Sr. Scientist (Downstream Process Development)

Job Description

Job Description

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 have an opening for a Senior Scientist (Downstream Process Development) to work on-site at the National Institutes of Health (NIH) in Gaithersburg, MD.

This is a long-term contract position which offers:
-    Competitive compensation and comprehensive benefit package
-    Optional health, vision, and dental plans
-    Paid leave as well as 11 paid federal holidays and 401K plan.  
-    Access to NIH’s unparalleled resources and niche scientific initiatives

KEY TASKS
(1) Oversee the development of downstream processes for clinical candidates and the process of tech transfer for clinical material generation
(2) Provide project support to develop downstream process methods that meet the product quality and recovery characteristics to guarantee successful production of clinical material.
(3) Serve as a subject matter expert (SME) in guiding purification strategies for new vaccine or therapeutic mAb candidates 
(4) Work with regulatory team to support IND submissions and other requests. 
(5) Oversee viral clearance strategies in relevant downstream processes and direct the viral clearance validation efforts 
(6) Plan and oversee downstream processes for toxicology lot material production. 
(7) Coordinate with manufacturing teams to ensure timely and scale-appropriate Technology Transfer is achieved
(8) Write/edit/review tech transfer documents to support downstream process Master Batch Record authoring.
(9) Serve as SME in downstream troubleshooting and facility fit calculations. 
(10) Serve as the Center’s downstream SME in external collaborations for clinical development projects
(11) Work to troubleshoot and improve downstream methods during the development cycle. This includes efforts in designing optimization studies (DOE with JMP) and streamlining efforts to ensure timely development schedules

REQUIREMENTS
(1) Ph.D. in Bioengineering, Chemical Engineering, Biochemistry, or a related field
(2) Minimum of 8 years of relevant experience with recombinant protein purification development for GMP clinical-phase products

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. In addition, this position offers employees the ability to earn up to 160 hours of paid time off annually and eleven paid holidays per benefit year. We also offer a generous defined 401(k) contribution to help you save for retirement. Visit -mykelly/perks/ for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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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, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Government Solutions?

Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly Government Solutions partners with these organizations to create expert talent solutions that solve the world’s most critical challenges. We offer a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technology, professional, and administrative support roles. Our experts will connect you to 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.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.