DESCRIPTION:

The Biologics CMC Development team at AbbVie has a long and rich history of biologics development. Now located in a new state of the art facility in South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of CMC development with a primary focus on advancing biologic therapies, such as monoclonal antibodies, bi-specifics and novel modalities, to human clinical studies and eventual licensure. This role will be imbedded in a team of highly experienced scientists and managers who have directly enabled the development/IND submissions of 20+ novel oncology drugs and successfully filed two BLAs.

 

The Cell Culture Development Group in South San Francisco, CA is seeking a Senior Scientist I to join a talented and collaborative team to 1) develop and implement machine learning models for predicting optimal cell culture process performance and 2) develop robust, phase-appropriate cell culture processes for drug substance GMP production to enable human clinical studies and eventual licensure cell culture. As a senior scientist, you will be responsible for all aspects of ML model development and CMC cell culture program deliverables and help drive drugs substance cell culture development strategy though program lead assignments in cross-functional CMC teams.

 

This position is an onsite role in a lab-based function. To be successful, candidates must enjoy and thrive in an onsite, highly collaborative lab environment with face-to-face cross-functional interactions between scientists.

 

In this position, you will perform cell culture process modeling, cell culture process development, scale-up, and technology transfer activities in a well-supported and dynamic environment to help advance novel biotherapeutics into human clinical studies.

 

KEY 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 written communication skills, and adherence to good documentation practices

 

QUALIFICATIONS:

Basic:

·        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 typically 10 years of experience, MS or equivalent education and typically 8 years of experience, PhD and typically 0-4 years of experience

·        Must have industry or research experience in developing, implementing, and validating ML models

·        Must have a strong understanding of statistical methods, ML methodologies, and ML frameworks (e.g., Sci-kit Learn, TensorFlow, PyTorch)

·        Must demonstrate programming competency for model implementation in Python or equivalent

·        Must have experience in data visualization tools (e.g., Matplotlib, Plotly) to communicate model finding

·        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; active and quick learner; able to change course quickly as needed; raises the bar and is never satisfied with the status quo; open to suggestions and embraces the ideas of others; collaborative actively builds relationships with others

·        Experienced in authoring peer-reviewed publications, technical reports, regulatory documents, and/or presentations at conferences

·        Proficient with Microsoft Office software and strong familiarity with statistical modelling software/tools (e.g., JMP, SIMCA, Minitab, Design Expert)

Preferred:

·        Prior experience in developing and implementing ML models for biological data is highly desirable

·        Experience in implementing transfer learning is highly desirable

·        Expertise in programming (e.g., Python, Javascript, C++)

·        Experience in CMC cell culture process development is highly desirable

·        Demonstrated scientific aptitude through authorship of peer-reviewed publications

·        Strong understanding of design of experiments (DOE)