LVV Upstream Senior Scientist II Full-time

Job Title

Major responsibilities

• Develop and drive robust LVV upstream process workflows to support efficient, scalable, and reliable manufacturing.

• Apply in-depth expertise in LVV production, including cell culture expansion, transient transfection or/and stable producer-cell systems, multivariate Design of Experiments (DoE), and viral harvest as well as process scale-up and optimization.

• Conduct hands-on experiments to evaluate innovative technologies and next-generation lentiviral vector platforms, collaborating with DSP and AD teams to implement robust processes for high-quality LVV production.

• Support technical investigations through troubleshooting and data analysis to identify root causes and implement effective solutions.

• Analyze, document, and present experimental data, conclusions, and recommendations to internal teams and relevant stakeholders, as required.

• Provide technical support, training, and SME knowledge to assist with the development of junior scientists.

• Collaborate with cross-functional stakeholders to keep programs on track and ensure the seamless transfer of developed processes to manufacturing teams, supported by thorough documentation, training, and ongoing technical guidance.

• Maintain accurate, complete, and compliant records, including databases, batch records, ELNs, and other required technical documentation.

• Draft and review technical documents, including laboratory and equipment SOPs, batch records, process development reports, and process transfer documents. Prepare or support documentation for regulatory submissions as required.

Education, Qualifications, Skills and Experience

• M.S. degree or higher in Biology, Biotechnology, or a related field, or an equivalent combination of education and experience.

• At least 4–5 years of hands-on experience in upstream process development or manufacturing in a biotechnology or pharmaceutical environment. Direct experience with HEK293 cell culture, cell expansion, feeding strategies, and transient transfection or stable cell-line production optimization for viral vectors, preferably lentivirus.

• Proven ability to develop and implement bioreactor scale-up and scale-down models. Experience operating suspension culture bioreactors is preferred.

• Self-motivated, with strong analytical and problem-solving skills and the ability to work independently.

• Proficiency in statistical analysis and design-of-experiments software, such as JMP, MODDE, or Minitab, is highly desirable.

• Strong knowledge of GMP manufacturing requirements and early-phase clinical CMC strategies.

• Exceptional attention to detail when developing, reviewing, and following protocols, SOPs, batch records, and technology-transfer documents.

• Proven ability to collaborate across functions and meet project timelines and deliverables.

• End-to-end experience with IIT, IND, or BLA projects is preferred.

• Strong written and verbal communication, decision-making, planning, and organizational skills.