Senior Scientist, Viral Vector Process Development

BioSpace; United States; On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid parental leave

Paid time off

Flexible spending accounts

Health savings accounts

Life and AD&D insurance

Disability insurance

Job summary

GenScript USA Inc/ProBio Inc. seeks an experienced downstream process development specialist to translate research to GMP manufacturing for viral vectors. The role focuses on development, scale-up, and technology transfer of LVV and AAV processes, with opportunities to lead a small team.

The candidate will work across cross-functional teams, contribute to regulatory submissions, and stay current with gene and cell therapy literature to drive process improvements.

Qualifications

• Master’s or Ph.D. degree with 5+ years’ relevant industry experience in Chemical/Biochemical Engineering, Biological Sciences, or a related scientific discipline in biotech development with particular experience in gene and cell therapy product design.

Responsibilities

• Hands-on experimental work in downstream unit operations (TFF, Affinity/Ion Exchange/multimodal Chromatography, Viral clearance, Sterile filtration) for viral vector manufacturing.
• Contribute to planning, design, and execution of AAV/LVV purification experiments and report data.
• Collaborate with internal/external partners to evaluate new bioprocessing technologies.
• Support process technology transfer, cGMP risk evaluation, and deviation management with cross-functional teams.
• Prepare CMC sections for regulatory submissions (IND, Annual Reports, and BLA).
• Present updates to project or upper management on process development and manufacturing support activities.

Skills

LVV process development

AAV process development

Design of Experiment

Statistical analysis

CMC regulatory affairs

GMP knowledge

Documentation & record keeping

Independent work

Education

Master’s or Ph.D. in Chemical/Biochemical Eng or related

Job description

GenScript USA Inc/ProBio Inc. seeks an experienced downstream process development specialist to translate research to GMP manufacturing for viral vectors. The role focuses on development, scale-up, and technology transfer of LVV and AAV processes, with opportunities to lead a small team.

The candidate will work across cross-functional teams, contribute to regulatory submissions, and stay current with gene and cell therapy literature to drive process improvements.