GMP phases of development including analytical method transfer, development, or qualification; review of manufacturing documentation for compliance; review of quality control testing results to confirm product meets specifications Review and recommend for approval technical reports, SOPs, project specific protocols and reports Prepare manuscripts and scientific presentations Analyze data and presents findings at meetings Anticipate obstacles and implements solutions Perform review of project-specific documents Ensure appropriate communication strategies and plans are in place to facilitate and maintain communication among scientific, regulatory, safety, monitoring, laboratory, and project team members Position may travel occasionally domestically and internationally for annual scientific conferences BASIC QUALIFICATIONS To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below: Possession of a PhD degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA). Foreign degrees must be evaluated for equivalency In addition to the education requirement, a minimum of two (2) years of progressively responsible experienceDemonstrated experience leading CMC development across phases, including gene therapy and vaccine programs approved by FDA/EMAExpertise in managing CDMOs, regulatory submissions, GMP operations, and end-to-end drug product developmentProven strengths in planning, risk mitigation, and problem-solving, including structured methodologies and process improvementFamiliarity with regulatory expectations and federal compliance, including technology transfer activities under GMP and non-GMP frameworksExcellent communication skills demonstrated through preparation of regulatory filings, technical reports, cross-functional presentations, and leadership updatesStrong organizational skills with the ability to prioritize and manage multiple tasks with a high degree of accuracy and attention to detailAbility to work effectively, both independently and as a team member, with consistent ability to take initiative and make an active contribution to the team's performanceDemonstrated proficiency in Windows and Microsoft Office Suite including Word, Excel, Project, and OutlookAbility to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Candidates with these desired skills will be given preferential consideration: Extensive experience in end-to-end pharmaceutical development for gene therapies, vaccines, nanoparticles, and parenteral drug products Advanced experience leading CMC projects, managing CDMO’s and external manufacturers, and supporting both early and late-stage development activities Experience conducting federally funded research studies Knowledge of Microsoft Office, Microsoft Project, and other software applications to execute the needs of the project Commitment to Non-DiscriminationAll qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws. Pay and Benefits Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available 103, - 147, USDThe posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data. The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions