Senior Scientist I, Biologics Drug Substance Development (Cell Culture Development)

Role Summary

Senior Scientist I, Biologics Drug Substance Development (Cell Culture Development) role focused on developing and implementing machine learning models for predicting cell culture process performance and advancing robust, phase-appropriate cell culture processes for GMP production.

Responsibilities

• Develop, implement, refine, and validate machine learning (ML) models for predicting cell culture process performance
• Communicate model findings and suggest experimental strategy and/or workflow improvements to support early- and late-stage development
• Design and execute scalable ambr250, 2L, 50L, 200L and 500L single use bioreactors processes
• Design scalable inoculum expansion and master cell bank generation processes
• Design and execute small scale and pilot scale depth filtration and centrifugation primary recovery processes
• Lead the tech transfer of cell culture and primary recovery processes to GMP manufacturing facilities in other locations
• Provide person-in-plant support at the GMP manufacturing facility
• Represent the cell culture development group in cross-functional meetings and collaborate closely with cell line, purification, analytical and formulation development leads to meet project deliverables and timelines
• Author and review technical reports, GMP campaign summary reports and relevant sections in regulatory filings
• Actively seek out opportunities to optimize our platform or enhance our understanding of cell culture processes
• Publish or present scientific findings in peer-reviewed journals, internal or external conferences or consortia
• Display effective organization, verbal and written communication skills, and adherence to good documentation practices

Qualifications

• Scientific degree in computer science, statistics and applied mathematics, computational biology, bioinformatics, data science, chemical engineering, bioengineering, biotechnology, or a related field, with BS or equivalent education and 10+ years of experience, OR MS or equivalent education and 8+ years of experience, OR PhD and 0+ years of experience
• Must have industry or research experience in developing, implementing, and validating ML models
• Strong understanding of statistical methods, ML methodologies, and ML frameworks (e.g., Sci-kit Learn, TensorFlow, PyTorch)
• Programming competency for model implementation in Python or equivalent
• Experience in data visualization tools (e.g., Matplotlib, Plotly) to communicate model findings
• Proficient in aseptic technique
• Basic understanding of mammalian cell and molecular biology and cell culture bioprocess engineering concepts
• Experienced in developing and executing mammalian suspension cell culture processes in shake flasks, ambr250, and/or 2L bioreactors
• Strong attention to detail; fast learner; collaborative and open to new ideas; strong teamwork
• Experience authoring peer-reviewed publications, technical reports, regulatory documents, and/or conference presentations
• Proficient with Microsoft Office and familiarity with statistical modelling tools (e.g., JMP, SIMCA, Minitab, Design Expert)

Preferred

• Prior experience developing and implementing ML models for biological data is highly desirable
• Experience implementing transfer learning is highly desirable
• Programming expertise (e.g., Python, Javascript, C++)
• Experience in CMC cell culture process development is highly desirable
• Demonstrated scientific aptitude through peer-reviewed publications
• Strong understanding of design of experiments (DOE)