Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Biotherapeutics R&D
Job Category:
Scientific/Technology
All Job Posting Locations:
Malvern, Pennsylvania, United States of America
Job Description:
We are searching for the best talent for a Principal Scientist, In-vivo CAR-T, to be based on-site in Malvern, PA.
Purpose:
The Principal Scientist will support the development, optimization, and scale-up of lentiviral vector (LVV) drug product processes from early to late-stage development. The role combines hands-on laboratory work with strong cross-functional collaboration to ensure robust, scalable, and GMP-ready processes.
Key Responsibilities:
Lead, design, and execute LVV process development studies across early and late development stages
Collaborate with modelling experts and data scientists to identify opportunities where modelling or machine learning can reduce experimental burden, improve robustness, or define process design space.
Perform hands-on laboratory work including process design, optimization, and characterization
Analyze and interpret data to support process understanding, optimization, and decision-making
Support process characterization activities, including identification of CPPs and development of robust processes
Contribute to scale-up and manufacturing readiness, including support of technology transfer to internal sites or CMOs
Collaborate cross-functionally with Analytical Development, MSAT, Quality, Manufacturing, and Regulatory teams to ensure alignment on process strategy and execution
Document experimental work and results in accordance with GxP and data integrity requirements
Participate in troubleshooting activities and continuous process improvement initiatives
Qualifications:
Required:
Ph.D. 2-4 years experience, B.S. or M.S. with 6-8 years of experience in an appropriate scientific discipline (Life Sciences or Chemical Engineering) is required
Relevant experience in process development of viral vectors and/or LVV formulation development
Strong hands-on laboratory experience in drug product or viral vector development
Understanding of process scale-up, technology transfer, and GxP principles
Ability to manage/collaborate in a matrix environment
Strong scientific problem-solving and data interpretation skills
Hands-on, proactive, and detail-oriented approach
Ability to work effectively in a cross-functional, matrixed environment
Clear and concise communication skills (written and verbal)
Ability to manage multiple priorities in a dynamic development environment
Preferred:
Experience with LVV platforms, viral vectors and/or advanced therapies
Familiarity with process validation (e.g., LCPV) and manufacturing support
Exposure to both early and late-stage development or commercial readiness activities
Required Skills:
Preferred Skills:
Analytical Reasoning, Biochemistry, Biotechnology, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Coaching, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Organizing, Pharmacovigilance, Presentation Design, Process Improvements, Productivity Planning, Scientific Research
