Senior Downstream Process Scientist, Viral Vector

ProBio; Pennington (NJ); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Parental leave

Generous PTO

FSA/HSA & life/AD&D

Commuter benefits

Wellbeing programs

Job summary

GenScript USA Inc./ProBio Inc. is seeking a skilled downstream process development scientist to translate research into GMP-compatible manufacturing for viral vector processes.

The role involves developing, scaling, and evaluating technology transfer of LVV/AAV workflows, with opportunities to lead a small team as needed. The candidate should have extensive bench experience in bioprocessing, strong DOE/statistics skills, and a track record in regulatory CMC contexts.

Qualifications

• Advanced degree (M.S./Ph.D.) in biotech-related field with 5+ years industry experience.
• Experience with LVV and AAV process development is a plus.
• Strong understanding of process scale-up, DOE, and statistical analysis.
• Experience in regulatory CMC affairs for FDA/EMA is a plus.
• Ability to lead translation to GMP manufacturing and potentially lead a small team.

Responsibilities

• Hands-on development and optimization of downstream unit operations (TFF, chromatography, viral clearance, filtration).
• Plan and execute LVV/AAV purification experiments; analyze and report data.
• Collaborate with internal/external partners to evaluate new bioprocessing techs.
• Support process transfer, cGMP risk evaluation, and deviation management with cross-functional teams.
• Maintain detailed project timelines and documentation.
• Prepare CMC sections for regulatory submissions and progress reports.
• Present updates to management on process development and manufacturing support activities.
• Read literature to generate ideas for process design and development.
• Perform other duties as assigned.

Skills

DOE & stats

Communication

Independent work

Documentation

Team collaboration

Education

Master’s or PhD in biotech/related field

Job description

GenScript USA Inc./ProBio Inc. is seeking a skilled downstream process development scientist to translate research into GMP-compatible manufacturing for viral vector processes.

The role involves developing, scaling, and evaluating technology transfer of LVV/AAV workflows, with opportunities to lead a small team as needed. The candidate should have extensive bench experience in bioprocessing, strong DOE/statistics skills, and a track record in regulatory CMC contexts.