Drug Product Formulation Scientist

Position Overview:Our Eurofins PSS team is seeking a Drug Product and Formulation Scientist to work onsite supporting our client's Drug Product and Formulations development activities for lentiviral vector (LVV)-based gene therapy products.  The successful candidate will help design and execute bench-scale experiments and contribute to technical documentation for drug product development.  This role will parter closely with process development, analytical development, and technical operations teams, operating with moderate supervision while building toward independent ownership of formulation and drug product workstreams. This is an excellent opportunity for a motivated scientist to build formulation expertise on a novel gene therapy program.Responsibilities:Support formulation and drug product development activities by executing studies to:Optimize formulation buffer via buffer/excipient screening, using accelerated stress and long-term storage stability studies to assess and improve conditions that support vector stability.Develop and optimize product filtration methods (e.g. sterile filtration compatibility, membrane selection, filter fouling/throughput studies), evaluating impact on vector recovery.Enable and optimize GMP-compliant drug product manufacturing workflows, completing studies related to (but not limited to) scale-up, in-process hold times, fill/finish, and container closure evaluation.Evaluate in-use compatibility (e.g., shelf-life, clinical formulation, and infusion set hold time studies) supporting clinical administration of the drug product.Perform biophysical characterization of the vector (e.g., particle analysis via HIAC) and support development and optimization efforts for new characterization methods (e.g. FlowCam or NanoFCM) as needed.Support the technology transfer efforts by preparing documentation, data packages, and coordination of materials for internal teams or CDMO partnersMaintain accurate, compliant lab notebooks, data records, and sample tracking in a GLP environment.Draft protocols, study summaries, and technical reports, with guidance and review from senior team members.Contribute to regulatory filings (e.g. CMC sections of IND/CTA) as needed.Present data at technical forums.