Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Biotherapeutics R&D
Job Category:Scientific/Technology
All Job Posting Locations:Spring House, Pennsylvania, United States of America
Job Description:We are searching for the best talent for a
Senior Scientist - Lentiviral Vector Upstream Process Development to be based in Spring House, PA.
Purpose:The Senior Scientist, Lentiviral Vector Upstream Process Development, will lead development, optimization, and characterization of scalable cell culture processes for cell therapy and CAR-T programs. This role will provide scientific leadership for early- or clinical-stage process development, with emphasis on cell culture and bioreactor execution at varying scales and data-driven process understanding, platform robustness and knowledge and optimization of upstream process technologies. This role will also support technology transfer to Johnson & Johnson's manufacturing sites, commercial manufacturing investigations and provide subject matter expert knowledge as part of life cycle management for cell therapy products in Johnson & Johnson's pipeline.
You will be responsible for:- Design and execute upstream process development studies for lentiviral therapeutic products and provide scientific guidance.
- Conduct cell culture experiments using shake flasks, bench-scale bioreactors, and automated high-throughput systems.
- Contribute to development of lentiviral processes to continuously improve productivity, quality, and manufacturability.
- Perform technology transfer to and collaborate with Johnson & Johnson's manufacturing sites
- Support existing and new commercial manufacturing investigations and provide subject matter expert knowledge as part of product life cycle management
- Apply statistical experimental design, data analytics, and online monitoring and visualization tools to strengthen upstream process understanding.
- Analyze and interpret process data using JMP, MiniTab, Python, Spotfire, or similar platforms.
- Evaluate emerging novel upstream technologies that improve process robustness and development efficiency.
- Collaborate closely with downstream, analytical, formulation, modeling, automation to align study design and deliverables
- Mentor junior scientists and provide scientific leadership across programs and cross-functional workstreams.
- Author technical reports, development summaries, scientific presentations, protocols, and regulatory-supporting documentation.
Qualifications:
Required:- PhD in Chemical Engineering, Biochemical Engineering, Biological Sciences, Biotechnology, or related field with 2+ years of relevant experience; OR BS or MS with 4-6 years of relevant experience.
- Experience with process development of viral based products.
- Experience in mammalian cell culture process development for biologics, cell and gene therapy, RNA therapeutics, or related viral vector modalities.
- Hands-on experience with cell culture, bioreactor operation, media optimization, process monitoring, and process scale-up.
- Strong data analysis, experimental design, and technical documentation skills.
- Demonstrated ability to independently design, execute, interpret, and communicate complex studies.
- Excellent written and verbal communication skills.
- Ability to work effectively in cross-functional team environments.
- Previous experience with technology transfer of a bioprocess to clinical or commercial GMP manufacturing is strongly preferred
- Occasional weekend work may be required
- Up to 10% domestic and international travel may be required
Required Skills: Preferred Skills:Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Coaching, Consulting, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Pharmacogenetics, Pharmacovigilance, Process Improvements, Quality Assurance (QA), Relationship Building, Research Documents, Scientific Research, Technologically Savvy
