Gene Vector Senior Scientist , Process Development

Major responsibilities

• Develop and drive robust upstream process workflows to support efficient plasmid DNA and viral vectors manufacturing. This involves designing and executing experiments, analyzing data, and providing science-based recommendations for process improvement.
• Apply in-depth expertise in E. coli fermentation, mammalian cell culture, multivariate Design of Experiments (DoE), and in-process analytics to design, scale up, improve productivity, optimize parameters for product quality, characterize upstream production processes, and minimize process- and product-related impurities.
• Drive platform development and evaluate new technologies and innovations (i.e. industry trends, emerging technologies, and best practices in plasmid DNA development) to improve process performance and operational efficiency, enable predictive process modeling, and strengthen process control and robustness.
• Support technical investigations via equipment troubleshooting and testing to identify root causes.
• Analyze, document, and present experimental data and findings to internal teams and relevant stakeholders as needed.
• Work closely with cross-functional stakeholders to ensure programs are on track and to facilitate the seamless transfer of developed processes to manufacturing teams, providing detailed documentation, training, and ongoing technical support.
• Ensure accurate, complete, and compliant documentation and record keeping, including databases, batch records, ELNs, and other required technical records.
• Author and review technical documents such as laboratory and equipment SOPs, batch records, process development reports, and process transfer documents. Compile and/or support the preparation of documentation for regulatory submissions, as required.

Education, Qualifications, Skills And Experience

• M.S. or above in Biology, Biotechnology, Microbiology, Biochemical Engineering, or equivalent related fields. Candidates with more extensive relevant experience will be considered for a senior scientist position.
• Minimum of 3 years of hands-on experience in upstream process development within biopharmaceutical or biotechnology settings, including manufacturing, pilot-scale, and/or laboratory-scale environments. The candidate should have direct experience in upstream process operations, including development of scalable suspension processes for plasmid DNA and/or viral vector product manufacturing.
• Experience in plasmid DNA production and scale-up bioreactor operation is a must.
• Strong knowledge and hands-on experience in upstream Batch / Fed-Batch process development, upstream process optimization, operation of bioreactors, and process scale-up / scale-down model development.
• Demonstrated ability to coach and mentor junior scientists.
• Creative thinker that can identify and efficiently improve processes to address issues and gaps.
• Independently motivated and good problem-solving ability.
• Proficiency with statistical analysis software (e.g., JMP/MODDE/Minitab) is highly desired.
• Attention to detail and accuracy in developing, reviewing, and following protocols, SOPs, batch records and technology transfer documents is a must.
• Demonstrated ability to collaborate effectively across cross-functional teams to meet project deliverables and timelines.
• Strong verbal and written communication, decision-making and organizational skills.