Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Biotherapeutics R&D
Job Category:Scientific/Technology
All Job Posting Locations:Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America
Job Description:We are searching for the best talent for Senior Scientist, Modeler, to join our team in Malvern or Spring House, PA.Purpose: In this role, you will serve as an individual contributor with expertise in applied modeling for Cell and Gene Therapy process and product development. The role will build fit-for-purpose models to support a broad range of data consumption use cases, including time series modeling, process characterization, optimization, scale translation, data interpretation, and decision-making across development teams. In addition, this role will require innate familiarity with the foundational requirement needed to support end-to-end Digital Twins by scalable modeling components that connect process/analytical knowledge, experimental data, mechanistic and statistical models, and user-facing tools. The successful candidate will collaborate closely with scientists, engineers, data and automation partners, Digital Twin leads, and project teams to identify high-value modeling use cases, translate scientific questions into model-based workflows, and deliver interpretable outputs that support Cell and Gene Therapy development strategies.
You will be responsible for:- Build and deploy fit-for-purpose models that support routine Cell and Gene Therapy development activities, including time series modeling, process characterization, optimization, scale-up/scale-down translation, comparability assessments, and data-driven troubleshooting.
- Develop mechanistic, statistical, hybrid, and/or machine learning models that translate complex development data into actionable insights for scientists, engineers, and project teams.
- Create user-accessible modeling solutions, dashboards, workflows, or decision-support tools that enable project teams to apply model outputs in day-to-day development decisions.
- Partner with scientists, engineers, data scientists, automation experts, IT architects, and Digital Twin leads to define data requirements, model inputs, and reusable data structures needed to support modeling workflows and broader data science initiatives.
- Contribute modeling components that support development of end-to-end Cell and Gene Therapy Digital Twins, including unit operation models, model-ready data structures, simulation workflows, and integration-ready outputs.
- Support model verification, validation, documentation, lifecycle management, and appropriate governance to ensure models are reliable, interpretable, and fit for their intended use.
- Define and lead departmental strategy for model implementation, including embedding modeling tools into scientific workflows and managing the associated change management activities.
- Advance a modeling culture within Cell and Gene Therapy development by identifying high-impact use cases, coaching scientific teams on model interpretation, and promoting data-driven decision-making.
Qualifications/Requirements:- Education: A minimum of a BS degree in a core science or engineering field, including biology, chemistry, chemical/biochemical engineering, biomedical engineering, physics, bioinformatics, data science, applied mathematics, or a related discipline, with at least 4 years of relevant experience; OR an MS or equivalent with at least 2 years of relevant experience; OR a PhD or equivalent with 0-1 year of relevant experience is required.
Skills/Experience:- Experience developing and applying time series, mechanistic, statistical, hybrid, machine learning, or multivariate models to complex scientific or engineering data is required.
- Ability to translate scientific questions into modeling strategies, define appropriate assumptions, communicate model limitations, and interpret model outputs for non-modeling audiences is required.
- Advanced skills with one or more programming languages or modeling environments are required. Examples may include Python, R, MATLAB, Julia, C++, Java, .NET, or equivalent tools.
- Proficiency with statistics, algorithm design, data analysis, model quality attributes, and model verification/validation concepts is required.
- Strong collaboration and communication skills, including the ability to work across global, cross-functional scientific, engineering, data, automation, and IT teams, are required.
- Experience with pharmaceutical development, biologics development, Cell and Gene Therapy process development, or GxP-adjacent development environments is preferred.
- Experience contributing to reusable modeling frameworks, simulation workflows, digital twin initiatives, decision-support applications, or user-facing modeling tools is preferred.
- Experience with process analytical technologies, in-line/at-line/off-line data streams, chemometrics, Raman spectroscopy, bioreactor data, chromatography data, or other process development data sources is preferred.
- Experience with cloud, software development, or collaboration tools is preferred. Examples may include Azure, AWS, Git, JIRA, Confluence, agile/scrum practices, application development, or full-stack development.
- Domestic and international travel up to 10%
#LI-Hybrid
Required Skills: Preferred Skills:Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Coaching, Consulting, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Pharmacogenetics, Pharmacovigilance, Process Improvements, Quality Assurance (QA), Relationship Building, Research Documents, Scientific Research, Technologically Savvy
