Scientific Program Manager (Regulatory Affairs & CMC Preparation) - NIH
Company: Kelly Services
Posted on: November 22, 2021
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 the leading medical research center in the world. We are
seeking an experienced individual to work as a Scientific Program
Manager - (Regulatory Affairs/Biologics and Vaccine CMC
Preparation) at the National Institutes of Health in Gaithersburg,
This is a long-term contract position which offers:
- Competitive compensation and comprehensive benefit package
- Optional health, vision, and dental plans
- Vacation leave as well as paid federal holidays and 401K
- Access to NIH's unparalleled resources and niche scientific
TASKS/SERVICES. The contractor shall:
(1) Responsible for chemistry, manufacturing and controls (CMC)
information of all investigational new drug (IND) applications for
vaccines, monoclonal antibodies, and related biological
(2) Assist regulatory program managers with CMC-relevant responses
to comments from regulatory authorities.
(3) Oversee planning, preparation and review of Module 3 sections
in Common Technical Document (CTD) format for submission to
(4) Ensure documentation follows FDA guidelines and Code of Federal
(5) Interact collaboratively with VRC Office of Regulatory Sciences
and Project Management groups.
(6) Serve as a subject matter expert for Vaccine Production Program
(VPP) process development staff for raw material sourcing and
product testing strategies.
(7) Interact with the VRC's pilot plant manufacturing, regulatory
and quality assurance staff.
(8) Review and provide comments, recommendations, and strategies on
product specifications, stability protocols, comparability
protocols and reports, investigator brochures and other related CMC
documents during product development of biological products for
early phase clinical trials.
REQUIREMENTS. The contractor must have:
(1) Bachelor's degree in biology, life science or related
discipline; master's degree preferred
(2) Minimum of 6 years of related experience with progressively
responsible experience in regulatory affairs.
(3) Minimum of 5 years working experience with biologics or
vaccines CMC preparation in the US.
(4) Direct experience assembling regulatory applications in eCTD
(5) Demonstrated strong understanding of the U.S. regulatory
(6) Excellent organizational and communication skills.
(7) Expertise in MS Office and SharePoint.
Please Note: Vaccination against COVID-19 is a requirement for all
job opportunities offered through Kelly Government Solutions, in
accordance with the Executive Order on Ensuring Adequate COVID
Safety Protocols for Federal Contractors.
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.
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
As a specialty talent company, Kelly is committed to doing the
right thing for our talent and clients. We stand up for equity,
inclusion, fair treatment, and opportunity for all as these build
the foundation of our Talent Promise. With a focus on safety,
value, well-being, investment, and opportunity, Kelly's Talent
Promise confirms our commitment to those in search of a better way
to work and live and to help discover what's next.
It is obvious things are different than they were just a few months
ago. Kelly is at the forefront of ensuring the safety of our
employees in this new working environment. Be well and stay
**Why Kelly** **--** **?**
Looking to connect with premier government agencies or the top 25
federal government contractors? Kelly-- Government offers a variety
of full-time, project (SOW), seasonal, and surge support
opportunities in science, engineering, technical, professional, and
administrative support roles. Our experts will find you the
opportunity that fits your schedule and interests and handle the
details of transferring and processing all levels of security
clearances. It's just another way we make the job search work for
**You should know:** Vaccination against COVID-19 is a requirement
for all job opportunities offered through Kelly Government
Solutions, in accordance with the Executive Order on Ensuring
Adequate COVID Safety Protocols for Federal Contractors.
**About Kelly** **--**
At Kelly, we're always thinking about what's next and advising job
seekers on new ways of working to reach their full potential. In
fact, we're a leading advocate for temporary/nontraditional
workstyles, because we believe they allow flexibility and
tremendous growth opportunities that enable a better way to work
and live (plus, did we mention we provide a ton of benefits ?).
Connecting great people with great companies is what we do best,
and our employment opportunities span a wide variety of workstyles,
skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a
diverse workforce, including, but not limited to, minorities,
females, individuals with disabilities, protected veterans, sexual
orientation, gender identity Equal Employment Opportunity is The
Keywords: Kelly Services, Washington DC , Scientific Program Manager (Regulatory Affairs & CMC Preparation) - NIH, Executive , Gaithersburg, DC
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