Associate Principal Scientist, Biopharmaceutics

MSD • Rahway, NJ

6d

About The Position

We are seeking an experienced Associate Principal Scientist to lead biopharmaceutics strategy for subcutaneously administered biologics across the pipeline, from early formulation screening through late-stage commercialization and lifecycle management. The role works closely with formulation, analytical, device engineering, pharmacokinetics, and clinical pharmacology teams, applying mechanistic principles, quantitative translational modeling, and experimental frameworks to evaluate SC absorption, formulation and device compatibility, product bridging, and immunogenicity risk. The successful candidate will combine scientific rigor with matrix leadership to de-risk clinical delivery and influence program decisions at key governance milestones.

The position is based primarily in Rahway, New Jersey. Travel requirements are 10%, and relocation is domestic. VISA sponsorship is not available. Flexible work arrangements are listed as not applicable; shift is not indicated.

Requirements

• Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemical or Biomedical Engineering, or a related scientific discipline, with at least 3 years of relevant experience; alternatively, a relevant master's degree with at least 8 years of relevant industry experience.
• Demonstrated expertise in biologics drug product development, with a strong focus on 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 such as vial to PFS/autoinjector, and formulation bridging.
• Working understanding of the interplay between biologic quality attributes, including aggregation, opalescence, viscosity, and particle formation, delivery devices, and clinical immunogenicity/ADA impact.
• Strong critical thinking and problem-solving skills, including 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.

Nice To Haves

• Hands-on proficiency with mechanistic modeling and simulation platforms such as 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.

Responsibilities

• Define integrated experimental and modeling strategies to guide formulation, dose volume, injection site, and device decisions across development.
• Apply mechanistic and quantitative approaches to translate preclinical findings, assess exposure variability, and support formulation, device, process, scale, and site changes.
• Evaluate how product quality attributes, formulation, particles, aggregates, and delivery conditions may affect local tolerability, pharmacokinetics, and immunogenicity.
• Communicate risks and recommendations at program and governance forums.
• Author or review relevant regulatory submissions and health authority briefing materials.
• Develop predictive tools and experimental approaches, mentor scientists, and contribute to external scientific engagement.

Benefits

• Medical, dental, and vision healthcare benefits and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree