# Scientist

**Company:** [Axle](https://hotfix.jobs/companies/axle)
**Location:** Gaithersburg, MD
**Role:** Other
**Salary:** $120k – $127k/yr
**Experience:** 8+ years
**Skills:** recombinant protein purification, gmp, downstream process development, viral clearance, technology transfer, doe with jmp, ind submissions, process validation, biochemical sciences, Data Analysis
**Posted:** 2026-07-20

> Lead downstream process development and tech transfer for recombinant protein purification of GMP clinical-phase vaccine and mAb candidates at NIAID's Vaccine Research Center. Requires PhD and 8+ years experience in bioprocess development.

## Job Description

## Position Overview
A PhD in Bioengineering, Chemical Engineering, Biochemistry, or a related discipline is required, along with a minimum of eight (8) years of experience in recombinant protein purification development for GMP clinical-phase products.

## Additional Qualifications
- PhD in Bioengineering, Chemical Engineering, Biochemistry, or a related discipline
- Familiarity with computer software including word processing and data evaluation
- Minimum of eight (8) years of experience in recombinant protein purification development for GMP clinical-phase products
- 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

## Deliverables
- Meet with lab members to present updates — Ad-Hoc

## Statement of Work Details
- Oversee the development of downstream processes for VRC clinical candidates and the process tech transfer to the VCMP for clinical material generation for the VRC
- Provide project support to lead scientists and/or associates to develop downstream process methods that meet the product quality and recovery characteristics to guarantee successful production of clinical material
- Work with scientists and/or associates in troubleshooting and improving downstream methods during the development cycle, including efforts in designing optimization studies (DOE with JMP) and streamlining efforts to ensure timely development schedules
- Supports the planning and execution of research experiments in the context of the laboratory's overall research program
- Supports laboratory staff on research projects and techniques
- Work with regulatory team, as needed, to support IND submissions and other requests
- Oversee viral clearance strategies in relevant downstream processes and direct the viral clearance validation efforts (SEC evaluation of CRO vendors, scale-down method SOP/validation approval, etc.)
- Maintains laboratory equipment and the training of others in their use
- Train staff on the proper usage of laboratory instruments and equipment
- Assists in maintaining adequate space and facilities for ongoing and projected research studies
- Coordinate closely with Manufacturing teams to ensure timely and scale-appropriate Technology Transfer is achieved by: writing/editing/reviewing tech transfer documents (Process Descriptions/Process Flow Diagrams) to support VCMP downstream process Master Batch Record authoring; serving as Person in Plant or assigning a team designee for initial VCMP production runs; serving as SME in VCMP downstream troubleshooting and facility fit calculations; and serving as the VRC downstream SME in external collaborations for projects outside of VCMP-path clinical development
- Evaluates, analyzes and interprets research data, communicates results and methods in reports, presentations, and manuscripts
- Responsible for planning and overseeing the downstream processes for toxicology lot material production, including editing/approving all process protocols, managing execution thereof, and generating production reports following successful campaigns
- Coordinates with junior staff to modify research protocols
- Presents research at national scientific meetings and symposia
- Encourage and drive innovation to meet new downstream challenges and seek to publicly distribute novel technologies through presentations at conferences and/or publication in peer-reviewed journals
- Provides interpretation of results, guidance, and scientific support to the management team
- Serve as a subject matter expert (SME) in guiding purification strategies for new vaccine or therapeutic mAb candidates (both internal to the downstream team and throughout the VPP)
- Mentors junior level scientists
- Work closely with Project Managers to ensure downstream milestones are appropriately set and met on time

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