Scientific Program Manager

Kelly; Washington; On-site; USD 70,000 - 115,000; Full time

Job summary

A leading company seeks a Scientific Program Manager for a long-term contract with the National Institutes of Health. This role involves overseeing clinical trials, managing quality assurance tasks, and coordinating between cross-functional teams in the immunology sector. Ideal candidates will have extensive experience in assay development and project management within the pharmaceutical industry.

Benefits

Competitive compensation

Comprehensive benefits package

Paid leave and federal holidays

401(k) plan

Optional health, vision, and dental plans

Qualifications

• Minimum 8 years of experience in pharmaceutical or related industry.
• At least 10 years of experience in R&D and immunological assays.
• Experience with regulatory requirements such as GLP/FDA practices.

Responsibilities

• Develop and maintain clinical trial testing master schedule.
• Manage QA tasks, prepare for audits, and guide study documentation.
• Serve as the Vaccine Immunology Program’s information coordinator.

Skills

Immunological assay development

Scientific project management

Protein analysis

Education

Master’s degree in Biology or Immunology

Job description

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This range is provided by Kelly. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$70,000.00/yr - $115,000.00/yr

Direct message the job poster from Kelly

Scientific Recruiter | PMP | Government Contracting

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Scientific Program Manager with the National Institutes of Health in Rockville, MD

This is a long-term contract position which offers:

• Competitive compensation and comprehensive benefit package
• Optional health, vision, and dental plans
• Paid leave (min 120 hours; prorated for part-time position) as well as 11 paid federal holidays and 401K plan.
• Access to NIH’s unparalleled resources and niche scientific initiatives. Ø Learn more about what Kelly can do for you at https://government.kellyservices.us/

TASKS. The contractor shall:

• Develop and maintain the clinical trial testing master schedule, track assay development activities, assign testing pipelines, and ensure availability of reagents and materials in coordination with the Testing Facility Manager and Federal Task Leader.
• Assist in performing GCLP-compliant quality assurance tasks, maintain master document inventories and archives, support CAPA tracking, prepare for audits and inspections, and guide study close-out documentation.
• Review and compile clinical study documentation; maintain digital and physical records in alignment with record retention policies; support completeness and compliance of clinical study plans.
• Serve as the Vaccine Immunology Program’s information coordinator, facilitate meetings, disseminate project updates and action items, and resolve conflicts among cross-functional team members with varying priorities.
• Author "Analytical Plans" outlining clinical testing requirements; represent the program in high-level clinical trial meetings and external collaborations; serve as SME for immunogenicity, antigenicity, and anti-drug antibody methodologies.
• Coordinate GCLP-compliant training programs and materials; ensure staff readiness for study-specific procedures; support onboarding and compliance monitoring.
• Assist in developing, validating, and transferring immunoassays and analytical methods to external labs or CROs; contribute expertise in reagent needs and biologics assay design.
• Identify gaps in existing processes, anticipate project risks or programmatic needs, and recommend innovative solutions for improving efficiency and meeting VRC objectives.
• Monitor timelines, benchmarks, and milestones; disseminate status reports; document meeting outcomes and support stakeholders in addressing issues and ensuring timely completion of tasks.
• Apply expert knowledge of assay development and biologics testing to guide meetings, clarify technical challenges, propose strategic solutions, and align project execution with the Vaccine Research Center’s broader mission.

REQUIREMENTS. The contractor must have:

• • Master’s degree in Biology or Immunology is required.
• • Minimum of 8 years of experience in the pharmaceutical, vaccine, biologics, or similar industry is required.
• • At least 10 years of experience in R&D, immunological assay development, is required.
• • Experience concerning Phase I/II/III method development for clinical trials is preferred.
• • Must have experience managing both scientific and organizational information. At least two years’ experience is required in coordination, planning or cross-functional position, project management experience is preferred.
• • Minimum 2 years’ experience in managing scientific and organizational organization
• • Experience in analysis of protein expression and proteomics characterization, and with Mesoscale Discovery (MSD) and Singulex methodology. Anti-drug antibody methodology also required.
• • Understanding of protein analysis with experience in quantitative and qualitative protein analysis for existing and novel assay development.
• • Knowledge of the requirements and experience developing, qualifying and/or validating assays for products and managing method transfers between laboratories.
• • Experience with vaccine / therapeutic protein development and regulatory requirements such as GLP/FDA practices.

PLEASE APPLY ONLINE

When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position; a full job description can be made available at that time.

Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you aren’t contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, short-term disability, and a transportation spending account. Visit https://www.mykelly.us/us-mykelly/perks/ for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Research, Science, and Administrative

• Industries

  Government Administration, Biotechnology Research, and Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Disability insurance

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