Senior Scientist, Multiscale Process & Product Modeling
Apply NowCompany: Merck & Co, Inc
Location: Rahway, NJ 07065
Description:
Job Description
As part of the compnay'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.
Primary Responsibilities:
Education Requirements (minimum):
Required Experience and Skills:
Preferred Experience and Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining 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 candidate's relevant skills, experience, and education.
Expected US salary range:
$114,700.00 - $180,500.00
Available 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.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
Yes
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
05/3/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
As part of the compnay'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.
Primary 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. 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 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 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 cross-functional and cross-divisional 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/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.
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, 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.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining 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 candidate's relevant skills, experience, and education.
Expected US salary range:
$114,700.00 - $180,500.00
Available 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.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
Yes
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
05/3/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.