Senior Scientist Multiscale Process Product Modeling
Senior Scientist Multiscale Process Product Modeling
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$ 114700 - 180500
1 Vacancy
Job Description
Job Description
As part of the compnays 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 companys 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 approachesfrom molecularlevel coarsegrained simulations to continuumscale process modelingto 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 lineofsight 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.
Primary Responsibilities:
Designing and developing sterile products for biologics small molecule peptide and oligonucleotide for injectable and ophthalmic routes of administration
Develop multiscale models integrating coarsegrain molecular dynamics (CGMD) CFDFEA Multiphysics to predict how process conditions (e.g. mixing shear freezethaw pumping filling) impact protein stability aggregation and product quality.
Deploy portfolio of modeling and in silico tools to drive superior outcomes in the development scaleup and manufacturing of a broad and diverse pipeline of our companys biologics and vaccine candidate molecules across a range of traditional and novel process unit operations. Example tools will include first principles & mechanistic modeling CFD modeling mathematical and statistical modeling of process control and characterization and advanced process control.
Collaborate closely with Sterile Product Development (SPD) teams to derisk sterile process scaleup optimize formulation robustness accelerate and support clinicaltocommercial development of sterile therapeutics and vaccines across both small and large molecule modalities.
Design and validate models through smallscale (scaledown) experiments to ensure predictive accuracy and scalability. Provide technical leadership during critical investigations (e.g. deviations rootcause 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 serving full panel of small and large molecule modalities in biologics and vaccine pipeline.
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 crossfunctional and crossdivisional technical teams through matrix and direct management structures.
Education Requirements (minimum):
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.
Required Experience and Skills:
Expertise in CFD (ANSYS Fluent/StarCCM/MSTAR COMSOL Open FOAM) and multiphase/reacting flows (VOF DEM EulerianLagrangian methods).
Proven experience in coarsegrain/molecular modeling (e.g. CULGI MOE MAESTRO) and its integration with continuumscale processes.
Strong scientific programming skills (Python MATLAB R JMP) for model coupling data analytics and HPC workflows (Linux/Cloud).
Handson experience validating models with experimental data (e.g. rheology particle imaging stress studies) and designing smallscale prototypes.
Ability to translate molecular mechanisms (e.g. protein aggregation shear stress) into predictive processscale insights.
Exceptional problemsolving and communication skills; thrive in a fastpaced interdisciplinary environment.
Preferred Experience and Skills:
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 freezedrying 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 reducedorder modeling (ROM) physicsinformed neural networks (PINNs) and hybrid mechanistic/datadriven modeling.
Prior contributions to technology transfer process troubleshooting or process robustness assessment using modeling.
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Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors which may include but not be limited to the primary work location and the chosen candidates relevant skills experience and education.
Expected US salary range:
$114700.00 $180500.00Available benefits include bonus eligibility long term incentive if applicable health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and sick days. A summary of benefits is listed here.
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Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
YesTravel Requirements:
10Flexible Work Arrangements:
Not ApplicableShift:
1st DayValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
05/3/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Senior IC
Employment Type
Full-Time
