The Senior Scientist I will be part of a centralized modeling team supporting the development and implementation of a broad range of models across early- and late-stage bioprocess development for diverse biologic modalities, including monoclonal antibodies, antibody-drug conjugates, bispecifics, and gene therapies. Working collaboratively across functions, the scientist will develop and apply innovative modeling and experimental approaches to address scientific and process development challenges, including scale-up and technology transfer. The team’s mission is to continually build next-generation modeling capabilities through deep integration with artificial intelligence (AI) tools, delivering business impact with agility.
Responsibilities:
- Independently conceptualize, build, and apply fit-for-purpose models for upstream cell culture and downstream purification processes across early- and late-stage bioprocess development.
- Translate scientific and business challenges into modeling strategies that deepen process understanding, guide process optimization, and support scale-up and technology transfer.
- Advance next-generation modeling capabilities through deep integration with AI tools to accelerate model development and implementation and deliver business impact with agility.
- Work closely with the Automation and Digitalization team to establish data workflows and integrated tools that enable efficient model building and implementation.
- Integrate multidisciplinary data and scientific fundamentals to assess model performance, assumptions, and limitations, draw actionable conclusions, and resolve key project challenges.
- Collaborate in an agile, fast-paced matrix team spanning IT, Data Science, CMC, and Development to align priorities, adapt to evolving needs, and deliver modeling solutions; provide scientific mentorship and technical guidance as appropriate.
- Communicate modeling approaches, results, limitations, and recommendations clearly and efficiently to project teams and leadership to support timely, informed decisions.
- Support model transfer and lifecycle management, including implementation, documentation, maintenance, updates, and assessment of continued fitness for purpose, in accordance with applicable corporate, safety, and GxP standards.
- Serve as a primary author of modeling-related technical and regulatory documents, peer-reviewed publications, and scientific presentations, and contribute to patentable innovations as appropriate.
- Proactively evaluate relevant literature and emerging technologies, identify innovative modeling opportunities aligned with the centralized team’s strategy, and incorporate advances into projects and broader modeling capabilities.