JobWatch

30 days old

Scientist (GMP experience) - NIH - Gaithersburg, MD

Kelly Services
Gaithersburg, MD 20898
Kelly Government 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 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 Scientist with GMP environment 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:




+ Support the Downstream Process Development (purification) group of the Vaccine Production Program (VPP) at the Vaccine Research Center.

+ Develop downstream processes, with minimal supervision, for recombinant proteins such as monoclonal antibodies, subunit or nanoparticle vaccines, and virus-like particles (VLPs) that may be used as clinical therapeutic or vaccine candidates.

+ Work independently and collaboratively within the purification group to design, develop and optimize chromatography, Tangential Flow Filtration (TFF), and Normal Flow Filtration (NFF) processes for all clinical trial vaccine candidates.

+ Apply process optimization techniques, such as Design of Experiments (DoE) or other statistical design approaches.

+ Serve as a functional lead and/or Subject Matter Expert (SME) in an inter-department Chemistry, Manufacturing, and Control (CMC) team with responsibilities for the following processes: chromatography, depth filtration, nano-filtration, and tangential-flow filtration (TFF).

+ Train associate scientists in the execution of chromatography and filtration processes.

+ Support Viral Clearance Validation studies by traveling to CMO/CRO sites to perform and/or oversee viral clearance chromatography and filtrations processes.

+ Work collaboratively with all VPP departments to coordinate schedules, material needs, and other deliverables in order to advance site-wide project goals.

+ Purify research-phase recombinant proteins, virus vaccines and/or virus-like particles in support of other groups at the VRC.

+ Analyze and compile data, present at various group/department meetings.

+ Represents the VPP at external conferences, workshops, and/or seminars.

+ Pursue novel technologies to advance the capabilities of the VPP.

+ Write and/or review process batch records for toxicology batch productions.

+ Write and/or review technology transfer documents in support of GMP manufacturing.

+ Write and/or review appropriate CMC sections of IND filings (e.g. Process Description Summaries) to support VRC regulatory group.





REQUIREMENTS: The contractor must have:




+ Ph.D. in Chemical Engineering, Biochemistry, Chemistry, or related Sciences field.

+ M.S. degree with 7 years relevant experience will also be considered.

+ Two (2) to Ten (10) years of experience in industry-relevant recombinant protein downstream process development for GMP clinical-phase products.

+ Demonstrated knowledge of maintaining accurate and detailed records.

+ Demonstrated expertise in the following techniques or tools for protein purification and characterization:

+ Column chromatography for protein purification by means of AEX, CEX, affinity, SEC, HIC

+ Column packing and testing

+ AKTA chromatography system

+ Lab scale TFF systems

+ Lab scale nano-filtration systems

+ Qualitative assays including SDS-PAGE and Western Blot

+ UV/vis spectrophotometer

+ Previous work experience in a GMP environment in biotech/pharmaceutical industry.

+ Must be a team player who can effectively work with members from cross-functional departments.

+ Strong oral and written communication skills.

+ Familiarity with computer software including word processing and data evaluation.

+ Knowledge and use of statistical design of experiments (DoE).

+ Excellent analytical, organizational, and time management skills.





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.




**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. Its just another way we make the job search work for you.




**About Kelly** ****



Kelly connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. Were always thinking about whats next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 500,000 people around the world, and we connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice.


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 Law.
Posted: 2020-06-08 Expires: 2020-08-08

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Scientist (GMP experience) - NIH - Gaithersburg, MD

Kelly Services
Gaithersburg, MD 20898

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast