Biologist

GAP Solutions Inc; Gaithersburg (MD); On-site; USD 70,000 - 100,000; Full time

Job summary

GAP Solutions Inc in Gaithersburg, MD is seeking a Biologist to support the Vaccine Production Program at the VRC/NIAID. You will develop downstream purification processes for recombinant proteins, viruses, and VLPs, and optimize chromatography and filtration steps for clinical candidates and mAb products.

You will prepare materials, support tech transfer, write protocols, analyze data, and collaborate with cross-functional teams. Strong communication and meticulous record-keeping are essential.

Qualifications

• Bachelor’s degree in Bioengineering, Chemical Engineering, Biochemistry, or a related discipline.
• 1-2 yr experience in recombinant protein purification development for GMP clinical-phase products.
• Familiarity with computer software including word processing and data evaluation.

Responsibilities

• Develop downstream (purification) processes for recombinant proteins, virus vaccines, and VLPs.
• Design, develop and optimize chromatography and filtration step unit operations.
• Purify research-phase proteins and vaccines to support other groups or collaborators.
• Prepare materials (buffers, packed columns) for downstream activities.
• Support technology transfer to Lab’s Pilot Plant and assist with documentation.
• Write and review technical protocols and reports.
• Analyze and present data at group/department meetings.
• Coordinate with project management to meet milestones and deliverables.
• Create data analysis/visualization packages using Tableau or equivalent software.
• Design and execute process development studies for mRNA-LNP encapsulation.

Skills

Protein purification

Team player

Strong communication

Education

Bachelor’s degree in Bioengineering/Chemical Engineering/Biochemistry

Tools

Precision NanoSystem Ignite/Blaze

Knauer NanoScaler

Job description

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

Duties and Responsibilities:

• 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 candidates.
• Work 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 or external collaborators.
• Work to prepare necessary materials (buffers, packed columns, etc.) in support of downstream process activities.
• Support technology transfer of processes to Lab’s Pilot Plant for manufacture of clinical product through document generation and on-site support.
• Write and review technical protocols and reports.
• Analyze and compile data, present at various group/department meetings.
• Coordinate with project management to ensure development milestones and study deliverables are met in a timely manner
• Work with VPP Data Science and Automation (DSA) group to create platform data analysis/visualization packages using Tableau or equivalent software
• Support mRNA-Lipid Nanoparticle (LNP) program by designing and executing process development studies for mRNA-lipid nanoparticle encapsulation
• Serve as SME with operation and optimization of microfluidic systems, e.g. Precision NanoSystem, Inc Ignite and Blaze, and/or Knauer NanoScaler Impingement Jet Mixers
• Perform scale down and scale-up operations to support tech transfer to manufacturing and/or troubleshooting

Qualifications

Basic Qualifications:

• Bachelor’s degree in Bioengineering, Chemical Engineering, Biochemistry, or a related discipline.
• 1-2 yr experience in recombinant protein purification development for GMP clinical-phase products.
• Familiarity with computer software including word processing and data evaluation.

Preferred Qualifications:

• Demonstrated knowledge of maintaining accurate and detailed records.
• Must be a team player who can effectively work with members from cross-functional departments.
• Strong oral and written communication skills.
• Ability to communicate effectively, orally and in writing, with non-technical and technical staff.
• Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects

*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.

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.