About the position
As part of the company's Research Laboratories, the Sterile Product Development (SPD) department provides technical process leadership and laboratory capabilities in support of clinical and commercial stage pipeline research, development, and manufacturing for small and large molecule therapeutics and vaccines in support of our company's pipeline. For pipeline programs, SPD leads various development and commercialization activities, including formulation and process characterization, collaborates on technology transfer to internal and external manufacturing sites, process validation, and authoring of global regulatory submissions. Additionally, SPD provides our company with deep formulation and manufacturing technology support, process enhancements, next generation drug product development and implementation. Under the Sterile Product Development (SPD), working in conjunction with internal and external partners, this individual will be central to building and applying Multiscale and Multiphysics modeling approaches—from molecular-level coarse-grained simulations to continuum-scale process modeling—to advance the development of sterile small molecule therapeutics, biologics, and vaccines. This individual will play a critical role in supporting clinical stage development, process characterization, and validation activities with direct line-of-sight to commercialization and licensure. The modeling insights obtained will advance the fidelity of small and large molecule research, development, commercialization and manufacturing across a diversity of unit operations frequently involving fluid flow, structural mechanics, and heat transfer.
Responsibilities
- Designing and developing sterile products for biologics, small molecule, peptide, and oligonucleotide drugs for injectable and ophthalmic routes of administration
- Develop multiscale models integrating coarse-grain molecular dynamics (CGMD), CFD-FEA Multiphysics to predict how process conditions (e.g., mixing shear, freeze-thaw, pumping, filling) impact protein stability, aggregation, and product quality.
- Deploy portfolio of modeling and in silico tools to drive superior outcomes in the development, scale-up and manufacturing of a broad and diverse pipeline of our company's biologics and vaccine candidate molecules across a range of traditional and novel process unit operations.
- Collaborate closely with Sterile Product Development (SPD) teams to de-risk sterile process scale-up, optimize formulation robustness, accelerate, and support clinical-to-commercial development of sterile therapeutics and vaccines across both small and large molecule modalities.
- Design and validate models through small-scale (‘scale-down’) experiments to ensure predictive accuracy and scalability.
- Provide technical leadership during critical investigations (e.g., deviations, root-cause analysis) to rapidly resolve process and product challenges.
- Manage complete modeling project operations including but not limited to project scope, input data requirements, deliverables, reports, and effectively communicating modeling predictions across integrated drug product operations.
- Establish the best practices and workflow for model development, pre/post processing, computing resources, and data storage.
- Actively interact and communicate with internal and external stakeholders to integrate novel modeling approaches to achieve desired business outcomes.
- Represent functional areas on cross-functional and cross-divisional technical teams through matrix and direct management structures.
Requirements
- BS with 5+ of relevant experience or MS with 3+ years with educational Background in Life Sciences, Chemical Engineering, Mechanical Engineering, Materials Science and Engineering, Control or Computer Engineering or other relevant background.
- Expertise in CFD (ANSYS Fluent/Star-CCM+/MSTAR, COMSOL, Open FOAM) and multiphase/reacting flows (VOF, DEM, Eulerian-Lagrangian methods).
- Proven experience in coarse-grain/molecular modeling (e.g., CULGI, MOE, MAESTRO) and its integration with continuum-scale processes.
- Strong scientific programming skills (Python, MATLAB, R, JMP) for model coupling, data analytics, and HPC workflows (Linux/Cloud).
- Hands-on experience validating models with experimental data (e.g., rheology, particle imaging, stress studies) and designing small-scale prototypes.
- Ability to translate molecular mechanisms (e.g., protein aggregation, shear stress) into predictive process-scale insights.
- Exceptional problem-solving and communication skills; thrive in a fast-paced, interdisciplinary environment.
Nice-to-haves
- PhD in Chemical Engineering, Mechanical Engineering, Computational Physics, or related field with 2+ years of industry/academic experience in multiscale CFD modeling.
- Experience in Sterile Drug Product development and CMC development workflows, particularly unit operations such as mixing, filling, pumping, freeze-drying, or filtration.
- Familiarity with regulatory trends supporting mechanistic modeling and digital twin applications in cGMP settings (e.g., ISO, CFR, ICH, and USP).
- Applied understanding of QbD principles, design of experiments (DOE), and model validation frameworks for process modeling.
- Working knowledge of statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for biologics processes with experience in statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software).
- Knowledge of emerging modeling methods such as reduced-order modeling (ROM), physics-informed neural networks (PINNs), and hybrid mechanistic/data-driven modeling.
- Prior contributions to technology transfer, process troubleshooting, or process robustness assessment using modeling.
Benefits
- Bonus eligibility
- Long term incentive if applicable
- Health care and other insurance benefits (for employee and family)
- Retirement benefits
- Paid holidays
- Vacation
- Sick days
