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14 days old

Senior Scientist (Formulation & Analytical Development) - NIH - Gaithersburg

Kelly Services
Gaithersburg, MD 20898
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 Senior Scientist with Vaccine Formulation and Analytical Development experience to work onsite with the National Institutes of Health in Gaithersburg, MD.





This is a long-term contract position which offers:



- Competitive salary with comprehensive benefit package



- Opportunity to work at NIH, the world's foremost medical research center



- Learn more about what Kelly can do for you at www.kellygovernmentsolutions.com





TASKS: The contractor shall:




+ Responsible for chemistry, manufacturing and controls (CMC) information of all investigational new drug (IND) applications for vaccines, monoclonal antibodies, and related biological products.

+ Assist regulatory program managers with CMC-relevant responses to comments from regulatory authorities.

+ Oversee planning, preparation and review of Module 3 sections in Common Technical Document (CTD) format for submission to regulatory authorities.

+ Ensure documentation follows FDA guidelines and Code of Federal Regulations (CFR).

+ Interacts collaboratively with Vaccine Research Center (VRC) Office of Regulatory Sciences and Project Management groups.

+ Serve as subject matter expert for Vaccine Production Program (VPP) process development staff for raw material sourcing and product testing strategies.

+ Interact with the VRC pilot plant manufacturing, regulatory, and quality assurance staff.

+ Review and provide comments, recommendations, and strategy 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.

+ Serve as the Subject Matter Expert (SME) for lyophilization programs.

+ Design and implement (in collaboration with VPP management) a lyophilization process development program within the VPP formulation group, including the following sub-tasks:

+ Design lyophilization formulation and process development studies

+ Oversee the technical execution of those studies by Formulation personnel, and personally execute studies as needed.

+ Analyze, collate and interpret study data (directly and that analyzed by team members) based on technical expertise, previous project experience, organization knowledge and accepted scientific field literature.

+ Provide strategic guidance and technical instruction in the area of lyophilized product development to all formulation team members.

+ Provide strategic guidance and technical instruction in the area of lyophilized product development to all analytical team members as needed.

+ Remain current on lyophilization and similar technologies for current and future product development.





REQUIREMENTS: The contractor must have:




+ Ph.D. in Pharmaceutics, Chemistry, Biochemistry, or a related discipline.

+ M.S. and 3 years of relevant additional experience may be considered equivalent to a PhD

+ Three to six (3-6) years of industry, government or equivalent in protein formulation or a related field (post-doctoral experience may be considered equivalent on a candidate by candidate basis).

+ Extensive experience with the design and execution of studies to evaluate the physical and chemical characterization and stability of proteins and vaccines, including adjuvanted products.

+ Strong experience in the theoretical basis for the formulation and stability of proteins and vaccines, including adjuvanted products.

+ Strong background in both physical and chemical stability of proteins, including thorough understanding of biophysical and bioanalytical properties of proteins and biologics as applied stability and formulation.

+ Hands-on experience in the theory, use, data analysis, and data interpretation of majority of the following techniques:

+ Calorimetric analysis (Differential Scanning Calorimetry and Isothermal Chemical Denaturation)

+ Circular Dichroism

+ Intrinsic and extrinsic Fluorescence spectroscopy

+ Particle analysis (MFI, Nanosight, DLS, LO/HIAC)

+ Classic protein biochemistry sample handling and analysis (UF/DF, SDS-PAGE, Western Blot)

+ Chromatography (SEC, RP)

+ Experience in leading a development team, including technical instruction of junior associates, project scheduling and resource management.

+ Experience in active participation on cross-functional project teams.

+ Experience in data analysis and experimental design software packages (e.g. Prism, SigmaPlot, MicroCal Origin, JMP, etc.).





PLEASE APPLY ONLINE



Note that the phone number for our NIH branch is not listed. Due to the high volume of inquiries, we regret that we cannot accept phone calls. All qualified candidates will be contacted.




**AboutKelly Services** ****



As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2019-10-30 Expires: 2019-12-05

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Senior Scientist (Formulation & Analytical Development) - NIH - Gaithersburg

Kelly Services
Gaithersburg, MD 20898

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