Biologics Analytics Lead Scientist, R&D

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

Avantages offerts par ce poste

Annual bonus

Long-term incentive

Comprehensive benefits

Résumé du poste

Merck & Co. is seeking an Associate Principal Scientist in Rahway, NJ to lead development and qualification of analytical methods for monoclonal proteins and other complex biologics. You will design experiments, interpret data, and drive cross-functional collaboration to support drug substance and product development.

The role emphasizes leadership of small teams, rigorous documentation, and communication of results for regulatory filings and project milestones in a fast-paced environment.

Qualifications

• Strong background in separations science.
• Experience with UPLC/HPLC analysis of biologics (SEC, RP, IEX).
• Experience with process- and impurity-related residual assay development using molecular biology and immunoassay techniques.
• Background in Analytical Methodologies and statistics for setting specifications.

Responsabilités

• Develop, qualify, implement, troubleshoot, and transfer analytical methods for monoclonal proteins or other complex therapeutic proteins.
• Design, execute and/or direct design of experiments and data interpretation.
• Lead transfer of assays and ensure documentation meets program deadlines.
• Author and review internal technical reports and regulatory filing sections (IND, BLA).
• Mentor small groups and collaborate cross-functionally on projects.

Connaissances

Adaptability

Analytical Method Development

Assay Development

Biological Assay Development

Cell-Based Assays

Chromatographic Techniques

Cross-Functional Teamwork

External Collaboration

HRMS

LC-MS

Mass Spectrometry Analysis

Optimism

PAT

Protein Analysis

Teamwork

Formation

Bachelor's degree in Chemistry, Biochemistry, Engineering, Pharmaceuticals, or related field

Description du poste

Merck & Co. is seeking an Associate Principal Scientist in Rahway, NJ to lead development and qualification of analytical methods for monoclonal proteins and other complex biologics. You will design experiments, interpret data, and drive cross-functional collaboration to support drug substance and product development.

The role emphasizes leadership of small teams, rigorous documentation, and communication of results for regulatory filings and project milestones in a fast-paced environment.