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Scientific Program Analyst

3 months ago

Gaithersburg, United States RJ IT Solutions Full time

RJIT Solutions is an information technology and bioscience company that specializes in providing innovative solutions in biomedical research and data science. We serve healthcare organizations by leveraging the expertise of our team in science, software engineering, program/project management. Our commitment to excellence has made us a trusted partner of top research organizations, including multiple institutes at the National Institutes of Health (NIH). At RJIT Solutions, we combine the agility of a small business with the comprehensive capabilities of a large organization to accelerate research and enhance decision-making processes in healthcare and research sectors. As part of our unrelenting focus on quality and compliance, RJIT Solutions’ delivery is based on Certified Matured Processes including CMMI L3 SVC, ISO 20000, ISO 27001, and ISO 9001 quality processes.


Technical Requirements: Scientific Program Analyst

• Support the Purification group of the Vaccine Production Program (VPP) Labs of the Vaccine Research Center.

• Develop downstream (purification) processes, under the supervision of a project lead scientist, for recombinant proteins, virus vaccines, and virus-like particles (VLP) that may be used as clinical vaccine candidates.

• Assist in the chromatography process development unit operations.

• Provide critical process step assessment and experimental design to define optimal process parameters for chromatography unit operations.

• Train team members in large-scale unit operation such as AxiChrom column packing and Pilot-scale chromatography execution.

• Work independently and collaboratively within the purification group to design, develop and optimize chromatography and filtration step unit operations to support process development of clinical trial vaccine candidates and mAb products.

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

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

• Perform protein/small molecule conjugation experiments to support method development or conjugate-based vaccine candidates.

• Support technology transfer of processes to VRC Pilot Plant for manufacture of clinical product including authoring process descriptions, reports, and on-floor support.

• Lead consortium authorship efforts in project-specific technical reports and protocols.

• Assist with writing training documents, SOPs, other equipment supporting documentation.

• Author process documents to support toxicology lot production including batch records

and process summary reports.

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


Other Requirements:

• Telework may be authorized if approved by the Task Leader, COR, and the Contracting Officer.


Specific Qualifications:

• M.S degree in Chemistry, Biology, Biochemistry Life Sciences or a related discipline.

• Minimum of five (5) years of experience in recombinant protein purification 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 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 process development in biotech/pharmaceutical or related industry (experience in clinical manufacturing is highly desirable).

• 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.