Senior Scientist, Downstream Bioprocessing (GMP)

Axle; Gaithersburg (MD); On-site; USD 120,000 - 127,000; Full time

Benefits offered by this job

Paid Time Off

401K match

Educational Benefits

Employee Referral Bonus

Flexible Spending Accounts

Job summary

Axle is seeking a Scientist to join our NIH-supported program at NIH/NIAID in Gaithersburg, MD. The role focuses on downstream process development for GMP clinical‑phase products and close collaboration with cross‑functional teams to ensure successful material generation.

The ideal candidate holds a PhD in a related field and 8+ years of protein purification experience, with strong documentation and communication skills to support regulatory submissions and tech transfer.

Qualifications

• PhD in Bioengineering, Chemical Engineering, Biochemistry, or a related discipline is required.
• Minimum of eight (8) years of experience in recombinant protein purification development for GMP clinical‑phase products.
• Strong documentation and record-keeping capabilities.
• Excellent communication and teamwork with cross‑functional groups.

Responsibilities

• Oversee downstream process development for VRC clinical candidates and tech transfer to VCMP.
• Support lead scientists in developing downstream methods meeting product quality and recovery goals.
• Collaborate with scientists to optimize development timelines and run validation studies (DOE with JMP).
• Coordinate with regulatory teams to support IND submissions.
• Lead viral clearance strategies and validation activities in downstream processes.
• Maintain and train lab staff on instruments and SOPs.
• Drive technology transfer to manufacturing with Process Descriptions/Flow Diagrams.

Skills

Recombinant protein purification

Documentation & records

Cross-functional collaboration

Oral & written communication

Education

PhD in Bioengineering, Chemical Engineering, Biochemistry or related

Tools

JMP (DOE)

Job description

Axle is seeking a Scientist to join our NIH-supported program at NIH/NIAID in Gaithersburg, MD. The role focuses on downstream process development for GMP clinical‑phase products and close collaboration with cross‑functional teams to ensure successful material generation.

The ideal candidate holds a PhD in a related field and 8+ years of protein purification experience, with strong documentation and communication skills to support regulatory submissions and tech transfer.