Biopharmaceutics Strategy Lead — Subcutaneous

Merck & Co.; Rahway (NJ); Vor Ort; USD 142.000 - 224.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Dental insurance

Vision insurance

401(k)

Paid holidays

Vacation

Sick days

Zusammenfassung

Merck & Co. seeks an Associate Principal Scientist to lead biopharmaceutics strategy for SC biologics from early formulation screening to commercialization and lifecycle management.

You will work with formulation, analytical, device engineering, pharmacokinetics, and clinical pharmacology teams to apply mechanistic principles and modeling to evaluate SC absorption, formulation, and device compatibility, bridging processes and immunogenicity risk. The role requires a Ph.D.

Qualifikationen

• Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemical or Biomedical Engineering with 3+ years of relevant experience or Master’s with 8+ years.
• Strong biologics drug product development experience focusing on SC absorption and translational PK.
• Experience leading cross-functional matrix teams and regulatory engagements.

Aufgaben

• Lead SC Biopharmaceutics Strategy across development stages.
• Drive translation and product bridging with mechanistic approaches.
• Assess immunogenicity and bio-performance risk related to formulation and devices.
• Influence governance and regulatory strategy; draft or review regulatory submissions.
• Advance scientific capabilities; mentor staff and contribute to external engagements.

Kenntnisse

SC Biopharmaceutics

Cross-functional leadership

Translational PK

Regulatory strategy

Immunogenicity risk

Oral/Parenteral translational

Ausbildung

Ph.D. + 3+ yrs

M.S. + 8+ yrs

Tools

GastroPlus

Simcyp

Phoenix WinNonlin

PK-Sim

MATLAB

Python/R

Jobbeschreibung

Merck & Co. seeks an Associate Principal Scientist to lead biopharmaceutics strategy for SC biologics from early formulation screening to commercialization and lifecycle management.

You will work with formulation, analytical, device engineering, pharmacokinetics, and clinical pharmacology teams to apply mechanistic principles and modeling to evaluate SC absorption, formulation, and device compatibility, bridging processes and immunogenicity risk. The role requires a Ph.D.