Biopharmaceutics Strategy Lead – SC Delivery

Merck; Rahway (NJ); Sur place; USD 142 000 - 224 000; Plein temps

Résumé du poste

Merck in Rahway, NJ seeks an Associate Principal Scientist to lead subcutaneous biopharmaceutics strategy across the development pipeline. You will define experimental and modeling frameworks to inform formulation, dose, injection devices, and bridging strategies while collaborating with formulation, analytical, PK, and clinical teams.

You will apply mechanistic principles and translational PK to de-risk clinical delivery, influence governance decisions, and mentor scientists in a matrix

Qualifications

• Ph.D. in Pharmaceutical Sciences or related field with 3+ years of relevant experience or Master’s with 8+ years
• Expertise in biologics drug product development and subcutaneous absorption mechanisms
• Experience leading cross-functional matrix development teams and translating preclinical findings into clinical decisions
• Ability to communicate complex data clearly to senior leadership and regulators
• Experience with device transitions and bridging strategies for regulatory filings

Responsabilités

• Define integrated experimental and modeling strategies for SC biopharmaceutics
• Translate preclinical findings and support formulation, device, process changes
• Assess immunogenicity and bio-performance risks in development programs
• Contribute to regulatory submissions and health authority briefing materials
• Mentor scientists and develop predictive tools and external scientific engagements

Connaissances

Biologics Drug Product

Biopharmaceutics

Translational PK

Regulatory Submissions

Subcutaneous Absorption

Formation

Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemical or Biomedical Engineering, or related

Master’s degree in a relevant discipline

Outils

GastroPlus

Simcyp

Phoenix WinNonlin

PK-Sim

MATLAB

Python/R

Description du poste

Merck in Rahway, NJ seeks an Associate Principal Scientist to lead subcutaneous biopharmaceutics strategy across the development pipeline. You will define experimental and modeling frameworks to inform formulation, dose, injection devices, and bridging strategies while collaborating with formulation, analytical, PK, and clinical teams.

You will apply mechanistic principles and translational PK to de-risk clinical delivery, influence governance decisions, and mentor scientists in a matrix