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**Position Objective:** Provide services as a Scientist in support of the overall functions of the Vaccine Research Center (VRC), Vaccine Production Program (VPP), Downstream Process Development (Purification) group within the National Institute of Allergy and Infectious Diseases (NIAID).

Duties and Responsibilities:

+ Independently execute and document downstream (purification) processes for recombinant proteins and nucleic acid constructs (including vaccine candidates, mAbs and/or pDNA constructs) in support of process development toward clinical manufacturing.

+ Responsible for set-up, execution, and documentation of downstream unit operation, as listed below, across a range of process scales up to 50 L cell culture harvest to purify products to targeted purity specifications:

+ Clarification/Depth Filtration

+ Column or Membrane Chromatography

+ Tangential Flow Filtration (TFF)

+ Nanofiltration

+ Independently operate downstream process development equipment including:

+ AKTA Avant/Pure/Pilot chromatography systems

+ TFF systems:

+ AMBR Crossflow

+ PendoTech Benchtop

+ Uniflux 10

+ KrosFlo KR2i

+ Work to prepare necessary materials (buffers, packed columns, etc.) in support of downstream process activities.

+ Ensure proper documentation of all development activities, including in lab notebooks and development reports.

+ Participate in tech transfer activities to support clinical manufacturing, including drafting Process Description documents, design and qualification of process scale down models, and provide limited person-in-plant activities during cGMP production runs.

+ Author or review process documents to support toxicology lot production including batch records and process summary reports.

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

+ Provide training to junior associates in lab operations, large scale equipment, and process execution, and writing SOPs.

+ Provide purified and in-process biologics, process protocols/worksheets, tech transfer process descriptions, and development reports.

Qualifications

Basic Qualifications:

+ **B.S degree in Chemistry, Biology, Biochemistry Life Sciences or a related discipline is required.**

+ **Five to ten (5-10) years’ experience in recombinant protein purification development and/or manufacturing of GMP clinical-phase products is required.**

+ **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 AEX, CEX, affinity, SEC, HIC.**

+ **Column packing and testing.**

+ **AKTA chromatography system.**

+ **Lab scale TFF systems.**

+ **Qualitative assays including SDS-PAGE and Western Blot.**

+ **UV/vis spectrophotometer.**

+ **Purification development experience for GMP products in biotech/pharmaceutical or related industry.**

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

Minimum Qualifications:

+ **Ability to multi-task and pay close attention to detail.**

+ **Excellent analytical and interpersonal, organizational, and time management skills.**

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

+ **Strong oral and written communication skills.**

*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at** **[email protected]** **. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law.

_This position is contingent upon contract award._