Senior Scientist, Downstream Process Development – Viral Vectors

GenScript Biotech Corp.; Northern (KY); Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical insurance

401(k) with company match

Parental leave

Paid time off

HSA/FSA

Job summary

GenScript USA Inc/ProBio Inc. seeks a Sr. Scientist for Downstream Process Development to translate research processes into GMP manufacturing. The role will develop, scale up, and evaluate technology transfer for viral vector operations, potentially leading a small team.

The candidate will design experiments, work cross-functionally, and contribute to regulatory submissions, staying current with gene therapy literature to drive process advancement.

Qualifications

• Master’s or Ph.D. degree with 5+ years’ relevant industry experience in biotech development, with LVV and AAV process exposure.
• Experience in viral vector process development and manufacturing is highly preferred.
• Strong understanding of process scale-up and scale-down modeling.
• Good understanding of DOE and statistical analysis.
• Experience with FDA/EMA CMC regulatory affairs is a plus.

Responsibilities

• Hands-on development and optimization of downstream unit operations for viral vector manufacturing.
• Plan and execute AAV/LVV purification experiments and report data.
• Collaborate with internal/external partners to implement new bioprocessing technologies.
• Assist cross-functional teams (Analytic, MFG, Supply Chain, QA/QC) with tech transfer and cGMP risk evaluation.
• Contribute to project timelines and regulatory submissions (IND, Annual Reports, BLA).
• Present progress updates to management and read current literature to inform process design.

Skills

Downstream processing

Viral vector purification

DOE

Scale-up

cGMP

Team collaboration

Education

Ph.D. or Master's in Chemical/Biochemical Engineering or Biological Sciences

Tools

TFF

Affinity chromatography

Ion exchange

Multimodal chromatography

Viral clearance

Sterile filtration

Job description

GenScript USA Inc/ProBio Inc. seeks a Sr. Scientist for Downstream Process Development to translate research processes into GMP manufacturing. The role will develop, scale up, and evaluate technology transfer for viral vector operations, potentially leading a small team.

The candidate will design experiments, work cross-functionally, and contribute to regulatory submissions, staying current with gene therapy literature to drive process advancement.