Senior Specialist, Raw Material Analytics & Characterization

MSD Malaysia; Northern (KY); Hybrid; USD 117,000 - 184,000; Full time

Job summary

Merck seeks a Senior Specialist in Raw Material Analytical Characterization to lead materials characterization and risk assessment for biologics input materials. You will identify CMAs, study lot variability, and ensure process robustness and supply continuity.

The role requires collaboration with Manufacturing, Quality, Procurement, and Regulatory teams to develop robust analytical strategies and support regulatory filings.

Qualifications

• Bachelor’s degree in Analytical Chemistry or related field with industry experience preferred.
• Experience in biopharmaceutical analytical sciences and materials characterization is advantageous.
• Familiarity with GMP regulatory expectations and quality systems is desirable.

Responsibilities

• Lead raw material analytical characterization and risk assessment.
• Develop and apply analytical methods for raw materials used in biologics manufacturing.
• Collaborate with cross‑functional teams to mitigate material-related risks and support regulatory submissions.

Skills

Analytical Chemistry

Bioprocess Understanding

Data Analysis Tools

Problem Solving

Education

Bachelor’s degree in Analytical Chemistry or related

Master’s or Ph.D. in relevant field

Tools

LC-MS

HPLC

UPLC

UHPLC

Job description

Merck seeks a Senior Specialist in Raw Material Analytical Characterization to lead materials characterization and risk assessment for biologics input materials. You will identify CMAs, study lot variability, and ensure process robustness and supply continuity.

The role requires collaboration with Manufacturing, Quality, Procurement, and Regulatory teams to develop robust analytical strategies and support regulatory filings.