Associate Principal Scientist, Biopharmaceutics

MSD; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Job summary

MSD in Rahway, NJ is seeking an Associate Principal Scientist to lead biopharmaceutics strategy for subcutaneously administered biologics across the development pipeline. You will work with formulation, analytical, device engineering, pharmacokinetics, and clinical pharmacology teams to apply mechanistic principles and quantitative modeling to optimize SC absorption, formulation, and device compatibility.

The role requires strong scientific rigor and matrix leadership to reduce clinical delivery

Qualifications

• PhD or MSc with extensive biologics drug product development experience.
• Deep knowledge of SC absorption, interstitial transport, and translational PK.
• Experience leading cross-functional matrix development teams.

Responsibilities

• Define integrated experimental and modeling strategies for formulation and device decisions.
• Translate preclinical findings to support formulation, device, and process changes.
• Evaluate immunogenicity risks and local tolerability related to delivery conditions.
• Communicate risks and recommendations at governance forums and regulatory submissions.
• Develop predictive tools and mentor scientists in translational biopharmaceutics.

Skills

Biopharmaceutics

Translational PK

Subcutaneous absorption

Regulatory submissions

Matrix leadership

Modeling and simulation

Regulatory strategy

Immunogenicity risk assessment

Education

PhD in Pharmaceutical Sciences

MS in a related field with industry experience

Tools

GastroPlus

Simcyp

Phoenix WinNonlin

PK-Sim

MATLAB

Python/R

Job description

We are seeking an experienced Associate Principal Scientist to join our team and lead biopharmaceutics strategy for subcutaneously (SC) administered biologics across the pipeline—from early formulation screening through late-stage commercialization and lifecycle management. Working in close collaboration with formulation, analytical, device engineering, pharmacokinetics, and clinical pharmacology teams, you will apply fundamental mechanistic principles, quantitative translational modeling, and experimental frameworks to evaluate SC absorption, formulation and device compatibility, product bridging, and immunogenicity risk. The ideal candidate will combine deep scientific rigor with strong matrix leadership to de-risk clinical delivery and influence program decision-making at key governance milestones.

Key Responsibilities

• Lead SC Biopharmaceutics Strategy: Define integrated experimental and modeling strategies to guide formulation, dose volume, injection site, and device decisions across development.
• Drive Translation and Product Bridging: Apply mechanistic and quantitative approaches to translate preclinical findings, assess exposure variability, and support formulation, device, process, scale, and site changes.
• Assess Immunogenicity and Bio performance Risk: Evaluate how product quality attributes, formulation, particles, aggregates, and delivery conditions may affect local tolerability, pharmacokinetics, and immunogenicity.
• Influence Governance and Regulatory Strategy: Communicate risks and recommendations at program and governance forums and author or review relevant regulatory submissions and health authority briefing materials.
• Advance Scientific Capabilities: Develop predictive tools and experimental approaches, mentor scientists, and contribute to external scientific engagement.

Qualifications

Education Minimum Requirements

• Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemical or Biomedical Engineering, or related scientific discipline with 3+ years of relevant experience; OR
• Master’s degree in a relevant discipline with 8+ years of relevant industry experience.

Required Experience and Skills

• Demonstrated expertise in biologics drug product development with a strong focus on the mechanistic principles governing subcutaneous absorption, interstitial transport, and translational pharmacokinetics.
• Proven track record as a biopharmaceutics, formulation, or translational PK lead within cross-functional matrix development teams.
• Hands-on experience developing and executing biopharmaceutics risk assessments for product comparability, device transitions (e.g., vial to PFS/autoinjector), and formulation bridging.
• Working understanding of the interplay between biologic quality attributes (e.g., aggregation, opalescence, viscosity, particle formation), delivery devices, and clinical immunogenicity / ADA impact.
• Strong critical thinking and problem solving, with the ability to translate complex or incomplete data into clear development decisions.
• Outstanding oral, written, and presentation skills, with the ability to communicate technical complexity clearly to senior leadership and cross-functional teams.

Preferred Experience and Skills

• Hands-on proficiency with mechanistic modeling and simulation platforms (e.g., GastroPlus, Simcyp, Phoenix WinNonlin, PK-Sim, MATLAB, or Python/R).
• Experience with high-concentration and/or large-volume SC biologic delivery, including co-formulation approaches or permeation-enhancing technologies.
• Direct experience authoring biopharmaceutics and comparability sections for regulatory filings (IND/BLA) or supporting agency briefing books.
• Prior experience evaluating device-biologic interactions and human factors considerations for pre-filled syringes, autoinjectors, or wearable delivery systems.
• Record of sustained scientific contributions, including peer-reviewed publications, invited presentations, or active participation in cross-industry consortia.

Required Skills

• Biologics Drug Product, Biopharmaceutics, Bridging Strategies, Comparability, Drug Delivery, Formulation Characterization, Immunogenicity Risk Assessment, In Vitro-In Vivo Translation, Matrix Leadership, Pharmacokinetics (PK), Pre-Filled Syringes & Autoinjectors, Regulatory Submissions, Subcutaneous Absorption, Translational Modeling.

Required Skills

Biopharmaceuticals, Cell Line Development, Clinical Pharmacology, Downstream Process Development, Drug Delivery Technology, Drug Delivery, Expression Vectors, Immunogenicity, Molecular Biology, Pharmaceutical Formulations, Pharmaceutical Process Development, Pharmaceutical Sciences, Pharmacokinetics, Physical Characterization, Stable Cell Lines

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:

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The primary location for this posting is

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is

$142,400.00 - $224,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

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

Employee Status: Regular

Relocation: Domestic

VISA Sponsorship: No

Travel Requirements: 10%

Flexible Work Arrangements: Not Applicable

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): n/s

Job Posting End Date

11/20/2026*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.