Associate Principal Scientist, Biopharmaceutics

1000 Merck Sharp & Dohme LLC; Rahway (NJ); Sur place; USD 142 000 - 224 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision insurance

401(k) retirement plan

Paid holidays and vacation

Résumé du poste

Merck & Co., Inc. in Rahway, NJ is seeking an Associate Principal Scientist to lead biopharmaceutics strategy for subcutaneously administered biologics across the pipeline, from early formulation screening to lifecycle management.

You will collaborate with formulation, analytical, device engineering, pharmacokinetics, and clinical pharmacology teams to apply modeling and experimental frameworks to evaluate SC absorption, device compatibility, and immunogenicity risk.

Qualifications

• Ph.D. in Pharmaceutical Sciences or related field with 3+ years of industry experience.
• Alternatively Master’s with 8+ years industry experience.
• Strong expertise in biologics drug product development and SC pharmacokinetics.
• Experience leading cross-functional matrix teams.

Responsabilités

• 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.

Connaissances

Biopharmaceutics

Drug product development

Translational PK

Matrix leadership

Regulatory submissions

Immunogenicity risk assessment

Subcutaneous absorption

Pharmacokinetics (PK)

Mechanistic modeling

Translational modeling

Formation

Ph.D. in Pharmaceutical Sciences

Master’s degree in a relevant discipline

Outils

GastroPlus

Simcyp

Phoenix WinNonlin

PK-Sim

MATLAB

Python/R

Description du poste

Associate Principal Scientist - Biopharmaceutics Strategy (SC Biologics)

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: 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.


• 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.


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

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

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.

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.

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.

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.

Job Posting End Date: 11/20/2026.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.